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1 | RAMS_CIF.zip\RAMS_CIF\RAMS_CIF\docs | RAMS_Integration_Requirements_Specification_Document_Revised_1.5.docx | Thu Jun 22 12:35:42 2017 UTC |
2 | RAMS_CIF.zip\RAMS_CIF\RAMS_CIF\docs | RAMS_Integration_Requirements_Specification_Document_Revised_1.5.docx | Thu Jun 22 15:21:47 2017 UTC |
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1 | Research A dministrat ive Manage ment Syste m (RAMS) I ntegration | |
2 | Requiremen ts Specifi cation Doc ument | |
3 | ||
4 | January 20 17 | |
5 | Version 1. 5 | |
6 | Department of Vetera ns Affairs | |
7 | Revision H istory | |
8 | Note: The revision h istory cyc le begins once chang es or enha ncements a re request ed after t he Require ments Spec ification Document h as been ba selined. | |
9 | Date | |
10 | Version | |
11 | Descriptio n | |
12 | Author | |
13 | 1/3/2016 | |
14 | 1.5 | |
15 | Review for 2001 subm ission | |
16 | ||
17 | 10/03/2016 | |
18 | 1.4 | |
19 | Final Vers ion of RSD for RAMS Integratio n | |
20 | Bylight | |
21 | 08/15/16 | |
22 | 1.3 | |
23 | 2.6 Functi onal Requi rements: A dded R&D, Safety, an d IACUC | |
24 | 2.4 Disast er Recover y Specific ation | |
25 | 2.3.Design Constrain ts Specifi cation - D ependencie s and Cons traints- A dditional Identified Design Co nstraints: | |
26 | 2.3.Design Constrain ts Specifi cation - D ependencie s and Cons traints- C onstraints - Not a r equirement for RAMS Integratio n | |
27 | 2.2.Busine ss Rules S pecificati on: Added correspond ing requir ement to e ach Busine ss Rule | |
28 | Annie M. L ee | |
29 | 7-01-2016 | |
30 | 1.2 | |
31 | Scope clar ification as per PWS | |
32 | ByLight | |
33 | 6-15-2016 | |
34 | 1.1 | |
35 | Scope revi sed to PWS | |
36 | ByLight | |
37 | 2-05-2016 | |
38 | 1.0 | |
39 | Updated Fi nal Versio n Sent for Approval | |
40 | Engility | |
41 | 1-18-2016 | |
42 | 0.2 | |
43 | Final Vers ion Sent f or Approva l – Return ed for Upd ates | |
44 | Engility | |
45 | 12-23-2015 | |
46 | 0.1 | |
47 | Initial Ve rsion | |
48 | Engility | |
49 | Artifact R ationale | |
50 | The Requir ements Spe cification Document (RSD) reco rds the re sults of t he specifi cation gat hering pro cesses car ried out d uring the Requiremen ts phase. The RSD is generally written b y the func tional ana lyst(s) an d should p rovide the bulk of t he informa tion used to create the test p lan and te st scripts . It shoul d be updat ed for eac h incremen t. | |
51 | The level of detail contained in this RS D should b e consiste nt with th e size and scope of the projec t. It is n ot necessa ry to fill out any s ections of this docu ment that do not app ly to the project. T he resourc es necessa ry to crea te and mai ntain this document during the life cycl e of a lar ge project should be acknowled ged and cl early refl ected in p roject sch edules. Do not dupli cate data that is al ready defi ned in ano ther docum ent or a s ection in this docum ent; note in the sec tion where the infor mation can be found. | |
52 | ||
53 | Instructio ns | |
54 | Activity | |
55 | New Capabi lity (1) | |
56 | Feature En hancement (2) | |
57 | Field Depl oyment (A) | |
58 | No | |
59 | No | |
60 | Cloud/Web Deployment (B) | |
61 | Yes | |
62 | Yes | |
63 | Mobile App lication ( C) | |
64 | No | |
65 | No | |
66 | ||
67 | Table of C ontents | |
68 | 1.Introduc tion1 | |
69 | 1.1.Purpos e5 | |
70 | 1.2.Scope5 | |
71 | 1.3.Refere nces6 | |
72 | 2.Overall Descriptio n7 | |
73 | 2.1.Access ibility Sp ecificatio ns7 | |
74 | 2.2.Busine ss Rules S pecificati on7 | |
75 | 2.3.Design Constrain ts Specifi cation9 | |
76 | 2.4.Disast er Recover y Specific ation11 | |
77 | 2.5.Docume ntation Sp ecificatio ns11 | |
78 | 2.6.Functi onal Speci fications1 2 | |
79 | 2.7.Graphi cal User I nterface ( GUI) Speci fications4 9 | |
80 | 2.8.Multi- Divisional Specifica tions49 | |
81 | 2.9.Perfor mance Spec ifications 49 | |
82 | 2.10.Quali ty Attribu tes Specif ication51 | |
83 | 2.11.Relia bility Spe cification s51 | |
84 | 2.12.Scope Integrati on53 | |
85 | 2.13.Secur ity Specif ications53 | |
86 | 2.14.Syste m Features 77 | |
87 | 2.15.Usabi lity Speci fications7 7 | |
88 | 3.Purchase d Componen ts83 | |
89 | 4.Estimati on83 | |
90 | 5.Approval Signature s85 | |
91 | Appendix A : Non-Func tional Req uirements8 6 | |
92 | Appendix B : Acronyms 101 | |
93 | ||
94 | Introducti on | |
95 | The Vetera ns Health Administra tion (VHA) Office of Research and Develo pment (ORD ) is respo nsible for the manag ement and administra tion of th e Departme nt of Vete rans Affai rs (VA) in tramural r esearch pr ogram. The ORD aims to improve the effic iency and performanc e of the V A research program b y implemen ting an en terprise-w ide Resear ch Adminis trative Ma nagement S ystem (RAM S) accessi ble to act ive field research o ffices and the ORD C entral Off ice. | |
96 | The curren t implemen tation of RAMS suppo rts the ma jor busine ss functio ns of the Institutio nal Review Board (IR B) and pro vides a co mmon datab ase for ad ministrati ve researc h program data. This document specifies the requir ements for new funct ionality a nd integra tion of RA MS to allo w manageme nt of rese arch proje cts and st udies by t he Researc h and Deve lopment Co mmittee (R &D), the I nstitution al Review Board (IRB ), Institu tional Ani mal Care a nd Use Com mittee (IA CUC), Subc ommittee o n Research Safety (S RS), and l ocal resea rch office s reportin g to ORD. | |
97 | This docum ent provid es a narra tive descr iption of these thre e committe es: the Re search and Developme nt Committ ee (R&D), the Instit utional An imal Care and Use Co mmittee (I ACUC), and the Subco mmittee on Research Safety (SR S). | |
98 | The Resear ch and Dev elopment ( R&D) Commi ttee | |
99 | The Resear ch and Dev elopment ( R&D) Commi ttee is re sponsible for ensuri ng the eff ective ope ration of the resear ch program through o versight o f the R&D Committee’ s subcommi ttees, and making ap propriate recommenda tions, inc luding spa ce and res ource need s, to the medical ce nter Direc tor based on the Com mittee’s o versight a nd evaluat ion of the research program. T he R&D Com mittee ass ists the m edical cen ter Direct or in fulf illing res ponsibilit ies for th e facility ’s researc h program, and addit ional func tions may also inclu de review and approv al of indi vidual res earch proj ects. | |
100 | Every VA f acility co nducting r esearch mu st have, o r establis h, an R&D Committee of record. A VA faci lity may a lso secure the servi ces of an R&D Commit tee from a nother VA facility, from the V eterans In tegrated S ervice Net work (VISN ), a regio nal VA R&D Committee that serv es multipl e VA facil ities, or other VA e ntity thro ugh the us e of a wri tten agree ment that describes the roles and respon sibilities of all pa rties. Ren ewal of th e agreemen t must occ ur 60 days prior to the review of propos als by R&D subcommit tee or it is to be a utomatical ly termina ted. If te rminated, that commi ttee may n o longer s erve as th e R&D Comm ittee of r ecord for the facili ty. | |
101 | The R&D Co mmittee is responsib le, throug h the Chie f of Staff (COS), to the medic al center Director f or: | |
102 | Advising a nd assisti ng the med ical cente r Director to provid e oversigh t, plannin g, and exe cution of the local research P rogram; an d | |
103 | Assisting the medica l center D irector to maintain high stand ards throu ghout the R&D Progra m. Those s tandards i nclude ens uring the: | |
104 | Scientific and ethic al quality of VA res earch proj ects; | |
105 | Protection of human subjects i n research ; | |
106 | Safety of personnel engaged in research; | |
107 | Welfare of laborator y animals; | |
108 | Security o f VA data; and | |
109 | Security o f VHA rese arch labor atories. | |
110 | The R&D Co mmittee is assisted by the Ass ociate Chi ef of Staf f (ACOS) f or R&D and the Admin istrative Officer (A O) for R&D in carryi ng out its duties. N OTE: In sm all resear ch program s, a Resea rch Coordi nator may be appoint ed in lieu of an ACO S for R&D. For purpo ses of thi s Handbook , “ACOS fo r R&D” inc ludes the Research C oordinator . (June 16 , 2009 VHA HANDBOOK 1200.01 3) | |
111 | Research i n which th e facility is to be engaged ma y not be u ndertaken without re view and w ritten app roval of a ll appropr iate subco mmittees o f the R&D Committee. The inves tigator mu st not ini tiate a re search pro ject until after bei ng notifie d in writi ng by the ACOS for R &D that th e project has been a pproved by all relev ant commit tees, subc ommittees, or other entities. The Instit utional Re view Board (IRB), Su bcommittee on Resear ch Safety (SRS), Ani mal Care a nd Use Com mittee (IA CUC), and other such entities must notif y the R&D Committee of project approvals via a wri tten commu nication s igned by a voting co mmittee me mber for t he committ ee. The R& D Committe e must not ify the As sociate Ch ief of Sta ff (ACOS) for R&D of project a pprovals v ia a writt en communi cation sig ned by a v oting R&D Committee member for the commi ttee. Noti fications need not b e in the f orm of min utes, nor is a separ ate docume nt needed for each a pproved pr oject. A s ingle memo randum tha t lists by title, pr oject numb er, or sim ilar uniqu e identifi er all of the protoc ols receiv ing final approval a t a given meeting is sufficien t. Once R& D Committe e approval has been given, the research becomes VA -approved research. | |
112 | The RAMS i ntegration solution shall enab le the R&D Committee to: | |
113 | 1.Manage t he activit ies of the R&D Commi ttee, whic h includes the follo wing: | |
114 | Adding use rs and set ting permi ssions | |
115 | Adding mem bers to co mmittees a nd trackin g appointm ent dates | |
116 | Allow the R&D Commit tee to com plete requ ired repor ts and for ms online | |
117 | Allow the R&D Commit tee to sch edule meet ings, noti fy members and colle ct feedbac k from oth er subcomm ittees | |
118 | Allow the R&D Commit tee to pub lish and s tore meeti ng minutes | |
119 | Ensure com pliance wi th federal and VA re gulations | |
120 | 2.Provide communicat ions porta ls among t he R&D Com mittee and subcommit tee | |
121 | 3.Provide easily acc essible re porting ca pability a t the loca l headquar ters level s | |
122 | 4.Enable t he ORD Cen tral Offic e to creat e reports covering e nterprise wide resea rch activi ties. | |
123 | The Instit utional An imal Care and Use Co mmittee (I ACUC) | |
124 | The IACUC (Instituti onal Anima l Care and Use Commi ttee) is t he local c ommittee c harged wit h ensuring complianc e with ani mal resear ch regulat ions and g uidelines. In the VA system, t he IACUC i s organize d administ ratively a s a subcom mittee of the Resear ch and Dev elopment C ommittee. | |
125 | The VA IAC UC must pe rform the review and oversight functions required by the Pub lic Health Service ( PHS) Polic y (see Sec . IV.B., I V.C., and IV.F), the Guide (se e Monitori ng the Car e and Use of Animals ), the Ani mal Welfar e Act (AWA ) [see 7 U .S.C. 2143 (b)(1)], t he United States Dep artment of Agricultu re (USDA) AWA (see 9 Code of F ederal Reg ulations ( CFR) 2.31) , VA polic y, and any other Fed eral regul ations tha t impact I ACUC funct ion. | |
126 | The IACUC is respons ible for t he followi ng: | |
127 | Semi-Annua l Program and Facili ty Self-As sessment R eviews | |
128 | According to the USD A Animal W elfare Act Regulatio ns and Sta ndards (se e 9 CFR §2 .31(c)(1)) and PHS P olicy, the designate d VA IACUC must perf orm a self -assessmen t review o f the prog ram of ani mal care a nd researc h use, and an inspec tion of th e animal f acilities and husban dry practi ces at lea st every 6 months. T his self-a ssessment review mus t be condu cted using the stand ards estab lished in the most c urrent Gui de (see “I nstitution al Animal Care and U se Committ ees”), PHS Policy (s ee Sec. IV .B), the A nimal Welf are Act [s ee 7 U.S.C . 2143(b)( 3) and (b) (4)], USDA AWA [see 9 CFR §2.3 1(c)(2)], and this V A policy. | |
129 | Research P roposal Re views | |
130 | The IACUC must revie w and appr ove, requi re modific ations in (to secure approval) , or withh old approv al of all research p roposals i nvolving s pecies and activitie s included within th e definiti on of an “ animal”. A ll researc h projects involving animals m ust be app roved by t he IACUC a nd then by the R&D C ommittee p rior to co mmencement . The date of contin uing revie w is based on the da te of IACU C approval . The IACU C must rev iew propos ed researc h at conve ned meetin gs at whic h a quorum (a majori ty of voti ng members ) is prese nt. In ord er for the research to be appr oved, it m ust receiv e the appr oval of a majority o f those vo ting membe rs present at the me eting. | |
131 | IACUC Semi -Annual Se lf-Assessm ent Review s | |
132 | Semi-annua l Self-Ass essment Re views must be prepar ed by the IACUC. No later than 60 days a fter the s elf-assess ment revie w date, a copy of th e approved report si gned by a majority o f IACUC me mbers and the medica l facility Director must be fo rwarded to the Chief Veterinar y Medical Officer (C VMO)’s off ice throug h the ACOS for R&D a nd the med ical facil ity Direct or. | |
133 | Annual VA Veterinary Medical U nit (VMU) Report | |
134 | An annual VA VMU Rep ort for th e previous fiscal ye ar must be completed using the Web site designed f or that pu rpose by J anuary 15. In contra st to the USDA Annua l Report o f Research Facility, all anima l species used must be include d in the A nnual VMU Report. In structions for prope rly comple ting this report can be obtain ed from th e CVMO. | |
135 | IACUC will be incorp orated int o the RAMS Integrati on project which wil l allow fo r the mana gement of IACUCs res earch proj ects and s tudies. | |
136 | The Subcom mittee on Research S afety (SRS ) | |
137 | The Subcom mittee on Research S afety (SRS ) is respo nsible for ensuring the safety of person nel engage d in VA re search con ducted by the Office of Resear ch and Dev elopment ( ORD). In t he VA syst em, the IA CUC is org anized adm inistrativ ely as a s ubcommitte e of the R esearch an d Developm ent Commit tee. | |
138 | The SRS ve rifies tha t safety s tandards a re being m et and res olves defi ciencies b y working with the f ollowing r oles: | |
139 | Facility D irectors | |
140 | ACOS | |
141 | R&D Commit tee | |
142 | Principle Investigat or (PI) or PI Design ee | |
143 | The SRS is responsib le for the following : | |
144 | Reviewing all resear ch activit ies involv ing biolog ical, chem ical, phys ical, and radiation hazards fo r complian ce with al l applicab le regulat ions, poli cies, and guidelines prior to submission for R&D f unding. Th is include s a review of all re search app lications for fundin g that wil l be condu cted at th e VA facil ity or by VA personn el with VA funding l ocated off -site. | |
145 | Providing written no tification of the re sults of S RS review to the R&D Committee , the Rese arch Offic e, and the PI. | |
146 | Reviewing annually a ll active research p rotocols i nvolving b iological, chemical, physical, and radia tion hazar ds, regard less of fu nding stat us or sour ce. The da te of cont inuing rev iew will b e based o n the date of SRS ap proval. Re search pro tocol chan ges not in cluded in the origin al applica tion must be documen ted on an amended Re search Pro tocol Safe ty Survey (RPSS) (se e Appendix F) and mu st be subm itted to a nd reviewe d by SRS p rior to th e implemen tation of the change s. | |
147 | Ensuring t hat a comp lete list of all pro ducts cont aining che micals des ignated or identifie d by the O ccupationa l Safety & Health Ad ministrati on (OSHA) or the Env ironmental Protectio n Agency ( EPA) as “h azardous” (see subpa r. 6c (8), subpar. 6 e (2), or applicable State req uirements) has been submitted to the Saf ety Office r for revi ew and app roval prio r to the s ubmission of a proto col for lo cal review . | |
148 | Coordinati ng all saf ety-relate d activiti es in rese arch labor atories in cluding ma ndatory an d non-mand atory trai ning, safe ty inspect ions, acci dent repor ting, and liaison ac tivities w ith all fa cility saf ety commit tees and o fficials t o include: | |
149 | Coordinati ng follow- up evaluat ions to en sure that deficienci es cited d uring insp ections ar e permanen tly and ef fectively abated, an d | |
150 | Reporting follow-up results to the R&D C ommittee. | |
151 | Reporting operationa l problems or violat ions of di rectives t o the Rese arch Offic e within 3 0 days of occurrence or detect ion, unles s SRS dete rmines tha t a report has been previously filed by the PI. | |
152 | Identifyin g the need for healt h surveill ance of pe rsonnel in volved in individual research projects; and if app ropriate, advising t he R&D Com mittee and Employee Health Pra ctitioner on the nee d for such surveilla nce. | |
153 | Maintainin g adequate documenta tion of al l the SRS or equival ent subcom mittee act ivities. | |
154 | Forwarding minutes o f SRS to t he Researc h Office. | |
155 | Ensuring t hat all la boratory p ersonnel r eceive ann ual resear ch specifi c safety t raining. | |
156 | Holding SR S meetings at least quarterly. | |
157 | Ensuring c oordinatio n with oth er regulat ory progra ms, person nel, or co mmittees s uch as the Radiation Safety Of ficer or R adiation S afety Comm ittee. | |
158 | Ensuring t he collect ion of app ropriate p ersonnel s amples to make emplo yee exposu re determi nations wh enever the proposed use of lab oratory ch emicals ma y potentia lly exceed OSHA Perm issible Ex posure Lim its or Act ion Levels . | |
159 | Evaluating annually the effect iveness of the labor atory’s Ch emical Hyg iene Plan and making necessary revisions . | |
160 | Ensuring t he review of investi gation rep orts of al l lost-tim e injuries and all s ignificant adverse e nvironment al events. | |
161 | Ensuring t he proper reporting of injury and illnes s trends t o the R&D Committee, as approp riate. | |
162 | Requesting , when app ropriate, the appoin tment of a n ad hoc c ommittee ( consisting of member s with app ropriate e xpertise) to investi gate and r eport on o ccupationa l injuries , illnesse s, and adv erse envir onmental e vents. | |
163 | Ensuring t he develop ment of a policy for the prese rvation of employee medical an d OSHA exp osure reco rds and en vironmenta l records (i.e., haz ardous was te, air mo nitoring). | |
164 | Cooperatin g with app ropriate m edical cen ter person nel to rev iew the qu antity and type of h azardous w aste gener ated by ea ch PI annu ally. | |
165 | Providing technical assistance , where ap propriate, in recycl ing progra ms and red uction of the quanti ty of wast e. | |
166 | RAMS Integ ration wil l provide a collabor ative syst em for SRS to work w ith other areas of O RD to mana ge hazardo us materia ls, safety risks, an d laborato ry safety data. Addi tionally, SRS will b e able to manage RAM S access a nd securit y for SRS users, as well as au tomate man agement of safety do cuments, i ncluding t he Researc h Protocol Safety Su rvey (RPSS ). | |
167 | Purpose | |
168 | The purpos e of this RSD is to document t he require ments of t he RAMS In tegration solution t hat will b e develope d by Infor mation Tec hnology (I T) resourc es acquire d through a contract . | |
169 | These requ irements h ave been r efined thr ough a ser ies of ext ensive int erviews an d workshop s with VA Users, bus iness spon sors, and other stak eholders. The initia l business requireme nts have b een identi fied in th e approved RAMS Inte gration Bu siness Req uirements Document ( BRD). | |
170 | This docum ent is bas ed on the Office of Enterprise Developme nt (OED) P roPath tem plate for requiremen ts. This d ocument’s organizati on and con tent refle ct VA guid elines wit h the Proj ect Manage ment Accou ntability System (PM AS). The i ntended au dience for this RSD is the VA Integrated Project T eam (IPT), with acce ss authori zed and co ntrolled b y the VA P roject Man ager. | |
171 | Scope | |
172 | The VA res earch prog ram curren tly uses a variety o f informat ion system s and supp lemental d atabase ap plications to suppor t research activitie s at the C entral Off ice and lo cal field levels. Th e existing non-stand ard archit ecture has led to in consistent data mana gement pro cesses acr oss the na tional pro gram. This has also resulted i n delays w hen respon ding to Ce ntral Offi ce-initiat ed data ca lls. | |
173 | The scope is to incl ude a sing le front-e nd, web-ba sed, data management and repor ting appli cation fra mework, an d centrali zed back-e nd databas e system. The RAMS I ntegration is intend ed to serv e as a mul tipurpose tool for O RD Central Office an d VA Medic al Center (VAMC) fie ld researc h offices. The requi rements ar e scoped t o provide the capabi lity to cr eate and t rack admin istrative data for e ach projec t assigned to the lo cal resear ch office; manage re search ove rsight com mittees an d subcommi ttees; tra ck researc h personne l assignme nts, train ing requir ements, an d certific ations; ma nage labor atory data , includin g space al locations and equipm ent; and s upport req uired repo rting to O RD. | |
174 | This syste m will ser ve as a co mmunicatio n portal t hat is acc essible to ORD and t he researc h offices. It will r equire suf ficient se rver space to exchan ge numerou s tools an d resource s, many of which are graphic-h eavy and r equire lar ge amounts of storag e capacity . | |
175 | The RAMS I ntegration will serv e as a mul tipurpose tool for t he Veteran s Affairs Central Of fice (VACO ) ORD and VAMC field research offices. W ith the RA MS Integra tion, thes e offices will be ab le to: | |
176 | create and track adm inistrativ e data for individua l projects that are active or pending at local res earch site s; | |
177 | manage res earch over sight comm ittees and sub-commi ttees; | |
178 | track rese arch perso nnel assig nments, tr aining req uirements, and certi fications; | |
179 | manage lab oratory sp ace and eq uipment in ventory, i ncluding s pace alloc ations and equipment ; and | |
180 | support re quired rep orting to ORD. | |
181 | References | |
182 | The follow ing docume nts were r eferenced in the dev elopment o f this Req uirements Specificat ion Docume nt (RSD): | |
183 | RAMS Integ ration BRD 5-1-15 | |
184 | RAMS Elabo rated Requ irements D ocument 05 OCT15 | |
185 | 1200 VHA R esearch Pr ogram | |
186 | VHA Handbo ok 1200.01 Research and Develo pment Comm ittee | |
187 | VHA Handbo ok 1200.05 Human Sub jects | |
188 | VHA Handbo ok 1200.07 Animal Re search | |
189 | VHA Handbo ok 1200.08 Safety | |
190 | Additional reference s: | |
191 | ProPath We bsite | |
192 | Project Ma nagement A ccountabil ity System (PMAS) Pr ogram Mana gement Doc ument Repo sitory | |
193 | Section 50 8 Requirem ents | |
194 | Technical Reference Model (TRM ) | |
195 | Department of Vetera ns Affairs Handbook 6500 | |
196 | VA Directi ve 6500 – Informatio n Security Program | |
197 | Office of Informatio n and Tech nology (OI &T) Techni cal Servic es Project Repositor y (TSPR) W ebsite | |
198 | NARA – Nat ional Arch ives Recor ds Associa tion Polic y | |
199 | RCS – Reco rds Contro l Schedule | |
200 | ||
201 | ||
202 | ||
203 | ||
204 | ||
205 | ||
206 | ||
207 | ||
208 | ||
209 | ||
210 | ||
211 | ||
212 | ||
213 | ||
214 | ||
215 | ||
216 | ||
217 | ||
218 | ||
219 | ||
220 | ||
221 | ||
222 | ||
223 | ||
224 | Overall De scription | |
225 | The RAMS I ntegration is intend ed to impr ove on the current v ersion of RAMS. The functional ity specif ications, among othe r requirem ents, will address t he increas ed capabil ity to cre ate and tr ack admini strative d ata for ea ch project assigned to the loc al researc h office, and manage oversight committee s and subc ommittees. The RAMS Integratio n will exp and the ca pability t o cover ma nagement o f other ty pes of res earch, suc h as anima l studies that are o verseen by the Insti tutional A nimal Care and Use C ommittee ( IACUC). | |
226 | The non-fu nctional r equirement s are addr essed in A ppendix A. | |
227 | Accessibil ity Specif ications | |
228 | The RAMS I ntegration will be c ompliant w ith all Se ction 508 IT accessi bility sta ndards gov erned unde r 29 U.S.C 794d, as well as an y more spe cific VA p olicies th at may app ly. Accord ing to VA Handbook 6 102, acces sibility i s ensuring that cont ent can be navigated and read by every U ser, regar dless of l ocation, e xperience, or the ty pe of comp uter techn ology used . VA Web m anagers mu st therefo re ensure that all W eb pages, documents, and files posted to the Web a nd/or to a collabora tion tool must be ac cessible. This inclu des .pdf, .xls, and .doc file types. Ref er to the VA’s Secti on 508 Bac kground an d Standard s page for more deta ils. | |
229 | Table 1: A ccessibili ty Specifi cations | |
230 | Req. ID | |
231 | Requiremen t | |
232 | Increment | |
233 | (1, 2, Fut ure) | |
234 | ACC-001 | |
235 | The RAMS I ntegration shall com ply with S ection 508 requireme nts. | |
236 | 1,2(VA Dir ective) | |
237 | ACC-002 | |
238 | The RAMS I ntegration system sh all comply with Acce ssibility Guidelines | |
239 | 1,2 (VA Di rective) | |
240 | Business R ules Speci fication | |
241 | In additio n to the E pics and U ser Storie s document ed in Sect ion 2.6 of this docu ment, the following business r ules apply to RAMS: | |
242 | The Princi pal Invest igator (PI ) or PI De signee can submit a study appl ication fo r review a nd complet e edits ba sed on fee dback. | |
243 | Unauthoriz ed Users a re not per mitted to access or edit study data. (pe rtains to 2.2.2 Add users and set permis sions – IA CUC, R&D, Safety, RC O) | |
244 | Entering a term in t he search box produc es a list of studies that have that term included in the abs tract. (p ertains to 2.3 Provi de capabil ity to pri nt complet e applicat ion (all s ections in one docum ent) | |
245 | When assig ning perso nnel to a project, t he system provides a n alert if a person' s training has lapse d. (pertai ns to 2.4. 2 Manage i nvestigato rs and per sonnel rel ated to IA CUC resear ch project s) | |
246 | The system calculate s which fo rms are re quired and provides links to c omplete th e form onl ine. (pert ains 2.5 S upport aut o fill rep orts and f orms requi red by R&D and subco mmittees.) | |
247 | When viewi ng a study online, a n "attach document" button is available to upload and tag do cuments. ( pertains 2 .6 Attach review com mittee for ms, includ ing data s ecurity, C OI, safety , radiatio n, and IRB or IACUC forms to p roject. Ta g uploaded forms by type, date and autho r.) | |
248 | The system accepts a waiver re quest and notifies I nvestment Review Boa rd (IRB) C oordinator . The syst em tracks the status of the re quest. (fo r IRB only ). (pertai ns to 2.7 Submit and track eli gibility a nd off-sit e waivers. ) | |
249 | The Admini strative O fficer (AO ) can sele ct Project Expenditu re Report to review expenses p er project . (pertain s to 2.8 T rack fisca l year exp enditures by project . All fiel ds capture d in curre nt RDIS Pa rt II shou ld be capt ured.) | |
250 | The AO can select Fu nding Stat us Report and view f unding sta tus for ea ch project by sponso r. (perta ins to 2.9 Track spo nsorship a nd funding status fo r projects .) | |
251 | The PI or the PI Des ignee is n otified 90 days befo re the Ann ual Report is due an d can comp lete the r eport usin g online f orms. (per tains to 2 .10.2 Subm it Annual and Final (or as nee ded) Proje ct Report – IACUC) | |
252 | An option to add, de lete, or c onfigure c ommittees is availab le on the System Adm inistrator (SA) tool page. (pe rtains to 3.1 Add or delete co mmittees b ased on si te SOP) | |
253 | The Commit tee roster tool is a vailable o n the Comm ittee Acti vities pag e. (pertai ns to 3.2. 2 Add memb ers to com mittees an d track ap pointment dates – IA CUC, Safet y, and R&D ) | |
254 | A User can choose to sign elec tronically when subm itting a d ocument th at require s signatur es. (perta ins to 3.9 Provide a mechanism for the u se of secu re electro nic signat ures for t he signing of all fo rms and co rresponden ce) | |
255 | The Assura nce and Ac creditatio n Checklis t is provi ded on the AO landin g page. (p ertains to 3.16 Trac k Federal Wide Assur ances, IRB and IACUC registrat ions, Memo randum of Understand ing (MOUs) , and othe r accredit ations) | |
256 | The Workfl ow configu ration too l is avail able on th e Local Sy stem Admin istrator ( LSA) landi ng page. (pertains to 3.17 A llow for s ite specif ic committ ee configu rations an d workflow s) | |
257 | A link is available in the on line study applicati on to acce ss and com plete Form 10-0398. (pertains to 3.19 A utomate cr eation of Research P rotocol Sa fety Surve y (RPSS) ( VA Form 10 -0398) | |
258 | A training record is available for resea rch person nel, and n otificatio ns are sen t to the P I, or the PI Designe e, and the User when training is about t o expire. (pertains to 4.2 Aut omate the tracking o f training , scope of practice, and all n ecessary c ertificati ons for PI s and othe r employee s) | |
259 | The report for Witho ut Compens ation (WOC ) staff an d appointm ent status is availa ble from t he AO land ing page. (pertains to 4.4 No tify WOC/I PA/VA empl oyee and s ponsor whe n appointm ent renewa l is requi red) | |
260 | The report of keys, badges, an d equipmen t assigned to person nel, is av ailable on the AO la nding page . (pertai ns to 4.5 Track key, PC, and b adge assig nments/iss ues) | |
261 | The Lab Sp ace Report is access ible from the AO lan ding page. (pertain s to 5.1 T rack labor atory spac e allocati ons) | |
262 | The LASIF form is av ailable on line as a component of RAMS. (pertains to 5.3 Gen erate and track annu al lab saf ety self-e valuation forms and lab safety ) | |
263 | The Data s haring agr eements ar e stored a s tagged d ocuments. (pertains to 5.6 Ma nage data sharing ag reements, data repos itory appr ovals and annual rep orts) | |
264 | Additional details a nd more sp ecific bus iness need s will be further do cumented i n the RAMS Integrati on System Design Doc ument (SDD ). The ant icipated c ompletion date of th e SDD is F ebruary 20 16. | |
265 | Design Con straints S pecificati on | |
266 | All softwa re develop ment by de velopers s hall confo rm to tech nology sta ndards as defined in the One-V A Technica l Referenc e Model (T RM). | |
267 | The new fu nctionalit y requeste d by the R esearch Ad ministrati ve Managem ent System (RAMS) pr oject span s across m ultiple ap plications and is us ed as a co mmunicatio ns portal that is ac cessible t o the ORD and resear ch offices . The foll owing disc ussion sum marizes so me, but no t all, of the design “constrai nts” that must be co nsidered t o integrat e and prop erly build the new f unctionali ty. Furthe r explanat ion is pro vided in t he more-de tailed req uirements analysis f or each of these top ics. | |
268 | Software i s develope d and main tained usi ng industr y-standard technolog ies. The p roject add s function ality to s oftware cu rrently in Productio n at the P hiladelphi a Informat ion Techno logy Cente r (PITC). The softwa re changes contained in this R SD are min imal chang es to an e xisting St ructured Q uery Langu age (SQL) Server dat abase. The requireme nt specifi cations in this docu ment will be made wi th the int ent to ser ve as a mu ltipurpose tool for the ORD Ce ntral Offi ce and the VAMC fiel d research offices. | |
269 | The follow ing archit ectural de sign const raints for the solut ions inclu de technic al constra ints, stan dards, non functional requireme nts, and i mportant a rchitectur al decisio ns. Listed below are currently identifie d design c onstraints per the “ new” requi rement, al ong with “ existing” design con straints f rom the in itial deve lopment. | |
270 | Memory Con straints a nd Databas e Requirem ents | |
271 | Additional data prod uced by th e IACUC, S afety, and R&D commi ttees will require a n increase d data sto rage requi rement. Ch anges to t he databas e structur e will be minimal be cause link s to the n ew feature s were ant icipated i n the orig inal datab ase design . | |
272 | Dependenci es and Con straints | |
273 | Successful implement ation of t his projec t requires adequate training a nd educati on for end Users and support s taff. | |
274 | All new fu nctionalit y to the a pplication /system is subject t o funds av ailability . | |
275 | Constraint s | |
276 | Providing secure acc ess in a r eal-time m ode will b e a major constraint . The syst em must se rve Users who are lo cated at V A affiliat es and uni versities. | |
277 | ||
278 | Additional Identifie d Design C onstraints : | |
279 | The system shall com ply with a ll VA Ente rprise Arc hitecture Standards | |
280 | The system shall be designed a s a Servic e Oriented Architect ure (SOA), as define d in “Prin ciples of Service Or iented Arc hitecture Version 1. 31, Softwa re Enginee ring – Sta ndards Div ision, Off ice of Ent erprise De velopment, Office of Informati on & Techn ology, Dep artment of Veterans Affairs.” | |
281 | Software i nterfaces built for new busine ss functio ns, legacy applicati ons, datab ases, midd leware, an d other in frastructu re compone nts shall be impleme nted as se rvices usi ng Simple Object Acc ess Protoc ol (SOAP)/ Hypertext Transfer P rotocol (H TTP(S)), E xtensible Markup Lan guage (XML )/HTTP(S), SOAP/Java Message S ervice (JM S), or XML /JMS. | |
282 | Services s hall be bu ilt using standards that promo te interop erability. [5] | |
283 | Services s hall be de signed acc ording to a technica l service contract a nd a negot iated Serv ice Level Agreement (SLA), whi ch togethe r comprise the servi ce contrac t. | |
284 | Services i mplementat ion shall be loosely coupled t o the serv ice interf ace. | |
285 | A service interface is the sol e entry po int into s ervice log ic and res ources. | |
286 | Services s hall be ac cessed onl y via the exposed, p ublished i nterfaces. | |
287 | All servic e interfac es shall b e defined using a te chnical se rvice cont ract that includes a WSDL (Web Services Descriptio n Language ) definiti on, one or more XML schema def initions, and Web Se rvices (WS )-Policy d efinitions , as requi red. | |
288 | Services s hall be de signed so they can b e monitore d to deter mine wheth er service s become u navailable , have a d etectable security f ault, and whether fa ctors spec ified in t he SLA por tion of th e Service Contract a re out of the permit ted range, including , but not limited to , resource utilizati on and the fault beh aviors and performan ce metrics . | |
289 | No service shall use static (e .g., hard- coded) ser vice addre sses. | |
290 | Service lo gic expose d by the s ervice sha ll handle concurrent access wi thout dead lock or lo ss of data integrity . | |
291 | Services s hall be im plemented in a manne r that doe s not requ ire consum ers to use a specifi c language (e.g., Ja va only) t o access t he service . | |
292 | Services, in the eve nt of exce ptions, sh all provid e fault co ntent to t he consume r and the audit log, without c ompromisin g security , which sh all includ e sufficie nt informa tion for c onsumer re covery. | |
293 | The System shall use Represent ational St ate Transf er (RESTfu l) Web ser vices for any servic e that is accessed t hrough the User inte rface. | |
294 | ||
295 | ||
296 | ||
297 | ||
298 | ||
299 | ||
300 | The follow ing table lists the technology that will be utiliz ed with th e RAMS Int egration. | |
301 | Table 2: L ist of Tec hnologies | |
302 | Technology Name | |
303 | Microsoft Structured Query Lan guage (SQL ) Server 2 012 | |
304 | Microsoft SQL Server Reporting Services 2012 | |
305 | Microsoft SharePoint 2013 SP1 | |
306 | Microsoft Windows Se rver 2008 R2/2012 | |
307 | Red Hat En terprise L inux 7.0.5 7 | |
308 | SQL Server Integrati on Service s 2012 | |
309 | The open-s ource soft ware appli cation tha t is utili zed is: | |
310 | Apache Tom cat 7.x (L atest Stab le) | |
311 | The Softwa re Develop ment frame work and p latform ut ilized is: | |
312 | Java Enter prise Edit ion 7 | |
313 | In additio n, the lis t comprise s the foll owing appl ications t he VA uses in suppor t of perfo rming proj ect develo pment proc esses: | |
314 | Rational T ool Set | |
315 | Microsoft (MS) Visua l Studio 2 010 | |
316 | The standa rds that a pply to th is design document, at a minim um, includ e: | |
317 | VA Handboo k 6500.3 C ertificati on & Accre ditation | |
318 | VA Handboo k 6102 Int ernet/Intr anet Servi ces | |
319 | Disaster R ecovery Sp ecificatio n | |
320 | RAMS is a n operatio nal enviro nment host ed at the PITC, ther efore the RAMS appli cation’s s ystems (su b-systems, component s, and dat abases) wi ll inherit the PITC’ s Disaster Recovery Plan (DRP) , a relate d Continge ncy Plan ( CP), and a n Incident Response Plan (IRP) . In the e vent that there is a n outage a nd the RAM S applicat ion system goes offl ine, the f ollowing i s required : | |
321 | The system should be fully res tored with in seventy -two (72) hours of a n outage. | |
322 | After an o utage, 99% of the da ta will ne ed to be r estored. | |
323 | Fail-over capabiliti es will be obtained by establi shing a si milar envi ronment at an altern ate data c enter and synchroniz ing the tr ansactions as they o ccur, with the exact method th at was det ermined in the PITC’ s DRP. | |
324 | Documentat ion Specif ications | |
325 | Requiremen ts for doc umentation , includin g training , User doc umentation , help sys tems, help about not ices, inst allation g uide, secu rity guide , implemen tation gui de, and an y other fo rms of doc umentation are provi ded below. The RAMS Integratio n will inc lude all o f the requ ired compo nents nece ssary to c onform to the docume ntation re quirements mandated by PMAS an d ProPath. | |
326 | Documentat ion will p otentially include, but is not limited t o, the fol lowing: | |
327 | Standard O perating P rocedures | |
328 | Change Man agement Pr ocess | |
329 | User manua l for soft ware: | |
330 | Updates sh all be mad e, as nece ssary, to applicable User manu als and ot her traini ng tools a nd shall b e delivere d to all l evels of U sers. If n o User doc umentation exists, i t shall be produced. | |
331 | Technical documentat ion | |
332 | Maintenanc e agreemen ts/documen tation: | |
333 | IT will pr ovide the level of d ocumentati on require d to suppo rt the sys tem and ma intain ope rations an d continui ty. Docume ntation sh all repres ent minima l programm atic and l ifecycle o perations support do cumentatio n artifact s, as defi ned by VA standards in ProPath and as re quired by the VA Ent erprise Sy stem Engin eering Lif ecycle and Release M anagement Office for sustained operation s, mainten ance, and support pr ior to app roval by a ny VA chan ge control board and release i nto produc tion. | |
334 | Implementa tion Guide | |
335 | A technica l training curriculu m shall be developed and deliv ered to al l levels o f staff Us ers: | |
336 | The traini ng curricu lum shall state the expected t raining ti me for pri mary Users and secon dary Users to become productiv e at using system. | |
337 | All traini ng curricu la, User m anuals, an d other tr aining too ls shall b e updated by proper authoritie s and deli vered to a ll levels of Users i n advance of deploym ent. The c urricula s hall inclu de all asp ects of th e applicat ion(s) and all chang es to proc esses and procedures . | |
338 | The traini ng curricu lum shall state the expected t ask comple tion time for primar y and seco ndary User s. | |
339 | Technical Help Desk support fo r the appl ication sh all be pro vided to U sers. | |
340 | Functional Specifica tions | |
341 | The Epics and User S tories doc umented in this sect ion repres ent the an alysis con ducted to date. It i s intended to be exh austive an d reflect all desire d requirem ents for t he RAMS In tegration. | |
342 | The format of these User Stori es is a st andard one , with the “As a…” c olumn on t he left, i ndicating who the ac tor(s) is/ are; the “ I want…” c olumn indi cating wha t action t hey wish t o take; an d the “So that…” col umn, indic ating the resulting outcome an d/or benef its. The f inal colum n, “Accept ance Crite ria/User S tory Notes ” provides more spec ifics abou t what wil l take pla ce in a gi ven User s tory, alon g with any business rules that must be a dhered to, or genera l notes th at must be considere d. This co lumn also includes q uestions f or VA pers onnel to a ddress at some point in the fu ture. | |
343 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for Bu siness Nee d (BN)1/El aboration Business R equirement 4. | |
344 | Table 3: E pic BN1 | |
345 | Epic BN1: Utilize na tionally s tandardize d terminol ogy in all fields in the RAMS system fro m authorit ative sour ces where available. | |
346 | ID | |
347 | Priority | |
348 | As a… | |
349 | I want… | |
350 | So that… | |
351 | Acceptance Criteria/ User Story Notes | |
352 | BN1 | |
353 | High | |
354 | RAMS User | |
355 | To be able to query the databa se using s tandardize d terminol ogy (for d ata elemen ts). | |
356 | I have the ability t o successf ully query the datab ase using standardiz ed technol ogy. | |
357 | To be able to query the databa se using s tandardize d technolo gy. | |
358 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 2/Elaborat ion Busine ss Require ment 5. | |
359 | Table 4: E pic BN2 | |
360 | Epic BN2: Enhance th e RAMS app lication t o allow si tes to tra ck and man age resear ch project s and stud ies. | |
361 | ID | |
362 | Priority | |
363 | As a… | |
364 | I want… | |
365 | So that… | |
366 | Acceptance Criteria/ User Story Notes | |
367 | BN2.1.2 | |
368 | High | |
369 | Principal Investigat or (PI) or PI Design ee | |
370 | To enter, edit, and attach doc uments to IACUC proj ects in da tabase. | |
371 | I have the ability t o initiate an IACUC applicatio n for a ne w study. T his includ es enterin g all data (pertinen t and impe rtinent) i n the RAMS database. | |
372 | I have the ability t o initiate review of a new stu dy in orde r to recei ve feedbac k prior to IACUC sub mission. | |
373 | To be able to enter, edit, and attach do cuments to IACUC pro jects in d atabase. | |
374 | ||
375 | NOTE: PI o r PI Desig nee can su bmit study applicati on for rev iew and co mplete edi ts based o n feedback . | |
376 | BN2.2.2 | |
377 | High | |
378 | Local Syst em Adminis trator (LS A)andAdmin istrative Officer (A O) | |
379 | To add Use rs and set permissio ns for IAC UC, R&D, S afety, and Research Compliance Officer ( RCO). | |
380 | And | |
381 | Add Users and set pe rmissions for IACUC, R&D, Safe ty, and RC O | |
382 | I have the ability t o add IACU C Users to the syste m. | |
383 | I have the ability t o assign I ACUC Users access pe rmissions. | |
384 | I have the ability t o add R&D Users to t he system. | |
385 | I have the ability t o add R&D Users acce ss permiss ions. | |
386 | I have the ability t o add Safe ty Users t o the syst em. | |
387 | I have the ability t o assign S afety User s access p ermissions . | |
388 | I have the ability t o add RCO Users to t he system. | |
389 | I have the ability t o assign R CO Users a ccess perm issions. | |
390 | I have the ability t o ensure t hat access to studie s is restr icted to a uthorized Users. | |
391 | I have the ability t o ensure t hat access to IACUC data is re stricted t o authoriz ed Users. | |
392 | To be able to add Us ers and se t permissi ons for IA CUC, R&D, Safety, an d RCO. | |
393 | ||
394 | NOTE: Unau thorized U sers are n ot permitt ed to acce ss or edit study dat a. | |
395 | ||
396 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
397 | 2.3 | |
398 | High | |
399 | RAMS Usera ndAdminist rative Off icer | |
400 | To print c omplete ap plication with all s ections in one docum ent R&D, S afety, and IACUC com mittees. | |
401 | I have the ability t o search f or key wor ds in the R&D commit tee. | |
402 | I have the ability t o search i n order to identify studies pe rtaining t o specific topics in the R&D c ommittee. | |
403 | I have the ability t o search f or key wor ds in the Safety com mittee. | |
404 | I have the ability t o search i n order to identify studies pe rtaining t o specific topics in the Safet y committe e. | |
405 | I have the ability t o search f or key wor ds in the IACUC comm ittee. | |
406 | I have the ability t o search i n order to identify studies pe rtaining t o specific topics in the IACUC committee . | |
407 | ||
408 | To be able to print complete a pplication with all sections i n one docu ment. | |
409 | ||
410 | Note: Ente ring a ter m in the s earch box produces a list of s tudies tha t have tha t term inc luded in a bstract. | |
411 | ||
412 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
413 | 2.4 | |
414 | High | |
415 | Administra tive Offic er andPrin cipal Inve stigator o r PI Desig nee | |
416 | To manage investigat ors and pe rsonnel re lated to r esearch pr ojects in the R&D, S afety, and IACUC com mittees. | |
417 | I have the ability t o manage i nvestigato rs and per sonnel rel ated to re search pro jects in t he R&D com mittee. | |
418 | I have the ability t o manage i nvestigato rs and per sonnel rel ated to re search pro jects in t he Safety committee. | |
419 | I have the ability t o manage i nvestigato rs and per sonnel rel ated to re search pro jects in t he IACUC c ommittee. | |
420 | To be able to manage investiga tors and p ersonnel r elated to research p rojects. | |
421 | ||
422 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
423 | 2.4.2 | |
424 | High | |
425 | Administra tive Offic er andPrin cipal Inve stigator o r PI Desig nee | |
426 | To manage investigat ors and pe rsonnel re lated to R &D, Safety , and IACU C research projects. | |
427 | I have the ability t o track wh ich person nel are as signed to specific s tudies in the R&D co mmittees. | |
428 | I have the ability t o ensure t hat person nel assign ed to rese arch studi es are qua lified per regulatio ns in the R&D commit tees. | |
429 | I have the ability t o track wh ich person nel are as signed to specific s tudies in the Safety committee s. | |
430 | I have the ability t o ensure t hat person nel assign ed to rese arch studi es are qua lified per regulatio ns in the Safety com mittees . | |
431 | I have the ability t o track wh ich person nel are as signed to specific s tudies in the IACUC committees . | |
432 | I have the ability t o ensure t hat person nel assign ed to rese arch studi es are qua lified per regulatio ns in the IACUC comm ittees.. | |
433 | To be able to manage investiga tors and p ersonnel r elated to IACUC rese arch proje cts. | |
434 | ||
435 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
436 | 2.5 | |
437 | High | |
438 | Principal Investigat or or PI D esignee | |
439 | To support auto fill reports a nd forms r equired by R&D, Safe ty, IACUC and subcom mittees. | |
440 | I have the ability t o complete various f orms requi red for an IRB appli cation. | |
441 | I have the ability t o be promp ted when a form is r equired to complete the form o nline in t he IRB com mittee app lication. | |
442 | I have the ability t o complete various f orms requi red for an R&D appli cation. | |
443 | I have the ability t o be promp ted when a form is r equired to complete the form o nline in t he R&D com mittee app lication. | |
444 | I have the ability t o complete various f orms requi red for an Safety ap plication. | |
445 | I have the ability t o be promp ted when a form is r equired to complete the form o nline in t he Safety committee applicatio n. | |
446 | I have the ability t o complete various f orms requi red for an IACUC app lication. | |
447 | I have the ability t o be promp ted when a form is r equired to complete the form o nline in t he IACUC c ommittee a pplication . | |
448 | ||
449 | Support au tofill rep orts and f orms requi red by R&D and subco mmittees. | |
450 | ||
451 | Note: Syst em calcula tes which forms are required a nd provide s links to complete form onlin e. | |
452 | ||
453 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
454 | 2.6 | |
455 | High | |
456 | Principal Investigat or or PI D esignee | |
457 | To attach review com mittee for ms, includ ing data s ecurity, C onflict of Interest (COI), saf ety, radia tion and I RB, R&D, S afety, or IACUC form s to proje ct. Tag up loaded for ms by type , date, an d author. | |
458 | I have the ability t o digitall y attach r eview comm ittee form s to an IR B study ap plication. | |
459 | I have the ability t o tag uplo aded IRB r eview comm ittee form s by type. | |
460 | I have the ability t o upload r eview IRB committee forms by d ate. | |
461 | I have the ability t o upload r eview IRB committee forms by a uthor. | |
462 | ||
463 | I have the ability t o digitall y attach r eview comm ittee form s to a R&D study app lication. | |
464 | I have the ability t o tag uplo aded R&D r eview comm ittee form s by type. | |
465 | I have the ability t o upload r eview R&D committee forms by d ate. | |
466 | I have the ability t o upload r eview R&D committee forms by a uthor. | |
467 | ||
468 | I have the ability t o digitall y attach r eview comm ittee form s to a Saf ety study applicatio n. | |
469 | ||
470 | ||
471 | Attach rev iew commit tee forms, including data secu rity, Conf lict of In terest (CO I), safety , radiatio n and IRB, R&D, Safe ty or IACU C forms to project. Tag upload ed forms b y type, da te, and au thor. | |
472 | ||
473 | ||
474 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
475 | ||
476 | ||
477 | ||
478 | ||
479 | I have the ability t o tag uplo aded revie w Safety c ommittee f orms by ty pe. | |
480 | I have the ability t o upload | |
481 | review Saf ety commit tee forms by date. | |
482 | I have the ability t o upload r eview Safe ty committ ee forms b y author. | |
483 | ||
484 | I have the ability t o | |
485 | digitally attach rev iew | |
486 | committee forms to a n IACUC s tudy appli cation. | |
487 | I have the ability t o tag uplo aded revie w IACUC | |
488 | committee forms by t ype. | |
489 | I have the ability t o upload | |
490 | review IAC UC committ ee forms b y date. | |
491 | I have the ability t o upload r eview IAC UC committ ee formsby author. | |
492 | ||
493 | 2.7 | |
494 | Medium | |
495 | Principal Investigat or or PI D esignee | |
496 | To submit and track eligibilit y and off- site waive rs in the IRB, R&D, Safety, an d IACUC co mmittees. | |
497 | I have the ability t o submit a request f or an off- site waive r in the I RB committ ee applica tion. | |
498 | I have the ability t o understa nd the rul es for an off-site w aiver in t he IRB com mittee app lication. | |
499 | I have the ability t o receive a ruling a fter a req uest has b een made f or the wai ver in the IRB commi ttee appli cation. | |
500 | ||
501 | I have the ability t o submit a request f or an off- site waive r in the R &D applic ation. com mittee | |
502 | I have the ability t o understa nd the rul es for an off-site w aiver in t he R&D com mittee app lication. | |
503 | I have the ability t o receive a ruling a fter a req uest has b een made f or the wai ver in the R&D commi ttee appl ication. | |
504 | ||
505 | I have the ability t o submit a request f or an off- site waive r in the S afety comm ittee appl ication. | |
506 | . | |
507 | ||
508 | To be able to submit and track eligibili ty and off -site waiv ers. | |
509 | ||
510 | NOTE: Syst em accepts waiver re quest and notifies I RB Coordin ator. Syst em tracks status of the reques t. (for IR B only) | |
511 | ||
512 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
513 | ||
514 | ||
515 | ||
516 | ||
517 | I have the ability t o understa nd the rul es | |
518 | for an off -site waiv er in the Safety com mittee app lication. | |
519 | I have the ability t o | |
520 | receive a ruling aft er a | |
521 | request ha s been mad e | |
522 | for the wa iver in th e Safety c ommittee a pplication . | |
523 | ||
524 | I have the ability t o submit a request f or an off- site | |
525 | waiver in the IACUC committee applicatio n. | |
526 | I have the ability t o u for an off-site waiver in the IACUC committee applicatio n. . | |
527 | I have the ability t o understa nd the rul es | |
528 | receive a ruling aft er a reque st has bee n made for the waive r in the I ACUC commi ttee appli cation. | |
529 | ||
530 | 2.9 | |
531 | High | |
532 | Administra tive Offic erandAssoc iate Chief of Staff for Resear ch | |
533 | To track s ponsorship and fundi ng status for projec ts in the R&D, Safet y, and IAC UC committ ees. | |
534 | I have the ability t o track th e sponsors hip for ea ch project in the R& D committe es.I have the abilit y to track current f unding sta tus for ea ch project in the R& D committe es. I have the abili ty to know the curre nt funding status fo r each pro ject in or der to ale rt PIs whe n expendit ures excee d obligate d funds in the R&D c ommittees. | |
535 | ||
536 | I have the ability t o track th e sponsors hip for ea ch project in the Sa fety commi ttees. | |
537 | I have the ability t o track cu rrent fund ing status for each project in the Safet y committe es. | |
538 | I have the ability t o know the current f unding sta tus for ea ch project in order to alert P Is when ex penditures exceed ob ligated fu nds in the Safety co mmittees. | |
539 | ||
540 | I have the ability t o track th e sponsors hip for ea ch | |
541 | ||
542 | To be able to track sponsorshi p and fund ing status for proje cts. | |
543 | Note: AO c an select Funding St atus Repor t and view funding s tatus for each proje ct by spon sor. | |
544 | ||
545 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
546 | ||
547 | ||
548 | ||
549 | ||
550 | project in the IACUC committee s. | |
551 | I have the ability t o track cu rrent fund ing status for each project in the IACUC committee s. | |
552 | I have the ability t o know the current f unding sta tus for ea ch project in order to alert P Is when ex penditures exceed ob ligated fu nds in the IACUC com mittees. | |
553 | ||
554 | 2.10.2 | |
555 | High | |
556 | Principal Investigat or or PI D esignee | |
557 | To submit all R&D, S afety, and IACUC pro gress repo rts and re views. | |
558 | I have the ability t o submit a n annual r eport elec tronically for R&D c ommittees. | |
559 | When neede d, I have the abilit y to submi t a tri-an nual revie w for R&D committees . | |
560 | When neede d, I have the abilit y to submi t an ad-ho c review f or R&D com mittees. | |
561 | I have the ability t o be notif ied when a n annual r eport is d ue for R&D committee s. | |
562 | I have the ability t o be notif ied when a n annual r eport has the capabi lity to fi le the rep ort online for R&D c ommittees. | |
563 | ||
564 | I have the ability t o submit a n annual r eport elec tronically for Safet y committe es. | |
565 | When neede d, I have the abilit y to submi t a tri-an nual revie w for Safe ty committ ees. | |
566 | ||
567 | To be able to submit Annual or Final (or as needed ) R&D, Saf ety, and I ACUC Proje ct Reports . | |
568 | ||
569 | NOTE: PI o r PI Desig nee is not ified 90 d ays before Annual Re port is du e and can complete t he report using onli ne forms. | |
570 | ||
571 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
572 | ||
573 | ||
574 | ||
575 | ||
576 | When neede d, I have the abilit y to submi t an ad-ho c review f or the Saf ety commit tees. | |
577 | I have the ability t o be notif ied when a n annual r eport is d ue for the Safety co mmittees. | |
578 | I have the ability t o be notif ied when a n annual r eport has the capabi lity to fi le the rep ort online for the S afety comm ittees. | |
579 | ||
580 | I have the ability t o submit a n annual r eport elec tronically for the I ACUC commi ttees. | |
581 | When neede d, I have the abilit y to submi t a tri-an nual revie w for the IACUC comm ittees. | |
582 | When neede d, I have the abilit y to submi t an ad-ho c review f or the IAC UC committ ees. | |
583 | I have the ability t o be notif ied when a n annual r eport is d ue for the IACUC com mittees. | |
584 | I have the ability t o be notif ied when a n annual r eport has the capabi lity to fi le the rep ort online for the I ACUC commi ttees. | |
585 | ||
586 | 2.11 | |
587 | Low | |
588 | Principal Investigat or or PI D esignee | |
589 | To track p ublication s and awar ds with pr oject data within th e R&D, Saf ety, and I ACUC appli cations. | |
590 | I have the ability t o add publ ications t o the Bios ketch. | |
591 | I have the ability t o add awar ds to the Biosketch. | |
592 | I have the ability t o keep the Biosketch up to dat e. | |
593 | I have the ability t o create t ailored ve rsions for particula r IRB appl ications. | |
594 | ||
595 | I have the ability t o add publ ications t o the Bios ketch in t he R&D com mittee app lication.. | |
596 | I have the ability t o add awar ds to the Biosketch in the R&D committee applicati on. | |
597 | I have the ability t o keep the Biosketch up to dat e in the R &D committ ee applica tion.. | |
598 | I have the ability t o create t ailored ve rsions for particula r R&D appl ications. | |
599 | ||
600 | I have th e ability to add pub lications to the Bio sketch in the Safety committee applicati on. | |
601 | ||
602 | To be able to track publicatio ns and awa rds with p roject dat a. | |
603 | ||
604 | NOTE: PI o r PI Desig nee can re view and e dit Bioske tch online including publicati ons and aw ards secti on. | |
605 | ||
606 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
607 | A change r equest may be in ord er to incl ude the IR B at a lat er date. | |
608 | ||
609 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 3 / Elabor ation Busi ness Requi rement 6. | |
610 | Table 5: E pic BN3 | |
611 | Epic BN3: Enhance th e RAMS app lication t o automate the manag ement of c ommittees to ensure compliance . | |
612 | ID | |
613 | Priority | |
614 | As a… | |
615 | I want… | |
616 | So that… | |
617 | Acceptance Criteria/ User Story Notes | |
618 | ||
619 | ||
620 | ||
621 | ||
622 | I have the ability t o add awar ds to the Biosketch | |
623 | in the Saf ety commit tee applic ation. | |
624 | I have the ability t o keep the Biosketch up to dat e in the S afety comm ittee appl ication. | |
625 | I have the ability t o create t ailored ve rsions for particula r Safety a pplication s. | |
626 | ||
627 | I have the ability t o add publ ications t o the Bios ketch in t he IACUC c ommittee a pplication . | |
628 | I have th e ability to add awa rds to the Biosketch | |
629 | in the IAC UC committ ee applica tion. | |
630 | I have the ability t o keep the Biosketch up to dat e in the I ACUC commi ttee appli cation. | |
631 | I have the ability t o create t ailored ve rsions for particula r IACUC ap plications . | |
632 | ||
633 | 3.1/6.1 | |
634 | High | |
635 | Site Syste m Administ rator (SSA ) | |
636 | To add or delete R&D , Safety, and IACUC committees based on site Stand ard Operat ing Proced ure (SOP). | |
637 | ||
638 | NOTE: An o ption to a dd, delete , or confi gure commi ttees is a vailable o n the Syst em Adminis trator (SA ) tool pag e. | |
639 | I have the ability t o configur e RAMS to match the R&D commit tee roster at my sit e.I have t he ability to add R& D committe es that ar e not RAMS ’s default s.I have t he ability to hide R &D committ ees that a re not use d at my si te. | |
640 | ||
641 | I have the ability t o configur e RAMS to match the Safety com mittee ros ter at my site. | |
642 | I have the ability t o add Safe ty commit tees that are not RA MS’s defau lts. | |
643 | I have the ability t o hide Saf ety commi ttees that are not u sed at my site. | |
644 | ||
645 | I have the ability t o configur e RAMS to match the IACUC comm ittee rost er at my s ite. | |
646 | I have the ability t o add IACU C committe es that ar e not RAMS ’s default s. | |
647 | I have the ability t o hide IAC UC committ ees that a re not use d at my si te. | |
648 | NOTE: An o ption to a dd, delete or config ure commit tees is av ailable on the SA to ol page. | |
649 | The SSA is able to a dd or dele te committ ees based on the sit e SOP. | |
650 | ||
651 | NOTES: | |
652 | An option to add, de lete or co nfigure co mmittees i s availabl e on the S A tool pag e. | |
653 | ||
654 | Currently there is n o RAMS def ault commi ttee. The goal is to have some what of a default co mmittee bu t also hav e the abil ity to cus tomize eac h site. | |
655 | ||
656 | RAMS is an enterpris e like pro ject, but neither on e on the R AMS projec ts are con figuring a ny special committee . | |
657 | ||
658 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
659 | 3.2/6.2 | |
660 | High | |
661 | Committee Coordinato r | |
662 | To add mem bers to R& D, Safety, and IACUC committee s, track m eeting att endance, a nd track a ppointment dates. | |
663 | I have the ability t o add memb ers to R&D committee s. | |
664 | I have the ability t o track R& D committe e meeting attendance . | |
665 | I have the ability t o track R& D committe e appointm ent dates. | |
666 | ||
667 | I have the ability t o add memb ers to Saf ety commit tees. | |
668 | I have the ability t o track Sa fety commi ttee meeti ng attenda nce. | |
669 | I have the ability t o track Sa fety commi ttee appoi ntment dat es. | |
670 | ||
671 | I have the ability t o add memb ers to IAC UC committ ees. | |
672 | I have the ability t o track IA CUC commit tee meetin g attendan ce. | |
673 | I have the ability t o track IA CUC commit tee appoin tment date s. | |
674 | Add member s to commi ttees and track appo intment da tes. | |
675 | ||
676 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
677 | 3.2.2/6.2. 1 | |
678 | High | |
679 | Committee Coordinato r | |
680 | To add mem bers to co mmittees, track meet ing attend ance, and track appo intment da tes – IACU C, Safety, and R&D | |
681 | I have the ability t o manage t he IACUC c ommittee r oster. | |
682 | I have the ability t o manage m y Safety c ommittee r oster. | |
683 | I have the ability t o manage t he R&D com mittee ros ter. | |
684 | I have the ability t o monitor IACUC comm ittee memb er availab ility in o rder to en sure that a quorum i s availabl e at each meeting. | |
685 | I have the ability t o track IA CUC commit tee member ’s appoint ment dates in order to ensure that a quo rum is ava ilable at each meeti ng. | |
686 | I have the ability t o obtain I ACUC commi ttee membe r’s qualif ications i n order to ensure th at a quoru m is avail able at ea ch meeting . | |
687 | I have the ability t o monitor Safety com mittee mem bers in or der to ens ure that a quorum is available at each m eeting. | |
688 | I have the ability t o track Sa fety commi ttee membe r availabi lity in or der to ens ure that a quorum is available at each m eeting. | |
689 | I have the ability t o track Sa fety commi ttee membe r’s appoin tment date s in order to ensure that a qu orum is av ailable at each meet ing. | |
690 | I have the ability t o obtain S afety comm ittee memb er’s quali fications in order t o ensure t hat a quor um is avai lable at e ach meetin g. | |
691 | I have the ability t o monitor R&D commit tee member availabil ity in ord er to ensu re that a quorum is available at each me eting. | |
692 | I am able to track R &D committ ee members in order to ensure that a quo rum is ava ilable at each meeti ng. | |
693 | I have the ability t o track R& D committe e member’s appointme nt dates i n order to ensure th at a quoru m is avail able at ea ch meeting . | |
694 | The Commit tee Coordi nator is a ble to add members t o committe es and tra ck appoint ment dates – IACUC, Safety, an d R&D. | |
695 | NOTES: | |
696 | The commit tee roster tool is u sed to ide ntify the Chair Pers on and the members o f the comm ittee, as well as de signated a lternates. | |
697 | The number of quorum members a nd the mak eup of the qualifica tions of t he quorum members ar e governed and local ly managed and the c ommittee a ctions are locally d efined. | |
698 | See VHA Ha ndbook 120 0, VHA Han dbook 1200 .05 and VH A Handbook 1200.1 fo r more det ails. | |
699 | Committee Management entails: | |
700 | Defining m embers. | |
701 | Creating a gendas. | |
702 | Scheduling meetings. | |
703 | Creating m inutes. | |
704 | Posting me etings. | |
705 | Creating t asks. | |
706 | Assigning tasks. | |
707 | Tracking t asks until completio n. | |
708 | Keeping a library of important committee documents , communic ations ann ouncements , lists, c ommittee k nowledge b ase and UR L links. | |
709 | ||
710 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
711 | 3.3/6.3 | |
712 | High | |
713 | Committee Coordinato r | |
714 | Add projec ts, amendm ents, and other busi ness to R& D, Safety, and IACUC committee agenda. | |
715 | I have the ability t o add proj ects R&D c ommittee a genda. | |
716 | I have the ability t o add amen dments R&D committee agenda. | |
717 | I have the ability t o add othe r business to R&D co mmittee ag enda. | |
718 | ||
719 | I have the ability t o add proj ects Safet y committe e agenda. | |
720 | I have the ability t o add amen dments Saf ety commit tee agenda . | |
721 | I have the ability t o add othe r business to Safety committee agenda. | |
722 | ||
723 | I have the ability t o add proj ects IACUC committee agenda. | |
724 | I have the ability t o add amen dments IAC UC committ ee agenda. | |
725 | I have the ability t o add othe r business to IACUC committee agenda. | |
726 | Add projec ts, amendm ents, and other busi ness to co mmittee ag enda. | |
727 | ||
728 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
729 | 3.3.2/6.3. 1 | |
730 | High | |
731 | Committee Coordinato r | |
732 | To add and control t he version s of proje cts, amend ments, and other bus iness to c ommittee a genda – IA CUC, Safet y, and R&D . | |
733 | I have the ability t o create t he agenda for each R &D committ ee meeting .I have th e ability to set the meeting s chedule fo r each R&D committee meeting.I have the ability to maintain the agenda for each R&D commit tee meetin g.I have t he ability to mainta in an elec tronic ver sion of th e R&D comm ittee meet ing agenda in order to allow m embers to review age nda items. | |
734 | ||
735 | I have the ability t o create t he agenda for each S afety comm ittee meet ing. | |
736 | I have the ability t o set the meeting sc hedule for each Safe ty committ ee meeting . | |
737 | I have the ability t o maintain the agend a for each Safety co mmittee me eting. | |
738 | I have the ability t o maintain an electr onic versi on of the Safety com mittee mee ting agend a in order to allow members to review ag enda items . | |
739 | ||
740 | ||
741 | The Commit tee Coordi nator is a ble to add projects, amendment s, and oth er busines s to commi ttee agend a – IACUC, Safety, a nd R&D. | |
742 | ||
743 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
744 | ||
745 | ||
746 | ||
747 | ||
748 | I have the ability t o create t he agenda for each I ACUC commi ttee meeti ng. | |
749 | I have the ability t o set the meeting sc hedule for each IACU C committe e meeting. | |
750 | I have the ability t o maintain the agend a for each IACUC com mittee mee ting. | |
751 | I have the ability t o maintain an electr onic versi on of the IACUC comm ittee meet ing agenda in order to allow m embers to review age nda items. | |
752 | ||
753 | 3.3.3/6.3. 2 | |
754 | Medium | |
755 | Committee Coordinato r | |
756 | To revise agenda tem plate for R&D, Safet y, and IAC UC. | |
757 | I have the ability t o revise t he agenda template f or R&D com mittees.I have the a bility to update the template for R&D co mmittees. | |
758 | ||
759 | I have the ability t o revise t he agenda template f or Safety committees . | |
760 | I have the ability t o update t he templat e for Safe ty committ ees. | |
761 | ||
762 | I have the ability t o revise t he agenda template f or IACUC c ommittees. | |
763 | I have the ability t o update t he templat e for IACU C committe es. | |
764 | The Commit tee Coordi nator is a ble to rev ise the ag enda templ ate. Permi ssions sho uld be lim ited to no t allow ne w fields t o the agen da templat e. Potenti al revisio ns should be limited to drop d own lists to maintai n consiste ncy. | |
765 | ||
766 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
767 | 3.4/6.4 | |
768 | High | |
769 | Site Syste m Administ rator | |
770 | To provide portal/to ols for lo cal form c reation an d form-bas ed collect ion of saf ety inform ation for the R&D, S afety, and IACUC. | |
771 | I have the ability t o create a local ver sion of a safety inf ormation f orm for R& D committe e. I have the abilit y to incor porate the form into the RAMS workflow f or the R&D committee . I have t he ability to add cu stom forms to the RA MS R&D app lication. The form s hould be p rintable t o enable u pload and attachment to a stud y. | |
772 | SSA is abl e to acces s a portal / tools f or local f orm creati on and for m-based co llection o f safety i nformation .NOTE: The custom fo rms will b e added to the appli cation ele ctronicall y. | |
773 | ||
774 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
775 | ||
776 | ||
777 | ||
778 | ||
779 | I have the ability t o create a local ver sion of a safety inf ormation f orm for Sa fety commi ttee. | |
780 | I have the ability t o incorpor ate the fo rm into th e RAMS wor kflow for the Safety committee . | |
781 | I have the ability t o add cust om forms t o the RAMS Safety ap plication. The form should be printable to enable upload and attachmen t to a stu dy. | |
782 | ||
783 | I have the ability t o create a local ver sion of a safety inf ormation f orm for IA CUC commit tee. | |
784 | I have the ability t o incorpor ate the fo rm into th e RAMS wor kflow for the IACUC committee. | |
785 | I have the ability t o add cust om forms t o the RAMS IACUC app lication. The form s hould be p rintable t o enable u pload and attachment to a stud y. | |
786 | ||
787 | ||
788 | 3.5/6.5 | |
789 | High | |
790 | Principal Investigat or or PI D esignee | |
791 | To automat e creation of Animal Component of Resear ch Protoco l (ACORP) and other compliance forms. | |
792 | I have the ability t o create a new ACORP as a comp onent of a study inv olving ani mals.I hav e the abil ity to com plete the ACORP onli ne in orde r to exped ite the su bmission o f this for m to the I ACUC. | |
793 | The PI or PI Designe e is able to automat e the crea tion of AC ORP and ot her compli ance forms . | |
794 | 3.7/6.6 | |
795 | High | |
796 | Committee Coordinato rs | |
797 | Schedule m eetings an d notify m embersin t he R&D, Sa fety, and the IACUC committees . | |
798 | I have the ability t o schedule meetings in R&D com mittees. | |
799 | I have the ability t o notify m embers in the R&D co mmittees. | |
800 | I have the ability t o schedule meetings in Safety committees . | |
801 | I have the ability t o notify m embers in the Safety committee s. | |
802 | I have the ability t o schedule meetings in IACUC c ommittees. | |
803 | I have the ability t o notify m embers in the IACUC | |
804 | committee s. | |
805 | Schedule m eetings an d notify m embers. | |
806 | ||
807 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
808 | 3.8/6.7 | |
809 | High | |
810 | IRB Admini strator, S afety Comm ittee Admi nistrator, R&D Admin istrator, IACUC Admi nistrator | |
811 | Collect re viewer fee dbackfor R &D, Safety , and IACU C committe es. | |
812 | I have the ability t o collect reviewer f eedback fo r R&D comm ittees. | |
813 | I have the ability t o collect reviewer f eedback fo r Safety c ommittees. | |
814 | I have the ability t o collect reviewer f eedback fo r IACUC co mmittees. | |
815 | Collect re viewer fee dback. | |
816 | ||
817 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
818 | 3.8.2/6.7. 1 | |
819 | High | |
820 | IRB Admini strator | |
821 | To collect committee feedback – R&D, Saf ety, and I ACUC. | |
822 | I have the ability t o monitor R&D commit tee corres pondence.I have the ability to attach th e R&D corr espondence to the ap propriate study appl ication. | |
823 | ||
824 | I have the ability t o monitor Safety com mittee cor respondenc e. | |
825 | I have the ability t o attach t he Safety correspond ence to th e appropri ate study applicatio n. | |
826 | ||
827 | I have the ability t o monitor IACUC comm ittee corr espondence . | |
828 | I have the ability t o attach t he IACUC c orresponde nce to the appropria te study a pplication . | |
829 | Reviewer c omments sh ould be pa rt of the approval l etter. | |
830 | ||
831 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
832 | 3.8.2/6.7. 1 | |
833 | High | |
834 | Safety Com mittee Adm inistrator | |
835 | To collect reviewer feedback – IACUC, Sa fety, and R&D. | |
836 | I have the ability t o attach t he Safety reviewer c omments to the appro priate stu dy applica tion.I hav e the abil ity to mon itor Safet y reviewer comments in order t o forward requests f or changes or clarif ication to the PI or PI Design ee. | |
837 | The Safety Committee Administr ator is ab le to coll ect review er feedbac k –Safety. | |
838 | ||
839 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
840 | 3.8.2/6.7. 1 | |
841 | High | |
842 | R&D Admini strator | |
843 | To collect reviewer feedback – IACUC, Sa fety, and R&D. | |
844 | I have the ability t o monitor R&D review er comment s.I have t he ability to attach the R&D r eviewer co mments to the approp riate stud y applicat ion.I have the abili ty to moni tor R&D re viewer com ments in o rder to fo rward requ ests for c hanges or clarificat ion to the PI or PI Designee. | |
845 | The R&D Ad ministrato r is able to collect reviewer feedback – R&D. | |
846 | ||
847 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
848 | 3.8.2/6.7. 1 | |
849 | High | |
850 | IACUC Admi nistrator | |
851 | To collect reviewer feedback – IACUC, Sa fety, R&D. | |
852 | I have the ability t o monitor IACUC revi ewer comme nts in ord er to forw ard reques ts for cha nges or cl arificatio n to the P I or PI De signee. | |
853 | The IACUC is able to collect r eviewer fe edback – I ACUC. | |
854 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
855 | ||
856 | 3.8.3/6.7. 2 | |
857 | High | |
858 | IRB Admini strator | |
859 | To collect feedback from other subcommit tees – IRB , IACUC, S afety, and R&D. | |
860 | I have the ability t o monitor correspond ence from other subc ommittees | |
861 | The IRB Ad ministrato r is able to collect reviewer feedback f rom other subcommitt ees IRB, I ACUC, Safe ty, and R& D. | |
862 | ||
863 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
864 | 3.8.3/6.7. 2 | |
865 | High | |
866 | IACUC Admi nistrator | |
867 | To collect feedback from other subcommit tees – IRB , IACUC, S afety, and R&D. | |
868 | I have the ability t o monitor correspond ence from other subc ommittees. | |
869 | The IACUC Administra tor is abl e to colle ct feedbac k from oth er subcomm ittees – I RB, Safety , and R&D. | |
870 | ||
871 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
872 | 3.8.3/6.7. 2 | |
873 | High | |
874 | Safety Com mittee Adm inistrator | |
875 | To collect feedback from other subcommit tees – IRB , IACUC, S afety, and R&D. | |
876 | I have the ability t o monitor correspond ence from other subc ommittees. | |
877 | The Safety Committee Administr ator is ab le to coll ect feedba ck from ot her subcom mittees – IRB, IACUC , and R&D. | |
878 | ||
879 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
880 | 3.8.3/6.7. 2 | |
881 | High | |
882 | R&D Commit tee Admini strator | |
883 | To collect feedback from other subcommit tees – IRB , IACUC, S afety, and R&D. | |
884 | I have the ability t o monitor correspond ence from other subc ommittees. | |
885 | The R&D Co mmittee Ad ministrato r is able to collect feedback from other subcommit tees –IRB, IACUC, an d Safety. | |
886 | ||
887 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
888 | 3.9/6.8 | |
889 | High | |
890 | RAMS User | |
891 | To provide a mechani sm for the use of se cure elect ronic sign atures for the signi ng of all forms and correspond ence for R &D, Safety , and IACU C committe es. | |
892 | I have the ability t o sign doc uments ele ctronicall y as part of the stu dy applica tion.I hav e the abil ity to sig n document s electron ically as part of th e approval process.I have the ability to sign docu ments elec tronically to avoid printing o f paper do cuments.I have the a bility to sign docum ents elect ronically to avoid d istributio n of paper documents .I have th e ability to sign do cuments el ectronical ly to avoi d storage of paper d ocuments.N OTE: User can choose to sign e lectronica lly when s ubmitting a document that requ ires signa ture. | |
893 | Provide th e RAMS Use r with a m echanism f or the use of secure electroni c signatur es for the signing o f all form s and corr espondence . NOTE: Th e goal is to get the signature s electron ically man dated but not sure i f that wil l happen. | |
894 | ||
895 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
896 | 3.10/6.9 | |
897 | High | |
898 | Committee Coordinato r | |
899 | To publish , store, a nd upload draft and final vers ions of me eting minu tes for th e R&D, Saf ety, and I ACUC commi ttees. | |
900 | I have the ability t o publish meeting mi nutes for R&D commit tees. | |
901 | I have the ability t o | |
902 | store minu tes of mee tings for R&D commit tees. | |
903 | Publish an d store mi nutes of m eetings | |
904 | ||
905 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
906 | ||
907 | ||
908 | ||
909 | ||
910 | I have the ability t o upload d raft versi ons of mee ting minut es for the R&D commi ttees. | |
911 | I have the ability t o upload f inal versi ons of mee ting minut es for the R&D commi ttees. | |
912 | ||
913 | I have the ability t o publish meeting mi nutes for Safety com mittees. | |
914 | I have the ability t o | |
915 | store minu tes of mee tings for Safety com mittees. | |
916 | I have the ability t o upload d raft versi ons of mee ting minut es for the Safety co mmittees. | |
917 | I have the ability t o upload f inal versi ons of mee ting minut es for the Safety co mmittees. | |
918 | ||
919 | I have the ability t o publish meeting mi nutes for IACUC comm ittees. | |
920 | I have the ability t o | |
921 | store minu tes of mee tings for IACUC comm ittees.. | |
922 | I have the ability t o upload d raft versi ons of mee ting minut es for the IACUC com mittees. | |
923 | I have the ability t o upload f inal versi ons of mee ting minut es for the IACUC com mittees. | |
924 | ||
925 | 3.10.2/6.9 .1 | |
926 | High | |
927 | Committee Coordinato r | |
928 | To publish , store, a nd upload draft and final vers ions of me eting minu tes – IACU C, Safety, and R&D | |
929 | I have the ability t o create I ACUC minut es of meet ings. | |
930 | I have the ability t o edit IAC UC minutes of meetin gs. | |
931 | I have the ability t o archive IACUC minu tes of mee tings. | |
932 | I have the ability t o create S afety minu tes of mee tings. | |
933 | I have the ability t o edit Saf ety minute s of meeti ngs. | |
934 | I have the ability t o archive Safety min utes of me etings. | |
935 | I have the ability t o create R &D minutes of meetin gs. | |
936 | I have the ability t o edit R&D minutes o f meetings . | |
937 | I have the ability t o archive R&D minute s of meeti ngs | |
938 | I have the ability t o ensure t hat IACUC meeting mi nutes are available online to Users who have appro priate per missions. | |
939 | I have the ability t o ensure t hat IACUC meeting mi nutes are accessible to Users who have a ppropriate permissio ns. | |
940 | I have the ability t o ensure t hat Safety meeting m inutes are available online to Users who have appr opriate pe rmissions. | |
941 | I have the ability t o ensure t hat Safety meeting m inutes are accessibl e to Users who have appropriat e permissi ons. | |
942 | I have the ability t o ensure t hat R&D me eting minu tes are av ailable on line to Us ers who ha ve appropr iate permi ssions. | |
943 | I have the ability t o ensure t hat R&D me eting minu tes are ac cessible t o Users wh o have app ropriate p ermissions . | |
944 | The Commit tee Coordi nator is a ble to pub lish and s tore minut es of meet ings – IAC UC, Safety , and R&D. | |
945 | ||
946 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
947 | 3.10.3/6.9 .2 | |
948 | Medium | |
949 | IACUC Comm ittee Coor dinator | |
950 | To edit mi nutes form at | |
951 | I have the ability t o revise t he format of IACUC m eeting min utes. | |
952 | The IACUC Committee Coordinato r is able to revise the format of IACUC minutes fo rmat. | |
953 | 3.10.3/6.9 .2 | |
954 | Medium | |
955 | Safety Com mittee Coo rdinator | |
956 | To edit mi nutes form at | |
957 | I have the ability t o revise t he format of Safety meeting mi nutes. | |
958 | The Safety Committee Coordinat or is able to revise the forma t of Safet y minutes format. | |
959 | 3.10.3/6.9 .2 | |
960 | Medium | |
961 | R&D Commit tee Coordi nator | |
962 | To edit mi nutes form at | |
963 | I have the ability t o revise t he format of R&D mee ting minut es. | |
964 | The R&D Co mmittee Co ordinator is able to revise th e format o f R&D minu tes format . | |
965 | 3.12/6.10 | |
966 | High | |
967 | IACUC Admi nistrator, Safety Co mmittee Ad ministrato r and R&D Committee Administra tor | |
968 | Provide IA CUC, Safet y and R&D management Capabilit y | |
969 | I have the ability t o comply w ith Federa l and VA r egulations for R&D c ommittees. | |
970 | ||
971 | I have the ability t o comply w ith Federa l and VA r egulations for Safet y committe es. | |
972 | ||
973 | I have the ability t o comply w ith Federa l and VA r egulations for IACUC committee s. | |
974 | To adequat ely satisf y all Fede ral and VA regulatio ns governi ng the man agement of the R&D, Safety, an d IACUC co mmittees t o include computer u sage, stor age, and s ecurity. | |
975 | ||
976 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
977 | 3.12/6.10. 1 | |
978 | High | |
979 | IACUC Admi nistrator | |
980 | To be able to manage all aspec ts of his/ her IACUC committee to ensure compliance with Fede ral and VA regulatio ns. This i ncludes sc hedules, m eetings, n otificatio ns, minute s, and doc uments. | |
981 | I have the ability t o comply w ith Federa l and VA r egulations in the IA CUC commit tees. | |
982 | Provide ma nagement c apability - This inc ludes sche dules, mee tings, not ifications , minutes, and docum ents . | |
983 | 3.12/6.10. 1 | |
984 | High | |
985 | Safety Com mittee Adm inistrator | |
986 | To be able to manage all aspec ts of his/ her Safety committee to ensure complianc e with fed eral and V A regulati ons. This includes s chedules, meetings, notificati ons, minut es, and do cuments. | |
987 | I have the ability t o comply w ith Federa l and VA r egulations in the Sa fety commi ttees. | |
988 | Provide ma nagement c apability - This inc ludes sche dules, mee tings, not ifications , minutes, and docum ents . | |
989 | 3.12/6.10. 1 | |
990 | High | |
991 | R&D Commit tee Admini strator | |
992 | To be able to manage all aspec ts of his/ her R&D co mmittee to ensure co mpliance w ith federa l and VA r egulations . This inc ludes sche dules, mee tings, not ifications , minutes, and docum ents. | |
993 | I have the ability t o comply w ith Federa l and VA r egulations in the R& D committe es. | |
994 | Provide ma nagement c apability - This inc ludes sche dules, mee tings, not ifications , minutes, and docum ents. | |
995 | 3.13/6.11 | |
996 | High | |
997 | Committee Coordinato r | |
998 | To track r eporting o f adverse events, pr otocol dev iations, a nd protoco l exceptio ns in the R&D, Safet y, and IAC UC committ ees. | |
999 | I have the ability t o comply w ith Federa l review e vents subm itted from the PI or PI Design ee regardi ng adverse events, p rotocol de viations, and VA reg ulations i n the R&D committees . | |
1000 | ||
1001 | I have the ability t o comply w ith Federa l review e vents subm itted from the PI or PI Design ee regardi ng adverse events, p rotocol de viations, and VA reg ulations i n the Safe ty committ ees. | |
1002 | ||
1003 | ||
1004 | Track repo rting of a dverse eve nts, proto col deviat ions, and protocol e xceptions. | |
1005 | ||
1006 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1007 | ||
1008 | ||
1009 | ||
1010 | ||
1011 | I have the ability t o comply w ith Federa l review e vents subm itted from the PI or PI Design ee regardi ng adverse events, p rotocol de viations, and VA reg ulations i n the IACU C committe es. | |
1012 | ||
1013 | 3.13.2/6.1 1.1 | |
1014 | High | |
1015 | Committee Coordinato r | |
1016 | To track r eporting o f adverse events, pr otocol dev iations, a nd protoco l exceptio ns – IACUC ,IRB, SRS, and R&D. | |
1017 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in IRB com mittees.I have the a bility to coordinate notificat ion regard ing advers e events a nd protoco l deviatio ns in IRB committees .I have th e ability to maintai n records of adverse event doc uments for filing of required reportsin IRB commit tees.I hav e the abil ity to mai ntain reco rds of not ifications for filin g of requi red report s in IRB c ommittees. | |
1018 | ||
1019 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in IACUC c ommittees. | |
1020 | I have the ability t o coordina te notific ation rega rding adve rse events and proto col deviat ions in IA CUC commit tees.. | |
1021 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports in IACUC comm ittees.. | |
1022 | I have the ability t o maintain records o f notifica tions for filing of required r eports. | |
1023 | The Commit tee Coordi nator is a ble to tra ck reporti ng of adve rse events , protocol deviation s, and pro tocol exce ptions – I ACUC, IRB, and SRS. | |
1024 | ||
1025 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1026 | ||
1027 | ||
1028 | ||
1029 | ||
1030 | I have the ability t o maintain records o f notifica tions for filing of required r eports in IACUC comm ittees. | |
1031 | ||
1032 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in R&D com mittees. | |
1033 | I have the ability t o coordina te notific ation rega rding adve rse events and proto col deviat ions in R& D committe es.. | |
1034 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports in R&D commit tees.. | |
1035 | I have the ability t o maintain records o f notifica tions for filing of required r eports in R&D commit tees. | |
1036 | ||
1037 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in Safety committees . | |
1038 | I have the ability t o coordina te notific ation rega rding adve rse | |
1039 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports. | |
1040 | I have the ability t o maintain records o f notifica tions for filing of required r eports. | |
1041 | ||
1042 | ||
1043 | ||
1044 | ||
1045 | ||
1046 | events and protocol deviations in Safety committee s. | |
1047 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports in Safety com mittees. | |
1048 | I have the ability t o maintain records o f notifica tions for filing of required r eports in Safety com mittees. | |
1049 | ||
1050 | 3.15/6.12 | |
1051 | Medium | |
1052 | PI or PI D esignee | |
1053 | To generat e investig ational dr ug informa tion recor d (Form 10 -9012) for the R&D, Safety and IACUC com mittees. | |
1054 | I have the ability t o complete Form 10-9 012 in the R&D commi ttees.I ha ve the abi lity to at tach Form 10-9012 to a study a pplication in the R& D committe es.I am pr ompted whe n an Inves tigational Drug form is requir ed in the R&D commit tees.I am prompted w hen an Inv estigation al Drug fo rm is prov ided with a link to a fillable version o f the form in the R& D committe es. | |
1055 | I have the ability t o complete Form 10-9 012 in the Safety co mmittees. | |
1056 | I have the ability t o attach F orm 10-901 2 to a stu dy applica tion in th e Safety c ommittees. | |
1057 | I am promp ted when a n Investig ational Dr ug form is required in the Saf ety commit tees. | |
1058 | I am promp ted when a n Investig ational Dr ug form is provided with a lin k to a fil lable vers ion of the form in t he Safety committees . | |
1059 | ||
1060 | ||
1061 | PI or PI D esignee is able to g enerate in vestigatio nal drug i nformation record (F orm 10-901 2)After th e form is generated, a signatu re is requ ired by th e R&D and IRB chairs . | |
1062 | ||
1063 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1064 | ||
1065 | ||
1066 | ||
1067 | ||
1068 | I have the ability t o complete Form 10-9 012 in the IACUC com mittees. | |
1069 | I have the ability t o attach F orm 10-901 2 to a stu dy applica tion in th e IACUC co mmittees. | |
1070 | I am promp ted when a n Investig ational Dr ug form is required in the IAC UC committ ees. | |
1071 | I am promp ted when a n Investig ational Dr ug form is provided with a lin k to a fil lable vers ion of the form in t he IACUC c ommittees. | |
1072 | ||
1073 | NOTE: If s tudy is of type "Inv estigation al Drug St udy", User is prompt ed to comp lete Form 10-9012 an d link pro vided. | |
1074 | ||
1075 | 3.16/6.13 | |
1076 | High | |
1077 | Committee Coordinato r | |
1078 | To notify investigat or when co ntinuing r enewals of subcommit tee review s are due in R&D, Sa fety, and IACUC comm ittees. | |
1079 | I have the ability t o notify t he PI or P I Designee 60 days b efore a st udy expire s that a c ontinuing review/ann ual report is due in R&D commi ttees. | |
1080 | ||
1081 | I have the ability t o notify t he PI or P I Designee 60 days b efore a st udy expire s that a c ontinuing review/ann ual report is due in Safety co mmittees. | |
1082 | ||
1083 | I have the ability t o notify t he PI or P I Designee 60 days b efore a st udy expire s that a c ontinuing review/ann ual report is due in IACUC com mittees. | |
1084 | The PI or PI Designe e is notif ied when a nnual rene wals of su bcommittee reviews a re due. | |
1085 | ||
1086 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1087 | 3.16.2/6.1 3.1 | |
1088 | High | |
1089 | PI or PI D esignee | |
1090 | To be noti fied when annual ren ewals of s ubcommitte e reviews are done – IACUC and IRB | |
1091 | I am notif ied when a n annual r eview is d ue in orde r to compl ete the an nual revie w of a stu dy and sub mit in IAC UC.I am no tified 90 days befor e a study expires to submit An nual Repor t in IACUC . | |
1092 | PI or PI D esignee is notified when annua l renewals of subcom mittee rev iews are d one – IACU C | |
1093 | 3.17/6.14 | |
1094 | Medium | |
1095 | AO and Com mittee Coo rdinators | |
1096 | To track F ederal-wid e Assuranc es, IRB, R &D, Safety , and IACU C registra tions, Mem orandums o f Understa nding (MOU s), and ot her accred itations i n R&D, Saf ety, and I ACUC commi ttees. | |
1097 | I have the ability t o track As surances i n the R&D committees .I have th e ability to track M OUs in the R&D commi ttees..I h ave the ab ility to t rack other accredita tions in t he R&D com mittees.I have the a bility to monitor as surances i n order to ensure co mpliance w ith Federa l and VA r egulations in the R& D committe es.I have the abilit y to monit or MOUs in order to ensure com pliance wi th Federal and VA re gulations in the R&D committee s.I have t he ability to monito r accredit ations in order to e nsure comp liance wit h Federal and VA reg ulations i n the R&D committees . | |
1098 | ||
1099 | I have the ability t o track As surances i n the Safe ty committ ees. | |
1100 | I have the ability t o track MO Us in the Safety com mittees. | |
1101 | I have the ability t o track ot her accred itations i n the Safe ty committ ees. | |
1102 | I have the ability t o monitor assurances in order to ensure compliance with Fede ral and VA regulatio ns. | |
1103 | I have the ability t o monitor MOUs in or der to ens ure compli ance with Federal | |
1104 | .NOTE: Ass urance and Accredita tion Check list is pr ovided on AO landing page. | |
1105 | The AO is able to tr ack Federa l Wide Ass urances, I RB and IAC UC registr ations, MO Us, and ot her accred itations. | |
1106 | ||
1107 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1108 | ||
1109 | ||
1110 | ||
1111 | ||
1112 | and VA reg ulations i n the Safe ty committ ees. | |
1113 | I have the ability t o monitor | |
1114 | accreditat ions in or der to | |
1115 | ensure com pliance wi th | |
1116 | Federal an d VA | |
1117 | Regulation s in the S afety comm ittees. | |
1118 | ||
1119 | I have the ability t o track As surances i n the IACU C committe es. | |
1120 | I have the ability t o track MO Us in the IACUC comm ittees. | |
1121 | I have the ability t o track ot her accred itations i n the IACU C committe es. | |
1122 | I have the ability t o monitor assurances in order to ensure compliance with Fede ral and VA regulatio ns in the IACUC comm ittees. | |
1123 | I have the ability t o monitor MOUs in or der to ens ure compli ance with Federal an d VA regul ations in the IACUC committees . | |
1124 | I have the ability t o monitor accreditat ions in or der to ens ure compli ance with Federal an d VA regul ations in the IACUC committees . | |
1125 | ||
1126 | 3.18/6.15 | |
1127 | High | |
1128 | LA (Local System Adm inistrator ) | |
1129 | To allow f or site sp ecific com mittee con figuration s and work flows in t he R&D, Sa fety, and IACUC comm ittees. | |
1130 | I have the ability t o configur e the work flow for e ach R&D co mmittee. | |
1131 | ||
1132 | I have the ability t o configur e the work flow for e ach Safety committee . | |
1133 | ||
1134 | I have the ability t o configur e the work flow for e ach IACUC committee. | |
1135 | The LA is able to im plement si te specifi c committe e configur ations and workflows . | |
1136 | ||
1137 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1138 | 3.18/6.15 | |
1139 | High | |
1140 | SA | |
1141 | To allow f or site sp ecific com mittee con figuration s and work flows R&D, Safety, a nd IACUC c ommittees. | |
1142 | I have the ability t o configur e the work flows with in and amo ng R&D com mittees in order to comply wit h local si tuation an d SOPs. | |
1143 | ||
1144 | I have the ability t o configur e the work flows with in and amo ng Safety committees in order to comply with local situation and SOPs. | |
1145 | ||
1146 | I have the ability t o configur e the work flows with in and amo ng IACUC c ommittees in order t o comply w ith local situation and SOPs.N OTE: Workf low config uration to ol is avai lable on t he LSA lan ding page. | |
1147 | The SA is able to im plement si te-specifi c committe e configur ations and workflows | |
1148 | ||
1149 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1150 | 3.19/6.16 | |
1151 | Medium | |
1152 | RCO | |
1153 | Provide co mpliance c hecklist f or RCO and the Safet y committe es. | |
1154 | The RCO sh ould be ab le to have a version of the OR O checklis t online.T he RCO sho uld be abl e to have an online version of the check list avail able in or der to com plete comp liance rep orts. | |
1155 | ||
1156 | The Safety committee should be able to h ave a vers ion of the ORO check list onlin e. | |
1157 | ||
1158 | The Safety committee should be able to h ave an onl ine versio n of the c hecklist a vailable i n order to complete compliance reports.N OTE: Check list is av ailable on RCO landi ng page. | |
1159 | The RCO is able to o btain the compliance checklist online. | |
1160 | 3.2/6.17 | |
1161 | High | |
1162 | PI or PI D esignee | |
1163 | Automate c reation of Research Protocol S afety Surv ey (RPSS) (VA Form 1 0-0398) | |
1164 | The PI or PI Designe e must be able to su bmit Form 10-0398 as a compone nt of a st udy applic ation.The PI or PI D esignee mu st be able to comple te the Saf ety Survey in order to determi ne which t ypes of sa fety revie ws may be required.N OTE: A lin k is avail able in th e online s tudy appli cation to access and complete Form 10-03 98 (for IR B only) | |
1165 | The PI or PI Designe e is able to access, fill out and submit an automa ted Resear ch Protoco l Safety S urvey (RPS S) (VA For m 10-0398) online. | |
1166 | 3.21/6.18 | |
1167 | High | |
1168 | Associate Chief of S taff (ACOS ) | |
1169 | To be prov ided with a landing page for A COS and AO in the R&D , Safety, and IACUC committees . | |
1170 | The ACOS w ill be pro vided with a landing page in t he R&D com mittees. | |
1171 | The ACOS w ill be pro vided with a landing page in t he Safety committees . | |
1172 | The ACOS w ill be pro vided with a landing page in t he IACUC c ommittees. | |
1173 | The ACOS w ill be pro vided with a landing page. | |
1174 | ||
1175 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1176 | 3.21/6.18 | |
1177 | High | |
1178 | AO | |
1179 | To be prov ided with a landing page for A COS and AO in the R& D, Safety, and the I ACUC commi ttees. | |
1180 | ||
1181 | AO – Admin istrative Officer | |
1182 | ACOS - Ass istant Chi ef of Staf f | |
1183 | The AO wil l be provi ded with a landing p age in the R&D commi ttees. | |
1184 | The AO wil l be provi ded with a landing p age in the Safety co mmittees. | |
1185 | The AO wil l be provi ded with a landing p age in the IACUC com mittees. | |
1186 | The AO wil l be provi ded with a landing p age. | |
1187 | ||
1188 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1189 | ||
1190 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 4/Elaborat ion Busine ss Require ment 7. | |
1191 | Table 6: E pic BN4 | |
1192 | Epic BN4: Manage dat a about pe rsonnel en gaged in r esearch at VAMC faci lities. | |
1193 | ID | |
1194 | Priority | |
1195 | As a… | |
1196 | I want… | |
1197 | So that… | |
1198 | Acceptance Criteria/ User Story Notes | |
1199 | 4.2 | |
1200 | High – aut omate conn ections be tween Coll aborative Institutio nal Traini ng (CITI), Talent Ma nagement S ystem (TMS ) and RAMS | |
1201 | Principal Investigat or or PI D esignee an d Committe e Coordina tors | |
1202 | To automat e the trac king of tr aining, sc ope of pra ctice, and all neces sary certi fications for PIs an d other em ployees in the R&D, Safety, an d IACUC co mmittees. | |
1203 | I have the ability t o track th e training status of personnel attached to a study in the R& D committe e.I have t he ability to certif y that per sonnel att ached to a study hav e the prer equisite a nd requisi te trainin g in order to meet F ederal and VA guidel ines, rule s, and reg ulations i n the R&D committee .I have th e ability to certify that pers onnel atta ched to a study have the certi fications in order t o meet Fed eral and V A guidelin es, rules, and regul ations in the R&D co mmittee. | |
1204 | ||
1205 | I have the ability t o track th e training status of personnel attached to a study in the Sa fety commi ttee. | |
1206 | I have the ability t o certify that perso nnel attac hed to a s tudy have the prereq uisite and requisite training in order t o meet Fed eral and V A guidelin es, rules, and regul ations in the Safety committee . | |
1207 | I have the ability t o certify that perso nnel attac hed to a s tudy have the certif ications i n order to meet Fede ral and VA guideline s, rules, and regula tions in t he Safety committee. | |
1208 | ||
1209 | I have the ability t o track th e training status of personnel attached to a study in the IA CUC commit tee. | |
1210 | I have the ability t o certify that perso nnel attac hed to a s tudy have the prereq uisite and requisite training in order t o meet Fed eral and V A guidelin es, rules, and regul ations in the IACUC committee. | |
1211 | I have the ability t o certify that perso nnel attac hed to a s tudy have the certif ications i n order to meet Fede ral and VA guideline s, rules, and regula tions in t he IACUC c ommittee. | |
1212 | To be able to automa te the tra cking of t raining, s cope of pr actice, an d all nece ssary cert ifications for PIs a nd other e mployees.N OTE: A tra ining reco rd is avai lable for research p ersonnel a nd notific ations are sent to t he PI or P I Designee and User when train ing is abo ut to expi re. | |
1213 | ||
1214 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1215 | 4.3 | |
1216 | Medium | |
1217 | Principal Investigat or or PI D esigneeand RAMS User | |
1218 | To notify PI or PI D esignee an d employee when trai ning is re quired inc luding ann ual/biannu al re-trai ning in th e R&D, Saf ety, and I ACUC commi ttees. | |
1219 | I have the ability t o have a l ink to ref erence wha t training is requir ed for eve ry assigne d research task in t he R&D com mittee.I h ave the ab ility to b e notified if a team member’s training i s about to expire in order to maintain a qualified staff in the R&D co mmittee.I have the a bility to have a lin k to know what train ing is req uired for my assigne d research tasks in the R&D co mmittee. | |
1220 | ||
1221 | I have the ability t o have a l ink to ref erence wha t training is requir ed for eve ry assigne d research task in t he Safety committee. | |
1222 | I have the ability t o be notif ied if a t eam member ’s trainin g is about to expire in order to maintai n a qualif ied staff in the Saf ety commit tee. | |
1223 | I have the ability t o have a l ink to kno w what tra ining is r equired fo r my assig ned resear ch tasks i n the Safe ty committ ee. | |
1224 | ||
1225 | To be able to notify PI or PI Designee a nd employe e when tra ining is r equired in cluding an nual/biann ual re-tra ining. | |
1226 | ||
1227 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1228 | ||
1229 | ||
1230 | ||
1231 | ||
1232 | I have the ability t o have a | |
1233 | link to re ference wh at | |
1234 | training i s required for every assigned research | |
1235 | task in th e IACUC co mmittee. | |
1236 | I have the ability t o be | |
1237 | notified i f a team m ember’s tr aining is | |
1238 | about to e xpire in o rder to ma intain a q ualified s taff in th e IACUC co mmittee. | |
1239 | I have the ability t o have a | |
1240 | link to kn ow what tr aining is required f or my assi gned resea rch tasks in the IAC UC committ ee. | |
1241 | ||
1242 | 4.4 | |
1243 | Medium | |
1244 | Administra tive Offic er | |
1245 | To notify Without Co mpensation (WOC)/In- Person Aut henticatio n (IPA)/VA employee and sponso r when app ointment r enewal is required i n the R&D, Safety, a nd IACUC c ommittees. | |
1246 | I have the ability t o be infor med when W OC employe e appointm ents are a bout to ex pire in th e R&D comm ittee.I ha ve the abi lity to mo nitor WOC appointmen ts to ensu re all res earch staf f is quali fied in th e R&D comm ittee. | |
1247 | ||
1248 | I have the ability t o be infor med when W OC employe e appointm ents are a bout to ex pire in th e Safety c ommittee. | |
1249 | I have the ability t o monitor WOC appoin tments to ensure all research staff is q ualified i n the Safe ty committ ee. | |
1250 | ||
1251 | I have the ability t o be infor med when W OC employe e appointm ents are a bout to ex pire in t he IACUC c ommittee. | |
1252 | I have the ability t o monitor WOC appoin tments to ensure all research staff is q ualified i n the IACU C committe e. | |
1253 | To be able to notify WOC/IPA/V A employee and spons or when ap pointment renewal is required. NOTE: Repo rt of WOC staff and appointmen t status i s availabl e from AO landing pa ge. | |
1254 | ||
1255 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1256 | 4.5 | |
1257 | Low | |
1258 | Administra tive Offic er | |
1259 | To track k ey, person al compute r (PC), an d badge as signments/ issues in the R&D, S afety, and the IACUC committee s. | |
1260 | I have the ability t o access d ata that l inks perso nnel to ba dges in th e R&D comm ittee.I ha ve the abi lity to ac cess data that links personnel to keys i n the R&D committee. I have the ability t o access d ata that l inks perso nnel to eq uipment in the R&D c ommittee. I have the ability t o ensure t hat badges are assig ned to the appropria te personn el in orde r to maint ain physic al securit y in the R &D committ ee.I have the abilit y to ensur e that key s are assi gned to th e appropri ate person nel in ord er to main tain physi cal securi ty in the R&D commit tee. | |
1261 | ||
1262 | I have the ability t o access d ata that l inks perso nnel to ba dges in th e Safety c ommittee. | |
1263 | I have the ability t o access d ata that l inks perso nnel to ke ys in the Safety com mittee. | |
1264 | ||
1265 | To be able to track key, PC, a nd badge a ssignments /issues.NO TE: Report of key, b adges, and equipment assigned to personn el is avai lable on t he AO land ing page. | |
1266 | ||
1267 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1268 | ||
1269 | ||
1270 | ||
1271 | ||
1272 | I have the ability t o access d ata that l inks perso nnel to eq uipment in the Safet y committe e. | |
1273 | I have the ability t o ensure t hat badges are assig ned to the | |
1274 | appropriat e personne l in order to mainta in physica l | |
1275 | security i n the Safe ty committ ee. | |
1276 | I have the ability t o ensure t hat keys a re | |
1277 | assigned t o the appr opriate pe rsonnel in | |
1278 | order to m aintain ph ysical sec urity in t he Safety committee. | |
1279 | ||
1280 | I have the ability t o access d ata that l inks perso nnel to ba dges in th e IACUC co mmittee. | |
1281 | I have the ability t o access d ata that l inks perso nnel to ke ys in the IACUC comm ittee. | |
1282 | I have the ability t o access d ata that l inks perso nnel to eq uipment in the IACUC committee . | |
1283 | I have the ability t o ensure t hat badges are assig ned to the appropria te personn el in orde r to maint ain physic al securit y in the I ACUC commi ttee. | |
1284 | I have the ability t o ensure t hat keys a re assigne d to the a ppropriate personnel in order to maintai n physical security in the IAC UC committ ee. | |
1285 | ||
1286 | 4.6 | |
1287 | Low | |
1288 | Administra tive Offic er | |
1289 | To track a nd certify effort on projects in the R&D , Safety, and the IA CUC commit tees. | |
1290 | I have the ability t o monitor labor char ged to res earch proj ects at a station fo r the R&D committee. I have the ability t o monitor effort on projects t o avoid co st overrun s for the R&D commit tee. | |
1291 | ||
1292 | I have the ability t o monitor labor char ged to res earch proj ects at a station fo r the Safe ty committ ee. | |
1293 | I have the ability t o monitor effort on projects t o avoid co st overrun s for the Safety com mittee. | |
1294 | ||
1295 | I have the ability t o monitor labor char ged to res earch proj ects at a station fo r the IACU C committe e. | |
1296 | I have the ability t o monitor effort on projects t o avoid co st overrun s for the IACUC comm ittee. | |
1297 | To be able to track and certif y effort o n projects . | |
1298 | ||
1299 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1300 | 4.7 | |
1301 | Medium | |
1302 | Committee Coordinato r | |
1303 | To track C OI Disclos ures in th e R&D, Saf ety, and I ACUC commi ttees. | |
1304 | I have the ability t o track CO I disclosu res for su bmitted st udy applic ation and renewals i n the R&D committees . | |
1305 | I have the ability t o track CO I disclosu res for su bmitted st udy applic ation and renewals i n the Safe ty committ ees. | |
1306 | I have the ability t o track CO I disclosu res for su bmitted st udy applic ation and renewals i n the IACU C committe es. | |
1307 | To be able to track COI Disclo sures. | |
1308 | ||
1309 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1310 | 4.8 | |
1311 | High | |
1312 | Principal Investigat or or PI D esignee | |
1313 | To add per sonnel to study team ; set role s and noti ficationsi n the R&D, Safety, a nd IACUC c ommittees. | |
1314 | I have the ability t o add pers onnel to t he study t eam in the R&D commi ttees.I ha ve the abi lity to se t roles fo r each stu dy in the R&D commit tees. | |
1315 | ||
1316 | I have the ability t o add pers onnel to t he study t eam in the Safety co mmittees. | |
1317 | I have the ability t o set role s for each study in the Safety committee s.. | |
1318 | I have the ability t o add pers onnel to t he study t eam in the IACUC com mittees. | |
1319 | I have the ability t o set role s for each study in the IACUC committees . | |
1320 | To be able to add pe rsonnel to study tea m; set rol es and not ifications . | |
1321 | ||
1322 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1323 | 4.9 | |
1324 | High | |
1325 | Committee Coordinato r | |
1326 | To receive a notific ation when changes o r addition s are made to the st udy team i n the R&D, Safety, a nd IACUC c ommittees. | |
1327 | I can be a ware of ad ditions of changes m ade by the PI or PI Designee i n the R&D committees . | |
1328 | I can be a ware of ad ditions of changes m ade by the PI or PI Designee i n the Safe ty committ ees. | |
1329 | I can be a ware of ad ditions of changes m ade by the PI or PI Designee i n the IACU C committe es. | |
1330 | To receive notificat ions when personnel are added/ removed fr om the stu dy team. | |
1331 | ||
1332 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1333 | ||
1334 | ||
1335 | ||
1336 | ||
1337 | ||
1338 | ||
1339 | ||
1340 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 5/Elaborat ion Busine ss Require ment 8. | |
1341 | Table 7: E pic BN5 | |
1342 | Epic BN5: Manage dat a about la boratory s pace and s afety. | |
1343 | ID | |
1344 | Priority | |
1345 | As a… | |
1346 | I want… | |
1347 | So that… | |
1348 | Acceptance Criteria/ User Story Notes | |
1349 | 5.1 | |
1350 | Medium | |
1351 | Administra tive Offic er | |
1352 | To track l aboratory space allo cations R& D, Safety, and IACUC committee s. | |
1353 | I have the ability t o have dat a about ho w lab spac e is alloc ated and w ho is resp onsible fo r each lab in the R& D committe e.I have t he ability to track usage of l ab space t o ensure t hat facili ties for V A research are avail able in th e R&D comm ittee. | |
1354 | I have the ability t o have dat a about ho w lab spac e is alloc ated and w ho is resp onsible fo r each lab in the Sa fety commi ttee.. | |
1355 | I have the ability t o track us age of lab space to ensure tha t faciliti es for VA research a re availab le in the Safety com mittee. | |
1356 | I have the ability t o have dat a about ho w lab spac e is alloc ated and w ho is resp onsible fo r each lab in the IA CUC commit tee. | |
1357 | I have the ability t o track us age of lab space to ensure tha t faciliti es for VA research a re availab le in the IACUC comm ittee. | |
1358 | To be able to track laboratory space all ocations.N OTE: Lab S pace Repor t is acces sible from the AO la nding page . | |
1359 | ||
1360 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1361 | 5.2 | |
1362 | Medium | |
1363 | Principal Investigat or or PI D esignee | |
1364 | To add dat a to labor atory insp ection for m in the S afety comm ittees. | |
1365 | I have the ability t o track la b inspecti ons in the Safety co mmittees.I have the ability to record la b inspecti ons in the Safety co mmittees.I have the ability to ensure th at lab ins pections a re up to d ate in ord er to avoi d shutdown s in the S afety comm ittees. | |
1366 | To be able to add da ta to labo ratory ins pection fo rm.NOTE: A tlanta VAM C LASIF fo rm availab le online as a compo nent of RA MS. | |
1367 | 5.3 | |
1368 | Medium | |
1369 | Administra tive Offic erand Prin cipal Inve stigator o r PI Desig nee | |
1370 | To generat e and trac k annual l ab safety self-evalu ation form s and lab safety in the Safety committee s. | |
1371 | I have the ability t o track va rious lab safety rep orts in th e Safety c ommittees. I have the ability t o ensure t hat lab in spections are up to date in or der to avo id shutdow ns in the Safety com mittees. | |
1372 | To be able to genera te and tra ck annual lab safety self-eval uation for ms and lab safety.NO TE: LASIF form avail able onlin e as a com ponent of RAMS. | |
1373 | 5.4 | |
1374 | Medium | |
1375 | Principal Investigat or or PI D esignee | |
1376 | To maintai n inventor y of chemi cals, sele ct agents, and bioha zards of t he Safety commitee. | |
1377 | I have the ability t o monitory inventory of chemic als in the Safety co mmittees.I have the ability to monitor i nventory o f biohazar ds in the Safety com mittees.I have the a bility to access dat a detailin g stored c hemicals i n order to comply wi th Federal regulatio ns in the Safety com mittees.I have the a bility to access dat a detailin g stored m iscellaneo us agents in order t o comply w ith Federa l regulati ons in the Safety co mmittees.I have the ability to specify i f material s are lab specific i n the Safe ty committ ees. | |
1378 | To be able to mainta in invento ry of chem icals, sel ect agents , and bioh azards. | |
1379 | 5.5 | |
1380 | Medium | |
1381 | Administra tive Offic er | |
1382 | To manage tissue ban k location data in t he R&D, Sa fety and I ACUC commi ttees. | |
1383 | I have the ability t o monitor informatio n about a tissue ban k in the R &D committ ees. | |
1384 | ||
1385 | I have the ability t o monitor informatio n about a tissue ban k in the S afety comm ittees. | |
1386 | ||
1387 | I have the ability t o monitor informatio n about a tissue ban k in the I ACUC commi ttees. | |
1388 | ||
1389 | To be able to manage tissue-ba nking data . | |
1390 | ||
1391 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1392 | 5.6 | |
1393 | Medium | |
1394 | Administra tive Offic er | |
1395 | To manage data shari ng agreeme nts, data repository approvals , and annu al reports in the R& D, Safety, and IACUC committee s. | |
1396 | I have the ability t o manage e lectronic versions o f data sha ring agree ments in t he R&D com mittees.I have the a bility to manage ele ctronic ve rsions of data repos itory agre ements in the R&D co mmittees.I have the ability to have lega l prepared reviews t hat requir e MOU agre ements in the R&D co mmittees.I have the ability to have regu latory rev iews that require MO U agreemen ts in the R&D commit tees.I hav e the abil ity to hav e regulato ry reviews that requ ire data s haring agr eements in the R&D c ommittees. | |
1397 | ||
1398 | I have the ability t o manage e lectronic versions o f data sha ring agree ments in t he Safety committees . | |
1399 | I have the ability t o manage e lectronic versions o f data rep ository ag reements i n the Safe ty committ ees. | |
1400 | ||
1401 | To be able to manage data shar ing agreem ents, data repositor y approval s, and ann ual report s.NOTE: Da ta sharing agreement s are stor ed as tagg ed documen ts. | |
1402 | ||
1403 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1404 | ||
1405 | ||
1406 | ||
1407 | ||
1408 | I have the ability t o have leg al prepare d reviews that requi re MOU agr eements in the Safet y committe es. | |
1409 | I have the ability t o have | |
1410 | regulatory reviews t hat requir e MOU agre ements in the Safety committee s. | |
1411 | I have the ability t o have reg ulatory re views that require d ata sharin g | |
1412 | Agreements in the Sa fety commi ttees. | |
1413 | ||
1414 | I have the ability t o manage e lectronic versions o f data sha ring agree ments in t he Safety committees . | |
1415 | I have the ability t o manage e lectronic versions o f data rep ository ag reements i n the Safe ty committ ees. | |
1416 | I have the ability t o have leg al prepare d reviews that requi re MOU agr eements in the Safet y committe es. | |
1417 | ||
1418 | ||
1419 | ||
1420 | ||
1421 | ||
1422 | ||
1423 | ||
1424 | I have the ability t o have reg ulatory re views that require M OU agreeme nts in the Safety co mmittees. | |
1425 | I have th e ability to have re gulatory r eviews tha t require data shari ng agreeme nts in the Safety co mmittees. | |
1426 | ||
1427 | 5.7 | |
1428 | Medium | |
1429 | Animal Fac ility Mana ger (AFM) | |
1430 | To manage animal cen sus in the IACUC and Safety co mmittee. | |
1431 | I have the ability t o maintain a census of animals stored in our Veter inary Medi cal Unit ( VMU) in th e IACUC co mmittees.I have the ability to maintain an up-to-d ate animal census to ensure th at animals are avail able for s tudies in the Safety committee s. | |
1432 | I have the ability t o ensure t he AFM is a role in RAMS and i n the Safe ty committ ees.. | |
1433 | To be able to manage animal ce nsus. | |
1434 | ||
1435 | ||
1436 | ||
1437 | ||
1438 | ||
1439 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 6/Elaborat ion Busine ss Require ment 9. | |
1440 | Table 8: E pic BN6 | |
1441 | Epic BN6: Central Of fice repor ting requi rements. | |
1442 | ID | |
1443 | Priority | |
1444 | As a… | |
1445 | I want… | |
1446 | So that… | |
1447 | Acceptance Criteria/ User Story Notes | |
1448 | 6.1 | |
1449 | Medium | |
1450 | Administra tive Offic er | |
1451 | To create real-time expenditur e reports R&D, Safet y, and IAC UC committ ees. | |
1452 | I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the R&D commi ttees.I ha ve the abi lity to al locate exp enditures to researc h projects in order to ensure each is wi thin budge t in the R &D committ ees.. | |
1453 | ||
1454 | I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the Safety co mmittees. | |
1455 | I have the ability t o allocate expenditu res to res earch proj ects in or der to ens ure each i s within b udget in t he Safety committees . | |
1456 | ||
1457 | I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the IACUC com mittees. | |
1458 | I have the ability t o allocate expenditu res to res earch proj ects in or der to ens ure each i s within b udget in t he IACUC c ommittees. | |
1459 | To be able to create real-time expenditu re reports . | |
1460 | ||
1461 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1462 | 6.2 | |
1463 | High | |
1464 | Administra tive Offic er | |
1465 | To provide query and reporting tools for administr ative rese arch data in the R&D , Safety a nd IACUC. | |
1466 | I have the ability t o respond to data re quests fro m Central Office in the R&D co mmittees.I have the ability to respond t o status r equests fr om Central Office in the R&D c ommittees. | |
1467 | ||
1468 | I have the ability t o respond to data re quests fro m Central Office in the Safety committee s. | |
1469 | I have the ability t o respond to status requests f rom Centra l Office i n the Safe ty committ ees. | |
1470 | ||
1471 | I have the ability t o respond to data re quests fro m Central Office in the IACUC committees . | |
1472 | I have the ability t o respond to status requests f rom Centra l Office i n the IACU C committe es. | |
1473 | To be able to provid e query an d reportin g tools fo r administ rative res earch data . | |
1474 | ||
1475 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1476 | 6.12 | |
1477 | High | |
1478 | RAMS User | |
1479 | To export raw data i n XML that can be an alyzed wit h third-pa rty busine ss intelli gence anal ysis and v isualizati on tools i n the R&D, Safety, a nd IACUC c ommittees. | |
1480 | I have the ability t o export d ata for us e in Micro soft (MS) Excel and other anal ysis packa ges in the R&D commi ttees.I ha ve the abi lity to ex port data for use in other ana lysis pack ages in th e R&D comm ittees.I h ave the ab ility to e xport data to MS Pow erPoint in order to make prese ntation gr aphs in th e R&D comm ittees. | |
1481 | ||
1482 | I have the ability t o export d ata for us e in Micro soft (MS) Excel and other anal ysis packa ges in the Safety co mmittees. | |
1483 | I have the ability t o export d ata for us e in other analysis packages i n the Safe ty committ ees. | |
1484 | I have the ability t o export d ata to MS PowerPoint in order to make pr esentation graphs in the Safet y committe es. | |
1485 | ||
1486 | I have the ability t o export d ata for us e in Micro soft (MS) Excel and other anal ysis packa ges in the IACUC com mittees. | |
1487 | ||
1488 | To be able to export raw data in XML tha t can be a nalyzed wi th third-p arty busin ess intell igence ana lysis and visualizat ion tools. | |
1489 | ||
1490 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1491 | Table 9: E pic BN7 | |
1492 | Epic BN7: System wil l interfac e with VA systems | |
1493 | ID | |
1494 | Priority | |
1495 | As a… | |
1496 | I want… | |
1497 | So that… | |
1498 | Acceptance Criteria/ User Story Notes | |
1499 | ||
1500 | ||
1501 | ||
1502 | ||
1503 | I have the ability t o export d ata for us e in other analysis packages i n the IACU C committe es. | |
1504 | I have the ability t o export d ata to MS PowerPoint in order to make pr esentation graphs in the IACUC committee s. | |
1505 | ||
1506 | 7.2/10.2 | |
1507 | Medium | |
1508 | Administra tive Offic er | |
1509 | to support automated data impo rt from Co llaborativ e Institut ional Trai ning (CITI ). | |
1510 | the CITI s ystem must interface with RAMS and the C ITI traini ng data wi ll availab le to RAMS users. | |
1511 | The AO is able to ac cess data in CITI us ing RAMS. | |
1512 | 7.5/10.5 | |
1513 | Medium | |
1514 | Administra tive Offic er | |
1515 | to support automated data impo rt from Ta lent Manag ement Syst em (TMS). | |
1516 | the TMS mu st interfa ce with RA MS in orde r to acces s the RAMS training records. | |
1517 | The AO is able to ac cess data in TMS usi ng RAMS. | |
1518 | ||
1519 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 8. This Bu siness Req uirement w as not in the initia l Business Requireme nts Docume nt (BRD). Updates wi ll be made to the BR D. The tab le below w as not inc luded in t he initial Research Office, al l committe esElaborat ion Busine ss Require ments docu ment. | |
1520 | Table 10: Epic BN8 | |
1521 | Epic BN8: The system will crea te a Docum ent Manage ment Proce ss. | |
1522 | ID | |
1523 | Priority | |
1524 | As a… | |
1525 | I want… | |
1526 | So that… | |
1527 | Acceptance Criteria\ User Story Notes | |
1528 | 8.1 | |
1529 | High | |
1530 | Administra tive Offic er | |
1531 | Associate Chief of S taff for R esearch | |
1532 | Committee Coordinato r/ | |
1533 | Committee Administra tor | |
1534 | Principle Investigat or or PI D esignee | |
1535 | Co-Princip le Investi gator | |
1536 | IRB Admini strator | |
1537 | IRB Chair | |
1538 | IRB Member | |
1539 | IRB Staff | |
1540 | Local Site | |
1541 | Investigat or (CIRB R ole Only) | |
1542 | Local RAMS Administr ator | |
1543 | Study Coor dinator | |
1544 | ORD Admini strator | |
1545 | The system to allow editing, p rinting, a nd storage of IRB, I ACUC, R&D and Safety documents . | |
1546 | The system must allo w editing of IRB doc uments. | |
1547 | The system must allo w printing of IRB do cuments. | |
1548 | The system must allo w storage of IRB doc uments. | |
1549 | The system must allo w editing of IACUC d ocuments. | |
1550 | The system must allo w printing of IACUC documents. | |
1551 | The system must allo w storage of IACUC d ocuments. | |
1552 | The system must allo w editing of R&D doc uments. | |
1553 | The system must allo w printing of R&D do cuments. | |
1554 | The system must allo w storage of R&D doc uments. | |
1555 | The system must allo w editing of Safety documents. | |
1556 | The system must allo w printing of Safety documents . | |
1557 | The system must allo w storage of Safety documents. | |
1558 | The system will succ essfully e dit, print , and stor e document s for each committee . | |
1559 | ||
1560 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1561 | ||
1562 | ||
1563 | The table below list s the Epic and detai led User N arratives (Business Requiremen ts) for BN 8. This Bu siness Req uirement w as not in the initia l Business Requireme nts Docume nt (BRD). Updates wi ll be made to the BR D. The tab le below w as not inc luded in t he initial Elaborati on Busines s Requirem ents docum ent. | |
1564 | Table 11: Epic BN9 | |
1565 | Epic BN9: Develop a Reporting Management Module | |
1566 | ID | |
1567 | Priority | |
1568 | As a… | |
1569 | I want… | |
1570 | So that… | |
1571 | Acceptance Criteria/ User Story Notes | |
1572 | 9.1 | |
1573 | High | |
1574 | Committee Coordinato r/Committe e Administ rator, IRB Administr ator, IRB Staff | |
1575 | To integra te a compl ete report ing capabi lity for U ser define d and pre- defined ge nerated re ports in t he R&D, Sa fety, and IACUC comm ittees. | |
1576 | I have tra cking capa bilities f or necessa ry R&D com mittee act ivity. | |
1577 | ||
1578 | I have tra cking capa bilities f or necessa ry Safety committee activity. | |
1579 | ||
1580 | I have tra cking capa bilities f or necessa ry IACUC c ommittee a ctivity. | |
1581 | I have tra cking capa bilities f or necessa ry committ ee activit y. | |
1582 | ||
1583 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1584 | 9.2 | |
1585 | High | |
1586 | Administra tive Offic er, | |
1587 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator, IRB Administr ator, IRB Staff | |
1588 | ||
1589 | To see a s tudy listi ng by Loca l Site in the R&D, S afety, and IACUC com mittees. | |
1590 | Reports ca n be print ed out by site listi ng all of the studie s open at those site s to inclu de IRB Num ber, fundi ng agency, study tit le, the LS I/Co-LSIs, approval date, and continuing review ex piration d ate in the IRB commi ttees. | |
1591 | ||
1592 | Reports ca n be print ed out by site listi ng all of the studie s open at those site s to inclu de R&D Num ber, fundi ng agency, study tit le, the LS I/Co-LSIs, approval date, and continuing review ex piration d ate in the R&D commi ttees. | |
1593 | ||
1594 | Reports ca n be print ed out by site listi ng all of the studie s open at those site s to inclu de Safety Number, fu nding agen cy, study title, the LSI/Co-LS Is, approv al date, a nd continu ing review expiratio n date in the Safety committee s. | |
1595 | ||
1596 | Reports ca n be print ed out by site listi ng all of the studie s open at those site s to inclu de IACUC N umber, fun ding agenc y, study t itle, the LSI/Co-LSI s, approva l date, an d continui ng review expiration date in t he IACUC c ommittees. | |
1597 | Reports ca n be print ed out by site listi ng all of the studie s open at those site s to inclu de IRB Num ber, fundi ng agency, study tit le, the LS I/Co-LSIs, approval date, and continuing review ex piration d ate. | |
1598 | ||
1599 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1600 | 9.3 | |
1601 | High | |
1602 | Committee Coordinato r/ Committ ee Adminis trator, IR B Administ rator, IRB Staff | |
1603 | To retriev e an Activ e study li sting in t he R&D, Sa fety, and IACUC comm ittees. | |
1604 | A listing of all act ive studie s can be r etrieved b y IRB numb er, fundin g source, whether st udy is FDA -regulated , study ti tle, numbe r of sites , PI/Co-PI s, Primary Reviewer, Assigned VA Central IRB Mange r, Risk Le vel, Appro val Date, Continuing Review, a nd Approva l Expirati on Date. ( I am assum ing that w e will be able to so rt this pa rticular r eport to r un a repor t, for exa mple, only FDA-regul ated studi es or only studies f unded by C SP in the R&D commit tees. | |
1605 | ||
1606 | A listing of all act ive studie s can be r etrieved b y IRB numb er, fundin g source, whether st udy is FDA -regulated , study ti tle, numbe r of sites , PI/Co-PI s, Primary Reviewer, Assigned VA Central IRB Mange r, Risk Le vel, Appro val Date, Continuing Review, a nd Approva l Expirati on Date. ( I am assum ing that w e will be able to so rt this. | |
1607 | ||
1608 | ||
1609 | To retriev e an Activ e study li sting. | |
1610 | ||
1611 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1612 | ||
1613 | ||
1614 | ||
1615 | ||
1616 | particular report to run a rep ort, for e xample, on ly FDA- re gulated st udies or o nly studie s funded b y CSP in t he Safety committees . | |
1617 | ||
1618 | A listing of all act ive studie s can be r etrieved b y IRB numb er, fundin g source, whether st udy is FDA -regulated , study ti tle, numbe r of sites , PI/Co-PI s, Primary Reviewer, Assigned VA Central IRB Mange r, Risk Le vel, Appro val Date, Continuing Review, a nd Approva l Expirati on Date. ( I am assum ing that w e will be able to so rt this pa rticular r eport to r un a repor t, for exa mple, only FDA-regul ated studi es or only studies f unded by C SP in the IACUC comm ittees. | |
1619 | ||
1620 | 9.4 | |
1621 | High | |
1622 | Committee Coordinato r/ Committ ee Adminis trator, R& D Administ rator, R&D Staff, Sa fety Admin istrator, Safety Sta ff, IACUC Administra tor, IACUC Staff | |
1623 | To retriev e an Exped ited Listi ng in the R&D, Safet y, and IAC UC committ ees. | |
1624 | A report c an be run for a spec ified peri od of time to report all study action ap proved und er expedit ed procedu res for th e next Boa rd meeting in the R& D committe es. This i ncludes ap proval of new studie s, local s ites, cont inuing rev iews of bo th PI and LSI Applic ations, an d PI and L SI Amendme nts, as we ll as revi ew and act ion taken on UAP, SA E, Protoco l Deviatio n, Site Cl osure, and Study Clo sure Repor ts for the R&D commi ttee. | |
1625 | ||
1626 | A report c an be run for a spec ified peri od of time to report all study action ap proved und er expedit ed procedu res for th e next Boa rd meeting for the S afety comm ittee. Thi s includes approval of new stu dies, loca l sites, c ontinuing reviews of both PI a nd LSI App lications, and PI an d LSI Amen dments, as well as r eview and action tak en on UAP, SAE, Prot ocol Devia tion, Site Closure, and Study | |
1627 | ||
1628 | To retriev e an Exped ited Listi ng | |
1629 | ||
1630 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1631 | ||
1632 | ||
1633 | ||
1634 | ||
1635 | ||
1636 | Closure Re ports in t he Safety committees . | |
1637 | ||
1638 | A report c an be run for a spec ified peri od of time to report all study action ap proved und er expedit ed procedu res for th e next Boa rd meeting the IACUC committee . This inc ludes appr oval of ne w studies, local sit es, contin uing revie ws of both PI and LS I Applicat ions, and PI and LSI Amendment s, as well as review and actio n taken on UAP, SAE, Protocol Deviation, Site Clos ure, and S tudy Closu re Reports in the IA CUC commit tees. | |
1639 | ||
1640 | 9.5 | |
1641 | High | |
1642 | Administra tive Offic er, | |
1643 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator,R&D Administra tor, R&D S taff, Safe ty Adminis trator, Sa fety Staff , IACUC A dministrat or, IACUC Staff | |
1644 | To retriev e a Listin g of studi es due con tinuing re view run f or specifi ed periods in the R& D, Safety, and IACUC committee s. | |
1645 | A listing of studies due conti nuing revi ew can be run for sp ecified pe riods show ing R&D nu mber, stud y title, d ate due, d ate report received, date CR a pproved, a nd date CR reported to Board f or expedit ed review, if applic able. Also includes sub headin gs of site s for each study lis ting: site , LSI, dat e report r eceived, d ate approv ed, and da te expedit ed review reported t o R&D if a pplicable in the R&D committee s. | |
1646 | ||
1647 | A listing of studies due conti nuing revi ew can be run for sp ecified pe riods show ing Safety number, s tudy title , date due , date rep ort receiv ed, date C R approved , and date CR report ed to Boar d for expe dited revi ew, if app licable. A lso includ es sub hea dings of s ites for e ach study listing: s ite, LSI, date repor t received , date app roved, and date expe dited revi ew reporte d to Safet y if appli cable in t he Safety committees . | |
1648 | ||
1649 | A listing of studies due conti nuing revi ew can be run for sp ecified pe riods show ing IACUC number, st udy title, date due, date repo rt receive d, date CR approved, and date CR reporte d to Board for exped ited revie w, if appl icable. Al so include s sub head ings of si tes for ea ch study l isting: si te, LSI, d ate report received, date appr oved, and date exped ited revie w reported to IACUC if applica ble in the IACUC com mittees. | |
1650 | To retriev e a Listin g of studi es due con tinuing re view run f or specifi ed periods . | |
1651 | ||
1652 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1653 | ||
1654 | 9.6 | |
1655 | High | |
1656 | Committee Coordinato r/ Committ ee Adminis trator, R& D Administ rator, R&D Staff, Sa fety Admin istrator, Safety Sta ff, IACUC Administr ator, IACU C Staff | |
1657 | To retriev e a Listin g of close d projects and sites in the R& D, Safety, and IACUC committee s. | |
1658 | I can diff erentiate between si te study c losure and main stud y closure in the R&D applicati on. | |
1659 | ||
1660 | I can diff erentiate between si te study c losure and main stud y closure in the Saf ety applic ation. | |
1661 | ||
1662 | I can diff erentiate between si te study c losure and main stud y closure in the IAC UC applica tion. | |
1663 | I can diff erentiate between si te study c losure and main stud y closure. | |
1664 | ||
1665 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1666 | 9.7 | |
1667 | High | |
1668 | Committee Coordinato r/ Committ ee Adminis trator, R& D Administ rator, R&D Staff, Sa fety Admin istrator, Safety Sta ff, IACUC Administr ator, IACU C Staff | |
1669 | ||
1670 | To retriev e study Ac tion Repor ts in the R&D, Safet y and IACU C committe e applicat ion. | |
1671 | A listing of all pen ding open actions th at can als o be broke n down and run by sp ecific act ion such a s pre-revi ews, new s tudies, PI and LSI a mendments, Local Sit e Applicat ions, Upda tes, SAE/U APs, Proto col Deviat ions, Upda tes in Pro gress, and Review of Audit and Closure R eports R&D committee applicati on. | |
1672 | ||
1673 | A listing of all pen ding open actions th at can als o be broke n down and run by sp ecific act ion such a s pre-revi ews, new s tudies, PI and LSI a mendments, Local Sit e Applicat ions, Upda tes, SAE/U APs, Proto col Deviat ions, Upda tes in Pro gress, and Review of Audit and Closure R eports Saf ety commit tee applic ation. | |
1674 | ||
1675 | A listing of all pen ding open actions th at can als o be broke n down and run by sp ecific act ion such a s pre-revi ews, new s tudies, PI and LSI a mendments, Local Sit e Applicat ions, Upda tes, SAE/U APs, Proto col Deviat ions, Upda tes in Pro gress, and Review of Audit and Closure R eports IAC UC committ ee applica tion. | |
1676 | To retriev e study Ac tion Repor ts. | |
1677 | ||
1678 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1679 | 9.8 | |
1680 | High | |
1681 | Administra tive Offic er, | |
1682 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator | |
1683 | ||
1684 | Review the Action Re ports in t he R&D, Sa fety, and IACUC comm ittee appl ication. | |
1685 | ||
1686 | A listing of all ope n actions by assigne d VA Centr al IRB Man ager or Re viewer wil l include study stat us notes R &D committ ee applica tion. | |
1687 | A listing of all ope n actions by assigne d VA Centr al IRB Man ager or Re viewer wil l include study stat us notes S afety comm ittee appl ication. | |
1688 | A listing of all ope n actions by assigne d VA Centr al IRB Man ager or Re viewer wil l include study stat us notes I ACUC commi ttee appli cation. | |
1689 | A listing of all ope n actions by assigne d VA Centr al IRB Man ager or Re viewer wil l include study stat us notes. | |
1690 | ||
1691 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1692 | ||
1693 | 9.9 | |
1694 | High | |
1695 | Administra tive Offic er, | |
1696 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator | |
1697 | To receive an annual report fr om each co mmittee me mber to th e RDC (tha t includes – | |
1698 | Committee Review Sta tistics | |
1699 | Committee Review Sta tistics- C ommittee M embers | |
1700 | Committee Review Sta tistics – Events | |
1701 | Committee Review Sta tistics – Initial Ap provals | |
1702 | Committee Review Sta tistics – Reviewers for the R& D, safety, and IACUC committee s. | |
1703 | I can revi ew ongoing activitie s of the R &D committ ee. | |
1704 | ||
1705 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
1706 | ||
1707 | I can revi ew ongoing activitie s of the I ACUC commi ttee. | |
1708 | ||
1709 | I can revi ew ongoing activitie s of the c ommittee. | |
1710 | ||
1711 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1712 | 9.10 | |
1713 | High | |
1714 | Administra tive Offic er, | |
1715 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator, R&D Administr ator, R&D Staff, Saf ety Admini strator, S afety Staf f, IACUC Administra tor, IACUC Staff | |
1716 | ||
1717 | Receive an annual re port | |
1718 | For Direct or’s Certi fication i ncluding t he followi ng details : | |
1719 | Protocols searches | |
1720 | Summary – Protocol C ounts by T ype/Status | |
1721 | Summary – Active Pro tocols | |
1722 | Protocol D etails by PI | |
1723 | By Type (A nimal, Ani mal/Human, Human, Sc ience-Safe ty, Scienc e- only, A CORP) | |
1724 | By Status (Active, P ending, Cl osed, Expi red, etc.) | |
1725 | By Event T ype, Item Type | |
1726 | in the R&D , Safety, and IACUC committees . | |
1727 | I can revi ew ongoing activitie s of the R &D committ ee. | |
1728 | ||
1729 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
1730 | ||
1731 | I can revi ew ongoing activitie s of the I ACUC commi ttee. | |
1732 | I can revi ew ongoing activitie s of the c ommittee. | |
1733 | ||
1734 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1735 | 9.11 | |
1736 | High | |
1737 | Administra tive Offic er, | |
1738 | Associate Chief of S taff for R esearch | |
1739 | To receive a report from each of the com mittees wi th the fol lowing inf ormation: (Committee Rosters, training a nd appoint ment expir ation date s | |
1740 | Initial ap proval dat es | |
1741 | Continuing Reviews | |
1742 | o Approval s – Expira tion Unkno wn [No CR Mths] | |
1743 | o Approval s – Expire d | |
1744 | o Approval s – Unexpi red [No CR Event] | |
1745 | in the R&D , Safety, and IACUC committees . | |
1746 | I can revi ew ongoing activitie s of the R &D committ ee. | |
1747 | ||
1748 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
1749 | ||
1750 | I can revi ew ongoing activitie s of the I ACUC commi ttee. | |
1751 | I can revi ew ongoing activitie s of the c ommittee. | |
1752 | ||
1753 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1754 | 9.12 | |
1755 | High | |
1756 | Administra tive Offic er, | |
1757 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator, R&D Administr ator, Safe ty Adminis trator, I ACUC Admin istrator | |
1758 | To researc h financia l conflict of intere st in the R&D, Safet y, and IAC UC committ ees. | |
1759 | Financial conflict o f interest can be ma naged in t he R&D com mittees. | |
1760 | Financial conflict o f interest can be ma naged in t he Safety committees . | |
1761 | Financial conflict o f interest can be ma naged in t he IACUC c ommittees. | |
1762 | Financial conflict o f interest can be ma naged. | |
1763 | ||
1764 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
1765 | ||
1766 | Graphical User Inter face (GUI) Specifica tions | |
1767 | No new GUI Specifica tions have been defi ned at thi s time. Th e RAMS Int egration d evelopment team will add addit ional grap hics, coor dinated wi th the sus tainment t eam, as ne cessary. | |
1768 | Multi-Divi sional Spe cification s | |
1769 | From the p erspective of the en d User, th ere are no functiona l differen ces betwee n User loc ation and the functi onalities provided b y the RAMS Integrati on. | |
1770 | Performanc e Specific ations | |
1771 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1772 | The soluti on perform ance speci fications solution w ill execut e performa nce, capac ity, and i ndependent testing o f its prod uct, and a s part of Software Q uality Ass urance (SQ A) analysi s and test ing. | |
1773 | The ORD ai ms to impr ove the ef ficiency a nd perform ance of th e national VA resear ch program by implem enting an enterprise -wide rese arch admin istrative management system ac cessible t o: | |
1774 | ORD Centr al Office. | |
1775 | Active fie ld researc h offices | |
1776 | The implem ented tool will supp ort the ma jor busine ss functio ns of the: | |
1777 | Local Rese arch Offic e | |
1778 | Management of the Re search and Developme nt (R& D) Committee and its su bcommittee s (Institu tional Rev iew Board (IRB) | |
1779 | Institutio nal Animal Care and Use Commit tee (IACUC ) | |
1780 | Subcommitt ee on Rese arch Safet y (SRS) | |
1781 | Local rese arch offic e reportin g to ORD | |
1782 | This new f unctionali ty will pr ovide a co mmon datab ase for tr acking and reporting of admini strative r esearch pr ogram data throughou t the VA. | |
1783 | The follow ing table provides t he capacit y and perf ormance in formation for the RA MS Integra tion. | |
1784 | Table 12: Capacity a nd Perform ance | |
1785 | SLR Questi on | |
1786 | SLR Criter ia | |
1787 | How many U sers will be on the system hou rly? | |
1788 | 101-1000 e stimated | |
1789 | How many t ransaction s will eac h average User perfo rm each ho ur? | |
1790 | >10 estima ted | |
1791 | What are t he anticip ated peak User times during th e day? | |
1792 | Business d ay (highes t peak Use r times Mo n. through Fri. duri ng adminis trative ho urs) | |
1793 | What is th e anticipa ted peak t ransaction load (whe n do you t hink that there will be the mo st transac tions bein g performe d on the s ystem) dur ing the da y? | |
1794 | Business d ay (highes t peak Use r times Mo n. through Fri. duri ng adminis trative ho urs) | |
1795 | How many n ew Users w ill be add ed in one year? | |
1796 | 101-1000 e stimated | |
1797 | How many m ore (if an y) transac tions will be added in one yea r? | |
1798 | >10 estima ted | |
1799 | What kind of informa tion will be stored? (Specify average of each kind per month ) | |
1800 | Small docu ments (exa mple pdf o r Word fil e) | |
1801 | ||
1802 | Forms & Do cuments th at are for matted (ex ample form s or docum ents with images | |
1803 | What kind of search capacity i s required ? | |
1804 | Medium (11 -1000 per hour) | |
1805 | estimated | |
1806 | What type of system( s) is/are required? | |
1807 | Web based and manage d from cen tral servi ce and dat abase | |
1808 | ||
1809 | Intranet ( All VA) | |
1810 | Is there a need for heavy appl ication re porting? I f yes, whe n? | |
1811 | End of day , End of m onth, End of quarter | |
1812 | ||
1813 | Existing P erformance Specifica tion Requi rements | |
1814 | RAMS servi ce consume rs shall c onsume ser vices offe red by a s ervice pro vider in a ccordance with the s ervice con tract. | |
1815 | The RAMS S ervice Lev el Agreeme nt (SLA) c omponent o f the serv ice contra ct shall b e negotiat ed with th e service provider. | |
1816 | The RAMS S LA shall n ot be uniq ue to the service co nsumer, an d it is pr eferable t hat it not be unique . | |
1817 | RAMS shall support U sers at pe ak usage l evels, whe re peak us age is def ined in th e Users’ S ervice Lev el Agreeme nt. | |
1818 | RAMS hardw are and so ftware res ources sha ll be suff iciently s calable to support i ncreased w orkloads b y adding e quivalent resources. | |
1819 | RAMS shall process a nd use Coo rdinated U niversal T ime (UTC) for intern al and ext ernal time synchroni zation. | |
1820 | RAMS shall support 1 000 concur rent Users at peak u sage level s, where p eak usage is defined in the Us ers’ Servi ce Level A greement. | |
1821 | The data i n the RAMS datamart shall be r efreshed f rom the op erational database o nce a day. | |
1822 | RAMS Users shall hav e consiste nt respons e times wh en accessi ng RAMS ca pabilities during no rmal opera tion. | |
1823 | RAMS Users may exper ience degr aded perfo rmance whe n accessin g RAMS cap abilities from the d isaster re covery sit e when in failure or recovery mode. | |
1824 | Recurring discussion s with the Systems E ngineering and Desig n Review ( SEDR) work group will articulat e requirem ents for p erformance and capac ity transa ctions. | |
1825 | Quality At tributes S pecificati on | |
1826 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1827 | Processes for artifa ct deliver y will fol low ProPat h guidelin es, includ ing qualit y gate rev iews for r equirement s, design, code, tes t plans/ca ses/execut ions, and other docu ment deliv erables. | |
1828 | The RAMS I ntegration services will compl y with the quality s pecificati ons set fo rth by the VA PMAS Q uality spe cification s. | |
1829 | The follo wing types of testin g will be performed to assess the qualit y of the s olution: | |
1830 | Unit testi ng | |
1831 | Integratio n / functi onal testi ng | |
1832 | User Accep tance Test ing (UAT) | |
1833 | Section 50 8 testing | |
1834 | Performanc e testing | |
1835 | The RAMS I ntegration services will also consist of the follo wing quali ty specifi cations: | |
1836 | The system comprises tools, ap plications , and soft ware that conform to the VA’s standard s erver and database o perating s ystems. Th e VA Techn ical Refer ence Model (TRM) pro vides more informati on. | |
1837 | The system is design ed to oper ate in VA’ s standard , virtuali zed, opera ting syste m environm ent accord ing to the VA TRM. | |
1838 | Additional ly, as pre viously de fined, the following quality s pecificati ons will b e adhered to: | |
1839 | The RAMS I ntegration services shall appl y open dat a standard s where po ssible, su ch as W3C/ IETF, REST , SOAP, an d OASIS. | |
1840 | Services s hall apply open sche mas and no t create c ustom sche ma definit ions where possible. This is t o include service in terface st andards as well. | |
1841 | Reliabilit y Specific ations | |
1842 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1843 | The first step in th e reliabil ity engine ering proc ess is to specify th e required reliabili ty that th e equipmen t/system m ust be des igned to a chieve. Th e essentia l elements of a reli ability sp ecificatio n are: | |
1844 | A quantita tive state ment of th e reliabil ity requir ement; | |
1845 | A full des cription o f the envi ronment in which the equipment /system wi ll be stor ed, transp orted, ope rated and maintained ; | |
1846 | The time m easure or mission pr ofile; | |
1847 | A clear de finition o f what con stitutes f ailure; an d | |
1848 | A descript ion of the test proc edure, wit h accept/r eject crit eria that will be us ed to demo nstrate th e specifie d reliabil ity | |
1849 | The RAMS s olution mu st be avai lable 24 h ours per d ay and 7 d ays a week The entir e applicat ion is mon itored at multiple t iers, from applicati on perform ance/tunin g, hardwar e and infr astructure (CPU, mem ory, I/O), to networ k performa nce monito ring and c ontrol. Re liability Specificat ion requir ements ens ure the up times of t he systems are met, ensure mon itoring se rvices, an d proactiv ely respon d to proje cted syste m demands. | |
1850 | Monitoring also prov ides capac ity trendi ng, allowi ng proacti ve system modificati ons or pla nning for upgrades. | |
1851 | The system must be r eliable an d enable U ser trust. The follo wing summa rizes requ irements f or the new functiona lity from RAMS Integ ration rel iability s pecificati ons by pro viding the following : | |
1852 | Stable and reliable performanc e | |
1853 | Availabili ty – The s ystem shal l be avail able 24 ho urs per da y and 7 da ys a week | |
1854 | Accurate d ata – The system sha ll return entries ex actly as t hey were p assed with no modifi cation. | |
1855 | Defect rep air – It i s expected that all defects re lated to t he impleme ntation ge t resolved during in itial deve lopment an d subseque nt UAT tes ting. | |
1856 | Display of all data that is av ailable in native or interface d systems and intend ed to be a vailable i n the appl ication | |
1857 | Accessible informati on related to the so urce of da ta | |
1858 | When the s ystem goes live in P roduction, the devel opment tea m will add ress defec ts of a cr itical nat ure that a re deemed “show stop pers.” Enh ancement r equests ma de after ‘ go-live’ w ill be log ged for co nsideratio n in a fut ure, coord inated rel ease. | |
1859 | The follow ing table lists the availabili ty of the RAMS Integ ration sys tem. | |
1860 | Table 13: Availabili ty | |
1861 | SLR Questi on | |
1862 | SLR Criter ia | |
1863 | Descriptio n | |
1864 | How much t ime should the syste m be avail able (and how much d own time i s acceptab le due to incident [ unexpected ] outage)? | |
1865 | 99.9% (8.7 6 hours do wn time) | |
1866 | Intentiona lly left b lank. | |
1867 | When shoul d the syst em be avai lable (wha t will be the core o perating h ours of th e system)? | |
1868 | 8 a.m. to 8 p.m., ES T, Mon. th rough Fri. | |
1869 | The system shall req uire no mo re than 24 hours of maintenanc e per mont h. Servici ng and mai ntenance i s expected to occur during nig hts and we ekends. | |
1870 | What are t he core op erating ho urs of the RAMS Help Desk? | |
1871 | 9 a.m. to 6 p.m., ES T, Mon. th rough Fri. | |
1872 | The respon se time of a trouble ticket is dependent upon the severity o f the tick et. | |
1873 | ||
1874 | How soon s hould the system ful ly recover from an o utage? (In cludes Mea n Time to Restore [M TRS]) | |
1875 | Disaster R ecovery wi thin 72 ho urs | |
1876 | Intentiona lly left b lank. | |
1877 | How much d ata will b e restored when outa ge is reco vered? | |
1878 | 100% (cont inuous bac k-up) | |
1879 | Intentiona lly left b lank. | |
1880 | What time period sho uld be con sidered fo r maintena nce period s? | |
1881 | After hour s (these w ould be of f peak hou rs approve d by the O ffice of R esearch an d Developm ent) | |
1882 | Intentiona lly left b lank. | |
1883 | In what st andard tim e zone wil l the syst em operate ? | |
1884 | All time z ones | |
1885 | Intentiona lly left b lank. | |
1886 | Scope Inte gration | |
1887 | Since the primary pu rpose of t he RAMS In tegration is the suc cessful an d efficien t manageme nt of a re search sit e, there s hould be e qual impor tance plac ed on the ability fo r the syst em to inte grate and share data with othe r internal and exter nal system s, as well as the ab ility to a ct autonom ously from outside s ystems, if needed. F or example , Master V eteran Ind ex (MVI) i ntegration for Veter an demogra phic verif ication ma y be impor tant, but the abilit y to captu re and sto re such da ta, in the event tha t interfac e is not o perational , is equal ly importa nt. | |
1888 | In general , these in terfaces s hould be f ully autom ated, but as stated, there sho uld be a l evel of in dependence in the ev ent of sit e connecti vity issue s. All int erfaces, t herefore, are expect ed to be R ESTful and have buil t-in fault tolerance for data exchanges. Security Specificat ions | |
1889 | ||
1890 | The Federa l Informat ion Proces sing Stand ard 199 (F IPS 199), Standards for Securi ty Categor ization of Federal I nformation and Infor mation Sys tems, defi nes the se curity cat egories, s ecurity ob jectives, and impact levels to which Nat ional Inst itute of S tandards a nd Technol ogy (NIST) Special P ublication (SP) 800- 60 Volume 1 Revision 1, maps i nformation types. A FIPS 199 a nalysis wa s complete d for the proposed R AMS applic ation, and it has be en determi ned that t he securit y categori zation is MODERATE i n accordan ce with FI PS 199. Th e tables b elow (for management controls, operation al control s, technic al control s, and pri vacy contr ols, respe ctively) i nclude the relevant references , publicat ions, and directives based on this categ orization: | |
1891 | ||
1892 | Table 14: Security S pecificati ons – Mode rate Impac t Controls | |
1893 | Control Nu mber | |
1894 | Control Na me | |
1895 | Moderate I mpact | |
1896 | VA Guidanc e | |
1897 | AC-1 | |
1898 | ACCESS CON TROL POLIC Y AND PROC EDURES | |
1899 | AC-1 | |
1900 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1901 | AC-2 | |
1902 | ACCOUNT MA NAGEMENT | |
1903 | AC-2 (1) ( 2) (3) (4) | |
1904 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1905 | AC-3 | |
1906 | ACCESS ENF ORCEMENT | |
1907 | AC-3 | |
1908 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1909 | AC-4 | |
1910 | INFORMATIO N FLOW ENF ORCEMENT | |
1911 | AC-4 | |
1912 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1913 | AC-5 | |
1914 | SEPARATION OF DUTIES | |
1915 | AC-5 | |
1916 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1917 | AC-6 | |
1918 | LEAST PRIV ILEGE | |
1919 | AC-6 (1) ( 2) (5) (9) (10) | |
1920 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1921 | AC-7 | |
1922 | UNSUCCESSF UL LOGON A TTEMPTS | |
1923 | AC-7 | |
1924 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1925 | AC-8 | |
1926 | SYSTEM USE NOTIFICAT ION | |
1927 | AC-8 | |
1928 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1929 | AC-11 | |
1930 | SESSION LO CK | |
1931 | AC-11 (1) | |
1932 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1933 | AC-12 | |
1934 | SESSION TE RMINATION | |
1935 | AC-12 | |
1936 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1937 | AC-14 | |
1938 | PERMITTED ACTIONS WI THOUT IDEN TIFICATION OR AUTHEN TICATION | |
1939 | AC-14 | |
1940 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1941 | AC-17 | |
1942 | REMOTE ACC ESS | |
1943 | AC-17 (1) (2) (3) (4 ) | |
1944 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1945 | AC-18 | |
1946 | WIRELESS A CCESS | |
1947 | AC-18 (1) | |
1948 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1949 | AC-19 | |
1950 | ACCESS CON TROL FOR M OBILE DEVI CES | |
1951 | AC-19 (5) | |
1952 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1953 | AC-20 | |
1954 | USE OF EXT ERNAL INFO RMATION SY STEMS | |
1955 | AC-20 (1) (2) | |
1956 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1957 | AC-21 | |
1958 | INFORMATIO N SHARING | |
1959 | AC-21 | |
1960 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1961 | AC-22 | |
1962 | PUBLICLY A CCESSIBLE CONTENT | |
1963 | AC-22 | |
1964 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1965 | AT-1 | |
1966 | SECURITY A WARENESS A ND TRAININ G POLICY A ND PROCEDU RES | |
1967 | AT-1 | |
1968 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1969 | AT-2 | |
1970 | SECURITY A WARENESS T RAINING | |
1971 | AT-2 (2) | |
1972 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1973 | AT-3 | |
1974 | ROLE-BASED SECURITY TRAINING | |
1975 | AT-3 | |
1976 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1977 | AT-4 | |
1978 | SECURITY T RAINING RE CORDS | |
1979 | AT-4 | |
1980 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1981 | AU-1 | |
1982 | AUDIT AND ACCOUNTABI LITY POLIC Y AND PROC EDURES | |
1983 | AU-1 | |
1984 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1985 | AU-2 | |
1986 | AUDIT EVEN TS | |
1987 | AU-2 (3) | |
1988 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1989 | AU-3 | |
1990 | CONTENT OF AUDIT REC ORDS | |
1991 | AU-3 (1) | |
1992 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1993 | AU-4 | |
1994 | AUDIT STOR AGE CAPACI TY | |
1995 | AU-4 | |
1996 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
1997 | AU-5 | |
1998 | RESPONSE T O AUDIT PR OCESSING F AILURES | |
1999 | AU-5 | |
2000 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2001 | AU-6 | |
2002 | AUDIT REVI EW, ANALYS IS, AND RE PORTING | |
2003 | AU-6 (1) ( 3) | |
2004 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2005 | AU-7 | |
2006 | AUDIT REDU CTION AND REPORT GEN ERATION | |
2007 | AU-7 (1) | |
2008 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2009 | AU-8 | |
2010 | TIME STAMP S | |
2011 | AU-8 (1) | |
2012 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2013 | AU-9 | |
2014 | PROTECTION OF AUDIT INFORMATIO N | |
2015 | AU-9 (4) | |
2016 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2017 | AU-11 | |
2018 | AUDIT RECO RD RETENTI ON | |
2019 | AU-11 | |
2020 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2021 | AU-12 | |
2022 | AUDIT GENE RATION | |
2023 | AU-12 | |
2024 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2025 | CA-1 | |
2026 | SECURITY A SSESSMENT AND AUTHOR IZATION PO LICY AND P ROCEDURES | |
2027 | CA-1 | |
2028 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2029 | CA-2 | |
2030 | SECURITY A SSESSMENTS | |
2031 | CA-2 (1) | |
2032 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2033 | CA-3 | |
2034 | SYSTEM INT ERCONNECTI ONS | |
2035 | CA-3 (5) | |
2036 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2037 | CA-5 | |
2038 | PLAN OF AC TION AND M ILESTONES | |
2039 | CA-5 | |
2040 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2041 | CA-6 | |
2042 | SECURITY A UTHORIZATI ON | |
2043 | CA-6 | |
2044 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2045 | CA-7 | |
2046 | CONTINUOUS MONITORIN G | |
2047 | CA-7 (1) | |
2048 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2049 | CA-9 | |
2050 | INTERNAL S YSTEM CONN ECTIONS | |
2051 | CA-9 | |
2052 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2053 | CM-1 | |
2054 | CONFIGURAT ION MANAGE MENT POLIC Y AND PROC EDURES | |
2055 | CM-1 | |
2056 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2057 | CM-2 | |
2058 | BASELINE C ONFIGURATI ON | |
2059 | CM-2 (1) ( 3) (7) | |
2060 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2061 | CM-3 | |
2062 | CONFIGURAT ION CHANGE CONTROL | |
2063 | CM-3 (2) | |
2064 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2065 | CM-4 | |
2066 | SECURITY I MPACT ANAL YSIS | |
2067 | CM-4 | |
2068 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2069 | CM-5 | |
2070 | ACCESS RES TRICTIONS FOR CHANGE | |
2071 | CM-5 | |
2072 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2073 | CM-6 | |
2074 | CONFIGURAT ION SETTIN GS | |
2075 | CM-6 | |
2076 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2077 | CM-7 | |
2078 | LEAST FUNC TIONALITY | |
2079 | CM-7 (1) ( 2) (4) | |
2080 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2081 | CM-8 | |
2082 | INFORMATIO N SYSTEM C OMPONENT I NVENTORY | |
2083 | CM-8 (1) ( 3) (5) | |
2084 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2085 | CM-9 | |
2086 | CONFIGURAT ION MANAGE MENT PLAN | |
2087 | CM-9 | |
2088 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2089 | CM-10 | |
2090 | SOFTWARE U SAGE RESTR ICTIONS | |
2091 | CM-10 | |
2092 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2093 | CM-11 | |
2094 | USER-INSTA LLED SOFTW ARE | |
2095 | CM-11 | |
2096 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2097 | CP-1 | |
2098 | CONTINGENC Y PLANNING POLICY AN D PROCEDUR ES | |
2099 | CP-1 | |
2100 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2101 | CP-2 | |
2102 | CONTINGENC Y PLAN | |
2103 | CP-2 (1) ( 3) (8) | |
2104 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2105 | CP-3 | |
2106 | CONTINGENC Y TRAINING | |
2107 | CP-3 | |
2108 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2109 | CP-4 | |
2110 | CONTINGENC Y PLAN TES TING | |
2111 | CP-4 (1) | |
2112 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2113 | CP-6 | |
2114 | ALTERNATE STORAGE SI TE | |
2115 | CP-6 (1) ( 3) | |
2116 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2117 | CP-7 | |
2118 | ALTERNATE PROCESSING SITE | |
2119 | CP-7 (1) ( 2) (3) | |
2120 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2121 | CP-8 | |
2122 | TELECOMMUN ICATIONS S ERVICES | |
2123 | CP-8 (1) ( 2) | |
2124 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2125 | CP-9 | |
2126 | INFORMATIO N SYSTEM B ACKUP | |
2127 | CP-9 (1) | |
2128 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2129 | CP-10 | |
2130 | INFORMATIO N SYSTEM R ECOVERY AN D RECONSTI TUTION | |
2131 | CP-10 (2) | |
2132 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2133 | IA-1 | |
2134 | IDENTIFICA TION AND A UTHENTICAT ION POLICY AND PROCE DURES | |
2135 | IA-1 | |
2136 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2137 | IA-2 | |
2138 | IDENTIFICA TION AND A UTHENTICAT ION (ORGAN IZATIONAL USERS) | |
2139 | IA-2 (1) ( 2) (3) (8) (11) (12) | |
2140 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2141 | IA-3 | |
2142 | DEVICE IDE NTIFICATIO N AND AUTH ENTICATION | |
2143 | IA-3 | |
2144 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2145 | IA-4 | |
2146 | IDENTIFIER MANAGEMEN T | |
2147 | IA-4 | |
2148 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2149 | IA-5 | |
2150 | AUTHENTICA TOR MANAGE MENT | |
2151 | IA-5 (1) ( 2) (3) (11 ) | |
2152 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2153 | IA-6 | |
2154 | AUTHENTICA TOR FEEDBA CK | |
2155 | IA-6 | |
2156 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2157 | IA-7 | |
2158 | CRYPTOGRAP HIC MODULE AUTHENTIC ATION | |
2159 | IA-7 | |
2160 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2161 | IA-8 | |
2162 | IDENTIFICA TION AND A UTHENTICAT ION (NON-O RGANIZATIO NAL USERS) | |
2163 | IA-8 (1) ( 2) (3) (4) | |
2164 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2165 | IR-1 | |
2166 | INCIDENT R ESPONSE PO LICY AND P ROCEDURES | |
2167 | IR-1 | |
2168 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2169 | IR-2 | |
2170 | INCIDENT R ESPONSE TR AINING | |
2171 | IR-2 | |
2172 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2173 | IR-3 | |
2174 | INCIDENT R ESPONSE TE STING | |
2175 | IR-3 (2) | |
2176 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2177 | IR-4 | |
2178 | INCIDENT H ANDLING | |
2179 | IR-4 (1) | |
2180 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2181 | IR-5 | |
2182 | INCIDENT M ONITORING | |
2183 | IR-5 | |
2184 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2185 | IR-6 | |
2186 | INCIDENT R EPORTING | |
2187 | IR-6 (1) | |
2188 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2189 | IR-7 | |
2190 | INCIDENT R ESPONSE AS SISTANCE | |
2191 | IR-7 (1) | |
2192 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2193 | IR-8 | |
2194 | INCIDENT R ESPONSE PL AN | |
2195 | IR-8 | |
2196 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2197 | MA-1 | |
2198 | SYSTEM MAI NTENANCE P OLICY AND PROCEDURES | |
2199 | MA-1 | |
2200 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2201 | MA-2 | |
2202 | CONTROLLED MAINTENAN CE | |
2203 | MA-2 | |
2204 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2205 | MA-3 | |
2206 | MAINTENANC E TOOLS | |
2207 | MA-3 (1) ( 2) | |
2208 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2209 | MA-4 | |
2210 | NONLOCAL M AINTENANCE | |
2211 | MA-4 (2) | |
2212 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2213 | MA-5 | |
2214 | MAINTENANC E PERSONNE L | |
2215 | MA-5 | |
2216 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2217 | MA-6 | |
2218 | TIMELY MAI NTENANCE | |
2219 | MA-6 | |
2220 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2221 | MP-1 | |
2222 | MEDIA PROT ECTION POL ICY AND PR OCEDURES | |
2223 | MP-1 | |
2224 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2225 | MP-2 | |
2226 | MEDIA ACCE SS | |
2227 | MP-2 | |
2228 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2229 | MP-3 | |
2230 | MEDIA MARK ING | |
2231 | MP-3 | |
2232 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2233 | MP-4 | |
2234 | MEDIA STOR AGE | |
2235 | MP-4 | |
2236 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2237 | MP-5 | |
2238 | MEDIA TRAN SPORT | |
2239 | MP-5 (4) | |
2240 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2241 | MP-6 | |
2242 | MEDIA SANI TIZATION | |
2243 | MP-6 | |
2244 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2245 | MP-7 | |
2246 | MEDIA USE | |
2247 | MP-7 (1) | |
2248 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2249 | PE-1 | |
2250 | PHYSICAL A ND ENVIRON MENTAL PRO TECTION PO LICY AND P ROCEDURES | |
2251 | PE-1 | |
2252 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2253 | PE-2 | |
2254 | PHYSICAL A CCESS AUTH ORIZATIONS | |
2255 | PE-2 | |
2256 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2257 | PE-3 | |
2258 | PHYSICAL A CCESS CONT ROL | |
2259 | PE-3 | |
2260 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2261 | PE-4 | |
2262 | ACCESS CON TROL FOR T RANSMISSIO N MEDIUM | |
2263 | PE-4 | |
2264 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2265 | PE-5 | |
2266 | ACCESS CON TROL FOR O UTPUT DEVI CES | |
2267 | PE-5 | |
2268 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2269 | PE-6 | |
2270 | MONITORING PHYSICAL ACCESS | |
2271 | PE-6 (1) | |
2272 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2273 | PE-8 | |
2274 | VISITOR AC CESS RECOR DS | |
2275 | PE-8 | |
2276 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2277 | PE-9 | |
2278 | POWER EQUI PMENT AND CABLING | |
2279 | PE-9 | |
2280 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2281 | PE-10 | |
2282 | EMERGENCY SHUTOFF | |
2283 | PE-10 | |
2284 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2285 | PE-11 | |
2286 | EMERGENCY POWER | |
2287 | PE-11 | |
2288 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2289 | PE-12 | |
2290 | EMERGENCY LIGHTING | |
2291 | PE-12 | |
2292 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2293 | PE-13 | |
2294 | FIRE PROTE CTION | |
2295 | PE-13 (3) | |
2296 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2297 | PE-14 | |
2298 | TEMPERATUR E AND HUMI DITY CONTR OLS | |
2299 | PE-14 | |
2300 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2301 | PE-15 | |
2302 | WATER DAMA GE PROTECT ION | |
2303 | PE-15 | |
2304 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2305 | PE-16 | |
2306 | DELIVERY A ND REMOVAL | |
2307 | PE-16 | |
2308 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2309 | PE-17 | |
2310 | ALTERNATE WORK SITE | |
2311 | PE-17 | |
2312 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2313 | PL-1 | |
2314 | SECURITY P LANNING PO LICY AND P ROCEDURES | |
2315 | PL-1 | |
2316 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2317 | PL-2 | |
2318 | SYSTEM SEC URITY PLAN | |
2319 | PL-2 (3) | |
2320 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2321 | PL-4 | |
2322 | RULES OF B EHAVIOR | |
2323 | PL-4 (1) | |
2324 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2325 | PL-8 | |
2326 | INFORMATIO N SECURITY ARCHITECT URE | |
2327 | PL-8 | |
2328 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2329 | PS-1 | |
2330 | PERSONNEL SECURITY P OLICY AND PROCEDURES | |
2331 | PS-1 | |
2332 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2333 | PS-2 | |
2334 | POSITION R ISK DESIGN ATION | |
2335 | PS-2 | |
2336 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2337 | PS-3 | |
2338 | PERSONNEL SCREENING | |
2339 | PS-3 | |
2340 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2341 | PS-4 | |
2342 | PERSONNEL TERMINATIO N | |
2343 | PS-4 | |
2344 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2345 | PS-5 | |
2346 | PERSONNEL TRANSFER | |
2347 | PS-5 | |
2348 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2349 | PS-6 | |
2350 | ACCESS AGR EEMENTS | |
2351 | PS-6 | |
2352 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2353 | PS-7 | |
2354 | THIRD-PART Y PERSONNE L SECURITY | |
2355 | PS-7 | |
2356 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2357 | PS-8 | |
2358 | PERSONNEL SANCTIONS | |
2359 | PS-8 | |
2360 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2361 | RA-1 | |
2362 | RISK ASSES SMENT POLI CY AND PRO CEDURES | |
2363 | RA-1 | |
2364 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2365 | RA-2 | |
2366 | SECURITY C ATEGORIZAT ION | |
2367 | RA-2 | |
2368 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2369 | RA-3 | |
2370 | RISK ASSES SMENT | |
2371 | RA-3 | |
2372 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2373 | RA-5 | |
2374 | VULNERABIL ITY SCANNI NG | |
2375 | RA-5 (1) ( 2) (5) | |
2376 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2377 | SA-1 | |
2378 | SYSTEM AND SERVICES ACQUISITIO N POLICY A ND PROCEDU RES | |
2379 | SA-1 | |
2380 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2381 | SA-2 | |
2382 | ALLOCATION OF RESOUR CES | |
2383 | SA-2 | |
2384 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2385 | SA-3 | |
2386 | SYSTEM DEV ELOPMENT L IFE CYCLE | |
2387 | SA-3 | |
2388 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2389 | SA-4 | |
2390 | ACQUISITIO N PROCESS | |
2391 | SA-4 (1) ( 2) (9) (10 ) | |
2392 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2393 | SA-5 | |
2394 | INFORMATIO N SYSTEM D OCUMENTATI ON | |
2395 | SA-5 | |
2396 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2397 | SA-8 | |
2398 | SECURITY E NGINEERING PRINCIPLE S | |
2399 | SA-8 | |
2400 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2401 | SA-9 | |
2402 | EXTERNAL I NFORMATION SYSTEM SE RVICES | |
2403 | SA-9 (2) | |
2404 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2405 | SA-10 | |
2406 | DEVELOPER CONFIGURAT ION MANAGE MENT | |
2407 | SA-10 | |
2408 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2409 | SA-11 | |
2410 | DEVELOPER SECURITY T ESTING AND EVALUATIO N | |
2411 | SA-11 | |
2412 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2413 | SC-1 | |
2414 | SYSTEM AND COMMUNICA TIONS PROT ECTION POL ICY AND PR OCEDURES | |
2415 | SC-1 | |
2416 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2417 | SC-2 | |
2418 | APPLICATIO N PARTITIO NING | |
2419 | SC-2 | |
2420 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2421 | SC-4 | |
2422 | INFORMATIO N IN SHARE D RESOURCE S | |
2423 | SC-4 | |
2424 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2425 | SC-5 | |
2426 | DENIAL OF SERVICE PR OTECTION | |
2427 | SC-5 | |
2428 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2429 | SC-7 | |
2430 | BOUNDARY P ROTECTION | |
2431 | SC-7 (3) ( 4) (5) (7) | |
2432 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2433 | SC-8 | |
2434 | TRANSMISSI ON CONFIDE NTIALITY A ND INTEGRI TY | |
2435 | SC-8 (1) | |
2436 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2437 | SC-10 | |
2438 | NETWORK DI SCONNECT | |
2439 | SC-10 | |
2440 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2441 | SC-12 | |
2442 | CRYPTOGRAP HIC KEY ES TABLISHMEN T AND MANA GEMENT | |
2443 | SC-12 | |
2444 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2445 | SC-13 | |
2446 | CRYPTOGRAP HIC PROTEC TION | |
2447 | SC-13 | |
2448 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2449 | SC-15 | |
2450 | COLLABORAT IVE COMPUT ING DEVICE S | |
2451 | SC-15 | |
2452 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2453 | SC-17 | |
2454 | PUBLIC KEY INFRASTRU CTURE CERT IFICATES | |
2455 | SC-17 | |
2456 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2457 | SC-18 | |
2458 | MOBILE COD E | |
2459 | SC-18 | |
2460 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2461 | SC-19 | |
2462 | VOICE OVER INTERNET PROTOCOL | |
2463 | SC-19 | |
2464 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2465 | SC-20 | |
2466 | SECURE NAM E / ADDRES S RESOLUTI ON SERVICE (AUTHORIT ATIVE SOUR CE) | |
2467 | SC-20 | |
2468 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2469 | SC-21 | |
2470 | SECURE NAM E / ADDRES S RESOLUTI ON SERVICE (RECURSIV E OR CACHI NG RESOLVE R) | |
2471 | SC-21 | |
2472 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2473 | SC-22 | |
2474 | ARCHITECTU RE AND PRO VISIONING FOR NAME / ADDRESS R ESOLUTION SERVICE | |
2475 | SC-22 | |
2476 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2477 | SC-23 | |
2478 | SESSION AU THENTICITY | |
2479 | SC-23 | |
2480 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2481 | SC-28 | |
2482 | PROTECTION OF INFORM ATION AT R EST | |
2483 | SC-28 | |
2484 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2485 | SC-39 | |
2486 | PROCESS IS OLATION | |
2487 | SC-39 | |
2488 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2489 | SI-1 | |
2490 | SYSTEM AND INFORMATI ON INTEGRI TY POLICY AND PROCED URES | |
2491 | SI-1 | |
2492 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2493 | SI-2 | |
2494 | FLAW REMED IATION | |
2495 | SI-2 (2) | |
2496 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2497 | SI-3 | |
2498 | MALICIOUS CODE PROTE CTION | |
2499 | SI-3 (1) ( 2) | |
2500 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2501 | SI-4 | |
2502 | INFORMATIO N SYSTEM M ONITORING | |
2503 | SI-4 (2) ( 4) (5) | |
2504 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2505 | SI-5 | |
2506 | SECURITY A LERTS, ADV ISORIES, A ND DIRECTI VES | |
2507 | SI-5 | |
2508 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2509 | SI-7 | |
2510 | SOFTWARE, FIRMWARE, AND INFORM ATION INTE GRITY | |
2511 | SI-7 (1) ( 7) | |
2512 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2513 | SI-8 | |
2514 | SPAM PROTE CTION | |
2515 | SI-8 (1) ( 2) | |
2516 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2517 | SI-10 | |
2518 | INFORMATIO N INPUT VA LIDATION | |
2519 | SI-10 | |
2520 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2521 | SI-11 | |
2522 | ERROR HAND LING | |
2523 | SI-11 | |
2524 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2525 | SI-12 | |
2526 | INFORMATIO N HANDLING AND RETEN TION | |
2527 | SI-12 | |
2528 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2529 | SI-16 | |
2530 | MEMORY PRO TECTION | |
2531 | SI-16 | |
2532 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2533 | ||
2534 | ||
2535 | Table 15: Security S pecificati ons - Priv acy Contro ls | |
2536 | Control | |
2537 | ID | |
2538 | Privacy Co ntrol Name | |
2539 | VA Guidanc e | |
2540 | AP | |
2541 | Authority and Purpos e | |
2542 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2543 | AP-1 | |
2544 | Authority to Collec t | |
2545 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2546 | AP-2 | |
2547 | Purpose Sp ecificatio n | |
2548 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2549 | AR | |
2550 | Accountabi lity, Audi t, and Ris k Manageme nt | |
2551 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2552 | AR-1 | |
2553 | Governance and Priva cy Program | |
2554 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2555 | AR-2 | |
2556 | Privacy Im pact and R isk Assess ment | |
2557 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2558 | AR-3 | |
2559 | Privacy R equirement s for Cont ractors an d Service Providers | |
2560 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2561 | AR-4 | |
2562 | Privacy M onitoring and Auditi ng | |
2563 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2564 | AR-5 | |
2565 | Privacy Aw areness an d Training | |
2566 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2567 | AR-6 | |
2568 | Privacy Re porting | |
2569 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2570 | AR-7 | |
2571 | Privacy-En hanced Sys tem Design and Devel opment | |
2572 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2573 | AR-8 | |
2574 | Accounting of Disclo sures | |
2575 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2576 | DI | |
2577 | Data Quali ty and Int egrity | |
2578 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2579 | DI-1 | |
2580 | Data Quali ty | |
2581 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2582 | DI-2 | |
2583 | Data Integ rity and D ata Integr ity Board | |
2584 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2585 | DM | |
2586 | Data Minim ization an d Retentio n | |
2587 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2588 | DM-1 | |
2589 | Minimizati on of Pers onal Ident ification Informatio n (PII) | |
2590 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2591 | DM-2 | |
2592 | Data Reten tion and D isposal | |
2593 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2594 | DM-3 | |
2595 | Minimizati on of PII used in Te sting, Tra ining, and Research | |
2596 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2597 | IP | |
2598 | Individual Participa tion and R edress | |
2599 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2600 | IP-1 | |
2601 | Consent | |
2602 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2603 | IP-2 | |
2604 | Individual Access | |
2605 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2606 | IP-3 | |
2607 | Redress | |
2608 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2609 | IP-4 | |
2610 | Complaint Management | |
2611 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2612 | SE | |
2613 | Security | |
2614 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2615 | SE-1 | |
2616 | Inventory of Persona l Identifi cation Inf ormation ( PII) | |
2617 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2618 | SE-2 | |
2619 | Privacy In cident Res ponse | |
2620 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2621 | TR | |
2622 | Transparen cy | |
2623 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2624 | TR-1 | |
2625 | Privacy No tice | |
2626 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2627 | TR-2 | |
2628 | System of Records No tices and Privacy Ac t Statemen ts | |
2629 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2630 | TR-3 | |
2631 | Disseminat ion of Pri vacy Progr am Informa tion | |
2632 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2633 | UL | |
2634 | Use Limita tion | |
2635 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2636 | UL-1 | |
2637 | Internal U se | |
2638 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2639 | UL-2 | |
2640 | Informatio n Sharing with Third Parties | |
2641 | VA Directi ve 6500, V A Handbook 6500, Mar ch 2015, A ppendix C: (Referenc es), Appen dix E: (VA System Pr ivacy Cont rols), App endix F: ( VA System Security C ontrols). | |
2642 | System Fea tures | |
2643 | There are several fe ature sets that the RAMS appli cation wil l encompas s; these c onsist of the follow ing: Resea rch Projec t Manageme nt, Docume nt Managem ent, Perso nnel and F acility Ma nagement, Committee and Commun ications M anagement, and Logis tics Manag ement. Eac h feature set can be further d efined int o more-det ailed subs ets and ul timately t ransformed into the end state Web GUI. | |
2644 | Usability Specificat ions | |
2645 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
2646 | Usability specificat ion requir ements are as outlin ed below: | |
2647 | Table 16: Usability Specificat ion Requir ements | |
2648 | Req. ID | |
2649 | Requiremen t | |
2650 | Priority ( P1, P2, P3 ) | |
2651 | Increment (1, 2, Fut ure) | |
2652 | USA-001 | |
2653 | RAMS shall follow th e Governme nt Usabili ty process as specif ied in the usability .gov websi te http:// usability. gov/method s/process. html | |
2654 | TBD | |
2655 | 1, 2 | |
2656 | USA-002 | |
2657 | RAMS shall follow th e usabilit y testing as specifi ed in the usability. gov websit e http://u sability.g ov/pdfs/ch apter18.pd f | |
2658 | TBD | |
2659 | 1, 2 | |
2660 | USA-003 | |
2661 | RAMS shall follow a User-cente red design (UCD) | |
2662 | TBD | |
2663 | 1, 2 | |
2664 | User Exper ience enco mpasses di rect and i ndirect in teractions between t he User an d the syst em. Improv ing usabil ity over t he prior v ersion is a key requ irement fo r this app lication. The Intern ational Or ganization for Stand ardization (ISO) def ines usabi lity as “t he extent to which a product c an be used by specif ied Users to achieve specified goals wit h effectiv eness, eff iciency, a nd satisfa ction in a specified context o f use” (19 98). | |
2665 | For an opt imal User experience , the syst em must me et the req uirements outlined i n this sec tion, whic h involve attributes of the ap plication and the pr ocess requ ired to ac hieve them . | |
2666 | In order t o improve usability of VA-deve loped or p urchased a pplication s, the fol lowing act ions are r equired: | |
2667 | •In accord ance with the Office of the Na tional Coo rdinator f or Health Informatio n Technolo gy’s Meani ngful Use Stage 2 fi nal ruling , employ a n industry recognize d User-Cen tered Desi gn (UCD) p rocess. Th e methods for UCD ar e well def ined in do cuments an d requirem ents, such as ISO 92 41–11, ISO 13407, IS O 16982, N ational In stitute of Standards and Techn ology Inte ragency Re port 7741, ISO/Inter national E lectrochem ical Commi ssion 6236 6, and ISO 9241-210. Developer s will cho ose their UCD approa ch; one or more spec ific UCD p rocesses w ill not be prescribe d. | |
2668 | •Adhere to an indust ry-recogni zed User I nterface ( UI) Best P ractices G uideline o r Style Gu ide. For e xample, fi rst follow UI guidel ines for t he develop ment platf orm. In in stances wh ere platfo rm guideli nes are no t availabl e, adhere to the VA Best Pract ices Guide lines/Styl e Guide. | |
2669 | •Inform re quirements and desig ns with de tailed hum an factors work prod ucts that have been/ will be co mpleted fo r the spec ific proje ct. Exampl es of spec ific human factors a ctivities might incl ude heuris tic evalua tions, sit e visits, interviews , applicat ion-specif ic design guides, an d usabilit y testing on existin g systems or prototy pes. | |
2670 | A sound UC D and deve lopment pr ocess base d on human factors s hould incl ude the fo llowing ac tivities: | |
2671 | •Understan ding of th e Users, t he Users’ tasks, and the Users ’ environm ents | |
2672 | •Review of similar o r competit ive system s to infor m requirem ents and d esign | |
2673 | •Heuristic evaluatio n of prior versions, prototype s, or base line appli cations, i f applicab le | |
2674 | •Iterative design an d formativ e usabilit y testing (formative usability testing i s used to discover u sability p roblems du ring the d esign and developmen t process) | |
2675 | •User risk analysis | |
2676 | •Summative validatio n usabilit y testing (summative usability testing i s used to quantify a nd validat e usabilit y of a pro duct with measures o f effectiv eness, eff iciency, U ser percep tions, etc .) | |
2677 | To demonst rate high usability, the appli cation sho uld be: | |
2678 | Intuitive and easy t o learn, w ith minima l training ; | |
2679 | Effective by allowin g Users to successfu lly comple te tasks; | |
2680 | Efficient by allowin g Users to complete their work in a mann er consist ent with c linical pr actice and workflow; | |
2681 | Perceived to have hi gh usabili ty, as dem onstrated by appropr iate surve y measures ; and | |
2682 | Designed t o aid User s in meeti ng task go als withou t being an additiona l burden. | |
2683 | The system must be r eliable an d enable U ser trust by providi ng: | |
2684 | •Stable an d reliable performan ce; | |
2685 | •Accurate data; | |
2686 | •Display o f all data that is a vailable i n native o r interfac ed systems and inten ded to be available in the app lication; and | |
2687 | •Accessibl e informat ion relate d to the s ource of d ata. | |
2688 | The applic ation shou ld include a modern GUI that a llows the User to vi ew data fr om multipl e sources and includ es: | |
2689 | •Integrate d display of structu red and un structured data; | |
2690 | •Rich data visualiza tion and g raphical d isplay of data; | |
2691 | •Ability t o switch b etween tab ular and g raphical d ata views; | |
2692 | •Ability t o interact with disp layed data to obtain additiona l details related to the data and source of the da ta; and | |
2693 | •User cust omizable c omponents and settin gs. | |
2694 | The applic ation must provide f or advance d and up-t o-date sea rching, to include: | |
2695 | •Fast sear ch functio nality wit h auto-com plete and real-time display of matched r esults dur ing typing ; and | |
2696 | •Search hi story. | |
2697 | The applic ation must provide f or advance d filterin g capabili ties, to i nclude: | |
2698 | •Filtering of data t ables, lis ts, and gr ids; and | |
2699 | •Filtering of search results. | |
2700 | The applic ation desi gn should be modifie d to: | |
2701 | •Address t he specifi c findings from a hu man factor heuristic evaluatio n conducte d on the p rior versi on of the applicatio n; | |
2702 | •Address t he specifi c findings reported from field use of th e prior ve rsion; and | |
2703 | •Address t he specifi c findings reported from usabi lity testi ng of the prior vers ion or rel evant prot otypes. | |
2704 | The follow ing table outlines t he usabili ty/User in terface re quirements for the R AMS Integr ation. | |
2705 | Table 17: Usability/ User Inter face Requi rements | |
2706 | Identifier | |
2707 | Usability/ User Inter face Requi rements | |
2708 | No identif ier provid ed in BRD. | |
2709 | Left align content i n table ce lls to fac ilitate qu ick visual scan. | |
2710 | No identif ier provid ed in BRD. | |
2711 | Left align text for column hea ders to fa cilitate v isual scan and make columns an d content appear mor e organize d. | |
2712 | No identif ier provid ed in BRD. | |
2713 | Use mixed case inste ad of all caps whene ver possib le (e.g., dropdown l ist items, table dat a, table h eaders, hy perlinks, tab names) . Limit th e use of “ all caps” throughout the appli cation. | |
2714 | No identif ier provid ed in BRD. | |
2715 | Simplify b utton labe ls. Re-lab el buttons to reflec t standard terminolo gy that is common in web inter faces and other appl ications ( e.g., “Can cel”). Emp hasize the action be ing perfor med in the most succ inct way p ossible. M inimize re dundancy i n text/ter minology t hat is use d to conve y the same action. | |
2716 | No identif ier provid ed in BRD. | |
2717 | Left align page/sect ion titles to anchor titles in consisten t location s regardle ss of wind ow sizing. | |
2718 | No identif ier provid ed in BRD. | |
2719 | Labels for fields sh ould be le ft aligned to facili tate quick visual sc an and mak e forms an d field gr oupings ap pear more organized. | |
2720 | No identif ier provid ed in BRD. | |
2721 | Avoid usin g acronyms or abbrev iations un less (a) t hey are wi dely under stood/well known or (b) there is very li mited spac e to displ ay the ful l meaning. This supp orts naïve User unde rstanding. If limite d space re sults in u sing a non -common ac ronym/abbr eviation, ensure it is specifi ed within “Help” and /or as a t ooltip. | |
2722 | No identif ier provid ed in BRD. | |
2723 | Use colors such as r ed and gre en only fo r status d riven cont ent. Avoid using red for text/ content, l inks, butt on labels, etc. This will redu ce risk fo r User err or, improv e link dis coverabili ty, and fa cilitate u nderstandi ng of diff erences in navigatio n/actions/ content. I t will als o help Use rs to isol ate import ant status informati on (using red, green , etc.) fr om other l ess import ant inform ation when viewing a nd process ing inform ation prov ided to th em on a pa ge. | |
2724 | No identif ier provid ed in BRD. | |
2725 | Provide vi sual separ ation betw een the na vigation s pace and t he main co ntent area . | |
2726 | No identif ier provid ed in BRD. | |
2727 | Add field level vali dation and notificat ion of mis sing infor mation on the same p age withou t launchin g a new wi ndow or na vigating t o another page. | |
2728 | No identif ier provid ed in BRD. | |
2729 | Make all t ext hyperl inks appea r consiste nt in styl e. | |
2730 | No identif ier provid ed in BRD. | |
2731 | Make drop- down selec tion box w idths appr opriate fo r content and visual appeal. | |
2732 | No identif ier provid ed in BRD. | |
2733 | Use standa rd and alw ays visibl e radio bu ttons for “Yes/No” o ptions ins tead of re quiring th e User to click in a drop down box and t hen click to select the “Yes” or “No” op tion. | |
2734 | No identif ier provid ed in BRD. | |
2735 | Use standa rd date an d time sel ection wid gets. Wher e date and time are selected/p icked from a standar d widget, also provi de direct data entry to suppor t keyboard navigatio n. Enable field leve l validati on immedia tely upon entry. Inc lude instr uctional f ormat text within th e field en try box. | |
2736 | No identif ier provid ed in BRD. | |
2737 | Provide st andard sor t behavior and visua l indicati ons on col umns in al l tables. | |
2738 | No identif ier provid ed in BRD. | |
2739 | Define and adhere to a standar d model fo r use and design of controls, buttons, h yperlinks, and navig ation elem ents. | |
2740 | No identif ier provid ed in BRD. | |
2741 | Ensure tha t text is sized to b e readable (for exam ple, by us ing the 00 7 Rule to assure tex t size is readable f or Users w ith 20/40 vision. Th e formula: Text heig ht = .007 * distance between e yes and sc reen). | |
2742 | No identif ier provid ed in BRD. | |
2743 | Place comm on navigat ion elemen ts in cons istent loc ations. | |
2744 | No identif ier provid ed in BRD. | |
2745 | Place crit ical infor mation “ab ove the fo ld” (i.e., in the to p portion of the scr een that i s immediat ely viewab le). | |
2746 | No identif ier provid ed in BRD. | |
2747 | Use consis tent scree n flow mod els, eleme nts, and t erms to su pport simi lar workfl ows. | |
2748 | No identif ier provid ed in BRD. | |
2749 | Use consis tently nam ed buttons when acti ons are th e same (e. g., Add, v s. Save, v s. Submit) . | |
2750 | No identif ier provid ed in BRD. | |
2751 | Enable Use rs to prin t views fr om where t hey are in the inter face. Avoi d requirin g the User to “run a report” i n order to print som ething tha t is viewa ble on the screen. | |
2752 | No identif ier provid ed in BRD. | |
2753 | Provide fi eld entry tool tips at the fie ld locatio n. Ensure consistenc y across t he applica tion in fi eld labels , formats, location of tool ti ps, and to ol tip tex t. | |
2754 | No identif ier provid ed in BRD. | |
2755 | Provide vi sual indic ation of r equired fi elds. | |
2756 | No identif ier provid ed in BRD. | |
2757 | Display fi eld labels in close proximity to entry e lements. | |
2758 | No identif ier provid ed in BRD. | |
2759 | Use consis tent eleme nts to fil ter data. | |
2760 | No identif ier provid ed in BRD. | |
2761 | Use consis tent eleme nts to sor t data. | |
2762 | No identif ier provid ed in BRD. | |
2763 | Use a cons istent mod el for dis play, layo ut, and gr ouping of data entry fields. | |
2764 | No identif ier provid ed in BRD. | |
2765 | Provide al ternate ro w shading in lengthy tables of data, for m elements , etc. | |
2766 | No identif ier provid ed in BRD. | |
2767 | Ensure tha t icons ar e recogniz ed by User s. | |
2768 | No identif ier provid ed in BRD. | |
2769 | Provide so me “white space” bet ween statu s icons in report vi ews, white board vie ws, etc. | |
2770 | No identif ier provid ed in BRD. | |
2771 | Auto-popul ate defaul t values i n entry/se lection fi elds when possible a nd appropr iate. | |
2772 | No identif ier provid ed in BRD. | |
2773 | Visually d ifferentia te status icons from clickable icons, wh en appropr iate. | |
2774 | No identif ier provid ed in BRD. | |
2775 | Define and support t he appropr iate User tab sequen ce through fields in forms in order to s upport key board navi gation whe n entering data in f orms. | |
2776 | No identif ier provid ed in BRD. | |
2777 | Define and adhere to standard action but ton placem ent on scr eens, form s, etc. | |
2778 | No identif ier provid ed in BRD. | |
2779 | Visually d istinguish the prima ry action button on a page. | |
2780 | No identif ier provid ed in BRD. | |
2781 | Consistent ly use scr een elemen ts, action elements, workflow sequences within/acr oss screen s, languag e, etc. | |
2782 | No identif ier provid ed in BRD. | |
2783 | Provide er ror messag es in User -centric l anguage wi th specifi c instruct ions on th e meaning of the err or and how to recove r from it. Use error messages and method of displa y consiste ntly acros s the inte rface. | |
2784 | No identif ier provid ed in BRD. | |
2785 | Provide co ntext-spec ific Help. | |
2786 | No identif ier provid ed in BRD. | |
2787 | Do not use the term “sex” or a ny like ab breviation s to repre sent gende r. | |
2788 | Purchased Components | |
2789 | No compone nts have b een purcha sed specif ically for RAMS. RAM S uses ent erprise li censes for all softw are compon ents. | |
2790 | Estimation | |
2791 | Informatio n for the estimation is not av ailable at this time . The RAMS Integrati on Milesto ne 1 (MS1) Review wi ll not be until July 2016. To receive fu nction poi nt analysi s results, the follo wing detai ls will ha ve to be s ubmitted t o EM A
|
|
2792 | The name o f the proj ect as it appears in the Proje ct Managem ent Accoun tability S ystem (PMA S) | |
2793 | The increm ent Number and Type (delivery, IOC, depl oyment, vi sibility, and monito ring) | |
2794 | The correc t Enterpri se Project Structure (EPS) num ber | |
2795 | The date o f MS1 revi ew | |
2796 | Link to th e function al specifi cations th at list an d describe all of th e function al User re quirements for that increment (BRD, RSD, SDD, User Stories, Use Cases, etc.) | |
2797 | ||
2798 | ||
2799 | Project So ftware Fun ctional Si ze and Siz e-Based Ef fort and D uration Es timate | |
2800 | Applicatio n | |
2801 | Item | |
2802 | A | |
2803 | B | |
2804 | C | |
2805 | D | |
2806 | E | |
2807 | Total | |
2808 | Counted Fu nction Poi nts | |
2809 | ||
2810 | ||
2811 | ||
2812 | ||
2813 | ||
2814 | ||
2815 | Estimated Scope Grow th | |
2816 | ||
2817 | ||
2818 | ||
2819 | ||
2820 | ||
2821 | ||
2822 | Estimated Size at Re lease | |
2823 | ||
2824 | ||
2825 | ||
2826 | ||
2827 | ||
2828 | ||
2829 | ||
2830 | Size-Based Effort Es timates | |
2831 | Labor Hour s | |
2832 | Probabilit y | |
2833 | Low-Effort Estimate – With ind icated pro bability, project wi ll consume no more t han: | |
2834 | ||
2835 | ||
2836 | High-Effor t Estimate – With in dicated pr obability, project w ill consum e no more than: | |
2837 | ||
2838 | ||
2839 | ||
2840 | Size-Based Duration Estimates | |
2841 | Work Days | |
2842 | Probabilit y | |
2843 | Low-Durati on Estimat e – With i ndicated p robability , project will consu me no more than: | |
2844 | ||
2845 | ||
2846 | High-Durat ion Estima te -- With indicated probabili ty, projec t will con sume no mo re than: | |
2847 | ||
2848 | ||
2849 | ||
2850 | Figure 1: Cumulative Probabili ty (“S-cur ve”) Chart | |
2851 | [Insert Cu mulative P robability (“S-curve ”) Charts here] | |
2852 | ||
2853 | Approval S ignatures | |
2854 | REVIEW DAT E: Februar y 5, 2016 | |
2855 | SCRIBE: Pa ul Bockewi tz | |
2856 | Signed: | |
2857 | __________ __________ __________ __________ __________ __________ __________ ________ | |
2858 | Glenda Mil ler, Integ rated Proj ect Team ( IPT) Chair Date | |
2859 | __________ __________ __________ __________ __________ __________ __________ ________ | |
2860 | James Bree ling, M.D. , Business Sponsor D ate | |
2861 | __________ __________ __________ __________ __________ __________ __________ ________Ma risue Cody , Ph.D., B usiness Ow nerDate | |
2862 | __________ __________ __________ __________ __________ __________ __________ ________To by Rudik, IT Program ManagerDa te | |
2863 | __________ __________ __________ __________ __________ __________ __________ ________ | |
2864 | Glenda Mil ler, Proje ct Manager Date | |
2865 | ||
2866 | Appendix A : Non-Func tional Req uirements | |
2867 | The follow ing non-fu nctional r equirement s should b e reviewed and acces sed while developing the requi rements fo r the proj ect. | |
2868 | System Per formance R eporting R equirement s | |
2869 | The existi ng non-sta ndard arch itecture h as led to inconsiste nt data ma nagement p rocesses a cross the national p rogram. Th is has als o resulted in delays when resp onding to Central Of fice initi ated data calls. | |
2870 | Each field research office mus t be in co mpliance w ith Federa l and indu stry regul ations. In the absen ce of an e nterprise solution t he field o ffices exp end excess ive local resources to track c ritical da ta for ong oing proje cts to ens ure that t hey are me eting all of the req uirements of the law . In the a bsence of a uniform, standardi zed softwa re solutio n, both OR D and our field rese arch offic es will co ntinue to experience limited a bility to efficientl y respond to Congres sional and Secretary level inq uiries, re view progr ess of res earch port folios to address cu rrent and future VA research n eeds and m eet VA and industry mandated c ompliance reporting requiremen ts. | |
2871 | In order t o operate effectivel y, each fi eld resear ch office must be in complianc e with the Common Ru le, United States De partment o f Agricult ure Animal Welfare A ct Regulat ions, Occu pational S afety and Health Adm inistratio n guidelin es, Enviro nmental Pr otection A gency guid elines, an d all pert inent VA r egulations , includin g pharmacy , bio-safe ty, occupa tional hea lth, and h uman resou rce manage ment. Thes e offices use a vari ety of sub ject matte r expert ( SME) commi ttees. In the absenc e of an en terprise s olution, t he field o ffices exp end excess ive resour ces to tra ck the sta tus of eac h ongoing project an d all of t he personn el involve d in each project to ensure th at they ar e meeting all of the requireme nts of the law. | |
2872 | We rely on our inves tigators i n the fiel d to provi de twenty- first cent ury, trans formationa l research , in which VA takes great prid e. In the absence of a system- wide resea rch office managemen t and repo rting tool , ORD and our field research o ffices wil l continue to experi ence limit ed ability to effici ently resp ond to Con gressional - and Secr etary-leve l inquirie s, review progress o f research portfolio s to addre ss current and futur e VA resea rch needs, and meet VA and ind ustry-mand ated compl iance repo rting requ irements. | |
2873 | Listed bel ow is Busi ness Need 6, The Cen tral Offic e Reportin g Requirem ents: | |
2874 | Table 18: Reporting Requiremen ts | |
2875 | BN6 | |
2876 | Central Of fice Repor ting Requi rements | |
2877 | Priority | |
2878 | 6.1 | |
2879 | Create rea l-time exp enditure r eports. | |
2880 | Medium pri ority | |
2881 | 6.2 | |
2882 | Provide qu ery and re porting to ols for | |
2883 | administra tive resea rch data. | |
2884 | High prior ity | |
2885 | 6.3 | |
2886 | Define por tfolio rep orting cat egories of funded re search pro jects, wit h tools fo r administ rate resea rch data. | |
2887 | Completed in an alte rnative pr oject | |
2888 | 6.4 | |
2889 | Support 20 0+ pre-def ined categ ories from the | |
2890 | NIH. | |
2891 | Completed in an alte rnative | |
2892 | project | |
2893 | 6.5 | |
2894 | Support VA -specific portfolio categories . | |
2895 | Completed in an alte rnative | |
2896 | project | |
2897 | 6.6 | |
2898 | Ability to individua lly re-wei ght concep ts in any category t o meet exp ectations | |
2899 | Completed in an alte rnative | |
2900 | project | |
2901 | 6.7 | |
2902 | Screen inc oming prop osals agai nst simila r applicat ions in ex isting por tfolios of VA, NIH, and other funding in stitutions . | |
2903 | Completed in an alte rnative pr oject | |
2904 | 6.8 | |
2905 | Generate i nternal an d external reviewer profiles b ased on pu blished re search dat a | |
2906 | Completed in an alte rnative | |
2907 | project | |
2908 | 6.9 | |
2909 | Ability to categoriz e internal and exter nal review er profile s based on known con cepts. | |
2910 | Completed in an alte rnative | |
2911 | project | |
2912 | 6.10 | |
2913 | Automatic detection of conflic ts of inte rest betwe en incomin g proposal and revie wer profil es. | |
2914 | Completed in an alte rnative | |
2915 | project | |
2916 | 6.11 | |
2917 | Ability to compare i ncoming pr oposals to internal and extern al reviewe r profiles . | |
2918 | Completed in an alte rnative pr oject | |
2919 | 6.12 | |
2920 | Export raw data in X ML which c an be anal yzed with third-part y business intellige nce, analy sis and vi sualizatio n tools. | |
2921 | High prior ity | |
2922 | ||
2923 | Operationa l Environm ent Requir ements | |
2924 | System res ponse time s and page load time s shall be consisten t with PIT C Enterpri se standar ds. | |
2925 | Maintenanc e, includi ng mainten ance of ex ternally d eveloped s oftware in corporated into the RAMS appli cation, sh all be sch eduled dur ing off pe ak hours o r in conju nction wit h relevant maintenan ce schedul es. The bu siness own er should provide sp ecific req uirements for establ ishing sys tem mainte nance wind ows when p lanned ser vice disru ptions can occur in support of periodic maintenanc e. | |
2926 | Informatio n about re sponse tim e degradat ion result ing from u nscheduled system ou tages and other even ts that de grade syst em functio nality and /or perfor mance shal l be disse minated to the User community within 30 minutes of the occur rence. The notificat ion shall include th e informat ion descri bed in the current A utomated N otificatio n Reportin g (ANR) te mplate mai ntained by the VA Se rvice Desk . The spec ific busin ess impact must be n oted in or der for OI T to provi de accurat e data in the servic e impact n otice of t he ANR. | |
2927 | Provide a real-time monitoring solution to report agreed/ide ntified cr itical sys tem perfor mance para meters. | |
2928 | Critical b usiness pe rformance parameters shall be identified , e.g., tr ansaction speed, res ponse time for scree n display/ refresh, d ata retrie val, etc., in a mann er that da ta capture can occur to suppor t metric r eporting a nd support the OI&T performanc e dashboar d display. If no suc h performa nce metric s are requ ired or pr ovided, th ere will b e no progr am specifi c Service Level Agre ements (SL A) created , nor shal l there be any activ e/real tim e monitori ng through OI&T Perf ormance Da shboard to provide t he busines s owners a ny perform ance metri cs. | |
2929 | Notificati on of sche duled main tenance pe riods that require t he service to be off line or th at may deg rade syste m performa nce shall be dissemi nated to t he busines s User com munity a m inimum of 48 hours p rior to th e schedule d event. | |
2930 | Documentat ion Requir ements | |
2931 | The traini ng curricu lum shall state the expected t raining ti me for pri mary Users and secon dary Users to become proficien t at using the RAMS applicatio n. | |
2932 | All traini ng curricu la, User m anuals, an d other tr aining too ls shall b e develope d/updated by ORD or Collaborat ive Instit utional Tr aining Ini tiative an d delivere d to all l evels of U sers. The curricula shall incl ude all as pects of t he new fun ctionality of the RA MS applica tion and a ll changes to proces ses and pr ocedures. | |
2933 | The traini ng curricu lum develo ped by the Program O ffice shal l state th e expected task comp letion tim e for prim ary and se condary Us ers. | |
2934 | User manua ls and tra ining tool s shall be developed . If they already ex ist, updat es shall b e made to them, as n ecessary, and they s hall be de livered to all level s of Users . | |
2935 | IT will pr ovide the level of d ocumentati on require d to suppo rt the sys tem and ma intain ope rations an d continui ty. Docume ntation sh all repres ent minima l programm atic and l ifecycle o perations support do cumentatio n artifact s as defin ed by VA s tandards i n ProPath and as req uired by t he VA Ente rprise Sys tem Engine ering Life cycle and Release Ma nagement o ffice for sustained operations , maintena nce, and s upport pri or to appr oval by an y VA chang e control board and release in to product ion. | |
2936 | Implementa tion Requi rements | |
2937 | As part of the syste m implemen tation pro cess, a de tailed RAC I (R – Res ponsible, A- Account able, C – Consulted, I – Infor med) Matri x will be created to identify all areas addressed in the OM Plan and s how specif ic roles a nd respons ibilities by environ ment. Once developed , this det ailed matr ix will be added as an attachm ent to thi s OM Plan. | |
2938 | The follow ing is a l ist of Imp lementatio n Requirem ents | |
2939 | There is a need to t rain the t argeted st aff groups on the ne w function ality. | |
2940 | Early iden tification of subjec t matter e xperts and test site s required to succes sfully def ine the ma ster test strategy, the deploy ment plan, and the i mplementat ion plan. | |
2941 | Close coor dination w ith OIT is required in order t o ensure b usiness re quirements are met a nd deploym ent plans are aligne d. | |
2942 | Data Prote ction/Back -up/Archiv e Requirem ents | |
2943 | The system shall ens ure a back -up and da ta recover y process is availab le for whe n the syst em is brou ght off-li ne for mai ntenance o r technica l issues/p roblems. | |
2944 | The system shall ens ure data p rotection measures, such as ba ck-up inte rvals and redundancy shall be consistent with syst ems catego rized as r outine (30 day resto ration), m ission ess ential (72 hour rest oration), or mission critical (12 hour r estoration ). | |
2945 | Business o wners are required t o state th e mission criticalit y of the I T services required in order t o assist t he planner s and deve lopers in determinin g best str ategies fo r engineer ing an IT solution t o meet the ir busines s objectiv es/needs. The busine ss owner n eeds to st ate the cr iticality of the dat a and the impact to the busine ss during a service disruption so approp riate tech nologies c an be cons idered. | |
2946 | Levels for Disaster Recovery | |
2947 | Classifica tionRecove ry Time Ob jectiveRec overy Poin t | |
2948 | Objective Routine30 day restor ationTBD | |
2949 | Mission Es sential72 hour resto ration24 h ours | |
2950 | Mission Cr itical12 h our restor ation2 hou rs | |
2951 | Recovery T ime Object ive (RTO) – RTO defi nes the ma ximum amou nt of time that a sy stem resou rce can re main unava ilable bef ore there is an unac ceptable i mpact on o ther syste m resource s, support ed mission /business processes, and the M TD. | |
2952 | Maximum To lerable Do wntime (MT D) - The M TD represe nts the to tal amount of time t he system owner/auth orizing of ficial is willing to accept fo r a missio n/business process o utage or d isruption and includ es all imp act consid erations. | |
2953 | Recovery P oint Objec tive (RPO) - The RPO represent s the poin t in time, prior to a disrupti on or syst em outage, to which mission/bu siness pro cess data can be rec overed (gi ven the mo st recent backup cop y of the d ata) after an outage . | |
2954 | Table 19: Data Prote ction Requ irements | |
2955 | SLR Questi on | |
2956 | SLR Criter ia | |
2957 | How much t ime should the syste m be avail able (and how much d own time i s acceptab le due to incident [ unexpected ] outage)? | |
2958 | 99.9% (8.7 6 hours do wn time) | |
2959 | When shoul d the syst em be avai lable (wha t will be the core o perating h ours of th e system)? | |
2960 | 8 a.m. to 8 p.m., ES T, Mon. th rough | |
2961 | Fri. | |
2962 | How soon s hould the system ful ly recover from an o utage? (In cludes Mea n Time to Restore [M TRS]) | |
2963 | Disaster R ecovery wi thin 72 ho urs | |
2964 | How much d ata will b e restored when outa ge is reco vered? | |
2965 | 100% (cont inuous bac k-up) | |
2966 | What time period sho uld be con sidered fo r maintena nce period s? | |
2967 | After hour s (these w ould be of f peak hou rs approve d by the O ffice of R esearch an d Developm ent) | |
2968 | What stand ard time z one will t he system operate in ? | |
2969 | All time z ones | |
2970 | Data Quali ty/Assuran ce Require ments | |
2971 | A monitori ng process shall be provided t o ensure t hat data i s accurate and up-to -date and provides a ccurate al erts for m alfunction s while mi nimizing f alse alarm s. | |
2972 | User Acces s/Security Requireme nts | |
2973 | Ensure the proposed solution m eets all V eterans He alth Admin istration (VHA) Secu rity, Priv acy, and I dentity Ma nagement r equirement s, includi ng VA Hand book 6500 (see the E nterprise Requiremen ts section of the RT M). | |
2974 | Table 20: User Acces s/Security Requireme nts | |
2975 | User Level | |
2976 | Role | |
2977 | Responsibi lities | |
2978 | RAMS Acces s Level | |
2979 | Administra tive Offic er | |
2980 | Senior ORD official at each re search sta tion | |
2981 | Administra tive funct ions of th e research program - | |
2982 | All commit tees | |
2983 | Read/Write | |
2984 | Associate Chief of S taff for R esearch | |
2985 | Chief Oper ational Of ficer for the resear ch station | |
2986 | Oversees c ommittees and subcom mittees an d responsi ble for co ordination with audi t agencies , as well as day to day manage ment of th e research program a t faciliti es with la rge active programs - All com mittees | |
2987 | Read/Write | |
2988 | Committee Coordinato r/ Committ ee Adminis trator | |
2989 | Manages al l activiti es of the committee | |
2990 | Communicat ion with P rinciple I nvestigato rs, assign ment of pr ojects to agendas, m inutes, co ordinator of reviewe r comments , scheduli ng meeting s, trackin g committe e members, and quoru ms - All c ommittees | |
2991 | ||
2992 | TBD | |
2993 | Principal Investigat or | |
2994 | Directs re search pro ject or pr ogram | |
2995 | Oversees s cientific, technical , and day- to-day man agement of the resea rch and is leader of research team - All committee s | |
2996 | Read/Write | |
2997 | Principal Investigat or Designe e | |
2998 | Assists in preparati on of proj ect/protoc ol | |
2999 | Completes entry of c omponents associated with the protocol, submits to IRB - All committee s | |
3000 | TBD | |
3001 | Co-Princip al Investi gator | |
3002 | Similar to Principal Investiga tor | |
3003 | Ensures pr oject is c onducted i n complian ce with ap plicable l aws and re gulations and instit utional po licy - All committee s | |
3004 | Read/Write | |
3005 | IRB Admini strator | |
3006 | Conducts r eview proc ess for co nsideratio ns | |
3007 | Reviews fo r issues, such as co nflicts of interest, initial r eview of d isclosure forms, det ermines wh ether refe rrals are needed to specific c ommittees - All comm ittees | |
3008 | TBD | |
3009 | IRB Chair | |
3010 | Determines if an app lication i s complete | |
3011 | Determines if applic ation lack s any disq ualifying features a nd forward s all appl ication ma terials to members o f IRB Comm ittee - Al l committe es | |
3012 | TBD | |
3013 | IRB Member | |
3014 | A member o f IRB | |
3015 | Member of an elected board or other grou p formally designate d by an in stitution to review, approve, require mo dification in, disap prove, and conduct c ontinuing oversight of human r esearch in accordanc e with law s and regu lations - All commit tees | |
3016 | TBD | |
3017 | IRB Staff | |
3018 | Assists th e Administ rative Off icer, IRB Chair in a dministrat ive functi ons | |
3019 | Performs a dministrat ive functi ons. - All committee s | |
3020 | TBD | |
3021 | Local Site Investiga tor (CIRB Role Only) | |
3022 | Investigat or at site participa ting in a multi-site research study | |
3023 | Oversees s cientific, technical , and day- to-day man agement of the resea rch at a l ocal site | |
3024 | TBD | |
3025 | Local RAMS Administr ator | |
3026 | User with special pr ivileges t o establis h and main tain local User acco unts | |
3027 | Administra tive funct ions - All committee s | |
3028 | Read/Write | |
3029 | Study Coor dinator | |
3030 | Specialize d research coordinat or working under dir ection of the Princi ple Invest igator | |
3031 | Facilitate s the dail y trial ac tivities a nd conduct of the st udy, repor ts with ad ministrati ve, scient ific propo sal prepar ation and review, bu dget, awar d acceptan ce, etc. - All commi ttees | |
3032 | TBD | |
3033 | ORD Admini strator | |
3034 | Determines whether o r not a gi ven projec t is a can didate for review by the VA Ce ntral IRB | |
3035 | Administra tive VA Ce ntral IRB support. | |
3036 | TBD | |
3037 | ||
3038 | Usability/ User Inter face Requi rements | |
3039 | Adhere to good User Interface/ User Cente red Design (UI/UCD) principles as outlin ed in the Usability Appendix o f the BRD. Additiona l informat ion is ava ilable in Section 2. 15 of this document. | |
3040 | Conceptual Integrity | |
3041 | The system shall pro vide stand ards-based messaging and middl eware infr astructure needed to support R AMS deploy ment. | |
3042 | Availabili ty | |
3043 | Maintenanc e window, including maintenanc e of exter nally deve loped soft ware incor porated in to the RAM S applicat ion, will be by mutu al agreeme nt between OI&T and the VHA Po int of Con tact (POC) for the a ffected fa cility(ies ). VHA wil l provide POCs for e ach facili ty. | |
3044 | The RAMS a pplication unavailab ility, due to an unp lanned out age or pla nned outag es that ex ceed the d efined mai ntenance w indow, wil l not exce ed 8.76 ho urs per ye ar and wil l not exce ed 43.8 mi nutes per month (99. 9% availab ility). | |
3045 | The applic ation shal l be avail able 24 ho urs a day, seven day s a week, with an up time of 99 .9%. | |
3046 | All system updates a nd schedul ed mainten ance shoul d occur be tween the hours of 1 800 and 06 00 (per lo cal time z one), when clinical usage woul d be light est. | |
3047 | Table 21: Availabili ty | |
3048 | SLR Questi on | |
3049 | SLR Criter ia | |
3050 | How much t ime should the syste m be avail able (and how much d own time i s acceptab le due to incident [ unexpected ] outage)? | |
3051 | 99.9% (8.7 6 hours do wn time) | |
3052 | When shoul d the syst em be avai lable (wha t will be the core o perating h ours of th e system)? | |
3053 | 8 a.m. to 8 p.m., ES T, Mon. th rough | |
3054 | Fri. | |
3055 | How soon s hould the system ful ly recover from an o utage? (In cludes Mea n Time to Restore [M TRS]) | |
3056 | Disaster R ecovery wi thin 72 ho urs | |
3057 | How much d ata will b e restored when outa ge is reco vered? | |
3058 | 100% (cont inuous bac k-up) | |
3059 | What time period sho uld be con sidered fo r maintena nce period s? | |
3060 | After hour s (these w ould be of f-peak hou rs approve d by the O ffice of R esearch an d Developm ent) | |
3061 | In what st andard tim e zone wil l the syst em operate ? | |
3062 | All time z ones | |
3063 | Table 22: Goal/Objec tive | |
3064 | Goal/Objec tive | |
3065 | Desired Ou tcome | |
3066 | Measuremen t | |
3067 | Impact | |
3068 | Provide a centralize d enterpri se-level r epository of nationa l VA resea rch office program d ata. | |
3069 | All VHA na tional res earch prog ram admini strative d ata is sto red in a c entral dat abase and accessible by a comm on tool se t, at appr opriate le vels, to a ll researc h program stakeholde rs. | |
3070 | The centra lized data repositor y is avail able by we b connecti on to all VA researc h offices and stakeh olders loc ated at Ce ntral Offi ce. | |
3071 | The centra lized data repositor y supports the inter nal exchan ge of info rmation wi thin the V A research environme nt and com munication of data w ith stakeh olders in the resear ch communi ty. | |
3072 | Interopera bility | |
3073 | The RAMS s olution ut ilizes Jav a as the p rimary pla tform for User inter action in the View a nd Control ler compon ents of th e Java Mod el View Co ntroller ( MVC) desig n framewor k in Strut s2. The tr adeoff of choosing J ava develo pment vs. SharePoint developme nt include s more eas e of custo mization o f the User front-end , graphics , function ality, and easier in teroperabi lity betwe en backend systems. | |
3074 | 1.The syst em shall s upport all recognize d health s ystem stan dards | |
3075 | 2.Systems must be he terogeneou s and agno stic for o perating s ystems and code base s. | |
3076 | 3.Provide the abilit y to secur ely transf er large f iles (of 4 -8 gigabyt es) from a n external source to VA system s. | |
3077 | 4.Provide access to the system over a re mote acces s solution . | |
3078 | Manageabil ity | |
3079 | Provide Se rvice Desk /Incident and Proble m Manageme nt trackin g related to mainten ance event s of patie nt care sy stems with priority over non-p atient car e systems. | |
3080 | Provide da ta-related to mainte nance even ts, both r outine and exception al, includ ing key me tadata: | |
3081 | Predicted routine wo rk | |
3082 | Occurrence s where ma intenance is complet ed, includ ing restar t from dow n time | |
3083 | Identity o f the orga nization p erforming maintenanc e | |
3084 | User perfo rming main tenance (i f availabl e) | |
3085 | Identity o f the syst em | |
3086 | Date/time, physical location | |
3087 | Systems im pacted | |
3088 | Whether it affects p atient car e | |
3089 | Non-urgent or emerge nt | |
3090 | Provide au dit capabi lities for system ac cess and u sage with settings t hat are co nfigurable to suppor t internal and exter nal audits based on Federal an d VHA mand ates. | |
3091 | The system must comp ly with VA Directive 6300 Reco rds and In formation Management and with VHA Record s Control Schedule ( RCS) 10-1, in genera l and spec ifically w ith Electr onic Final Version o f Health R ecord: Des troy/Delet e 75 years after las t episode of patient care, or longer (if specified ). | |
3092 | Performanc e | |
3093 | The perfor mance spec ifications solution will execu te perform ance, capa city, and independen t testing of its pro duct, and as part of Software Quality As surance (S QA) analys is and tes ting. | |
3094 | The ORD ai ms to impr ove the ef ficiency a nd perform ance of th e national VA resear ch program by implem enting an enterprise -wide rese arch admin istrative management system ac cessible t o: | |
3095 | ORD Centra l Office. | |
3096 | Active fie ld researc h offices | |
3097 | The implem ented tool will supp ort the ma jor busine ss functio ns of the: | |
3098 | Local rese arch offic e | |
3099 | Management of the Re search and Developme nt (R& D) Committee and its su bcommittee s (Institu tional Rev iew Board [IRB]) | |
3100 | Institutio nal Animal Care and Use Commit tee (IACUC ) | |
3101 | Subcommitt ee on Rese arch Safet y (SRS), | |
3102 | local rese arch offic e reportin g to ORD | |
3103 | The tool w ill also p rovide a c ommon data base for t racking an d reportin g of admin istrative research p rogram dat a througho ut the VA. | |
3104 | Table 23: Performanc e | |
3105 | SLR Questi on | |
3106 | SLR Criter ia | |
3107 | How many U sers will be on the system hou rly? | |
3108 | 101-1000 e stimated | |
3109 | How many t ransaction s will eac h average User perfo rm each ho ur? | |
3110 | >10 estima ted | |
3111 | What are t he anticip ated peak User times during th e day? | |
3112 | Business d ay (highes t peak Use r times Mo n. through Fri. duri ng adminis trative ho urs) | |
3113 | What is th e anticipa ted peak t ransaction load (whe n do you t hink that there will be the mo st transac tions bein g performe d on the s ystem) dur ing the da y? | |
3114 | Business d ay (highes t peak Use r times Mo n through Fri during administr ative hour s) | |
3115 | How many n ew Users w ill be add ed in one year? | |
3116 | 101-1000 e stimated | |
3117 | How many m ore (if an y) transac tions will be added in one yea r? | |
3118 | >10 estima ted | |
3119 | What kind of informa tion will be stored? (Specify average of each kind per month ) | |
3120 | Small docu ments (exa mple PDF o r Word fil e) | |
3121 | Forms & Do cuments th at are for matted (ex ample form s or docum ents with images) | |
3122 | What kind of search capacity i s required ? | |
3123 | Medium (11 -1000 per hour) | |
3124 | estimated | |
3125 | What type of system( s) is/are required? | |
3126 | Web-based and manage d from cen tral servi ce and dat abase | |
3127 | Intranet ( All VA) | |
3128 | Is there a need for heavy appl ication re porting? I f yes, whe n? | |
3129 | End of day , End of m onth, End of quarter | |
3130 | Reliabilit y | |
3131 | The system must be r eliable an d enable U ser trust. The follo wing summa rizes requ irements f or the RAM S new func tionality reliabilit y specific ations by providing: | |
3132 | Stable and reliable performanc e | |
3133 | Availabili ty – the s ystem shal l be avail able 8 a.m . to 8 p.m ., EST, Mo n. through Fri. | |
3134 | Accurate d ata - The system sha ll return entries ex actly as t hey were p assed, wit h no modif ication | |
3135 | Defect rep air – It i s expected that all defects re lated to t he impleme ntation ge t resolved during in itial deve lopment an d subseque nt UAT tes ting | |
3136 | Display of all data that is av ailable in native or interface d systems, and inten ded to be available in the app lication | |
3137 | Accessible informati on related to the so urce of da ta | |
3138 | When the s ystem goes live in P roduction, the devel opment tea m will add ress defec ts of a cr itical nat ure that a re deemed “show stop pers.” Enh ancement r equests ma de after ‘ go-live’ w ill be log ged for co nsideratio n in a fut ure, coord inated rel ease. | |
3139 | ||
3140 | Table 24: Reliabilit y | |
3141 | SLR Questi on | |
3142 | SLR Criter ia | |
3143 | Descriptio n | |
3144 | How much t ime should the syste m be avail able (and how much d own time i s acceptab le due to incident [ unexpected ] outage)? | |
3145 | 99.9% (8.7 6 hours do wn time) | |
3146 | Intentiona lly left b lank. | |
3147 | When shoul d the syst em be avai lable (wha t will be the core o perating h ours of th e system)? | |
3148 | 8 a.m. to 8 p.m., ES T, Mon. th rough | |
3149 | Fri. | |
3150 | The system shall req uire no mo re than 24 hours of maintenanc e per mont h. Servici ng and mai ntenance i s expected to occur during nig hts and we ekends. | |
3151 | How soon s hould the system ful ly recover from an o utage? (In cludes Mea n Time to Restore [M TRS]) | |
3152 | Disaster R ecovery wi thin 72 ho urs | |
3153 | Intentiona lly left b lank. | |
3154 | How much d ata will b e restored when outa ge is reco vered? | |
3155 | 100% (cont inuous bac k-up) | |
3156 | Intentiona lly left b lank. | |
3157 | What time period sho uld be con sidered fo r maintena nce period s? | |
3158 | After hour s (these w ould be of f peak hou rs approve d by the O ffice of R esearch an d Developm ent) | |
3159 | Intentiona lly left b lank. | |
3160 | In what st andard tim e zone wil l the syst em operate ? | |
3161 | All time z ones | |
3162 | Intentiona lly left b lank. | |
3163 | ||
3164 | Security | |
3165 | The RAMS s ystem shal l remain b ehind the VA firewal l and subj ect to VA security i nitiatives and proto cols. RAMS will exch ange PII o r other da ta that wo uld be dee med sensit ive; there fore, ther e is a nee d for encr yption of the data t hat is exc hanged bet ween RAMS and extern al data ba ses. RAMS Sign-on sh all be in compliance with VA s ecurity an d privacy standards. | |
3166 | Supportabi lity | |
3167 | The follow ing table lists the priority l evels of t he systems that will interface with the VA systems . | |
3168 | Table 25: System Sup portabilit y | |
3169 | BN 7 | |
3170 | System wil l interfac e with VA systems | |
3171 | ||
3172 | Priority L evel | |
3173 | 7.2 | |
3174 | RAMS inter facing wit h CITI | |
3175 | Medium pri ority | |
3176 | 7.3 | |
3177 | RAMS incor porating t he functio nality of WinRMS | |
3178 | Medium pri ority | |
3179 | 7.4 | |
3180 | RAMS incor porating t he functio nality of eJIT | |
3181 | Medium pri ority | |
3182 | 7.5 | |
3183 | RAMS inter facing wit h TMS | |
3184 | Medium pri ority | |
3185 | 7.6 | |
3186 | RAMS incor porating t he functio nality of RAFT | |
3187 | Medium pri ority | |
3188 | Provide al erts (that extend be yond syste m messages to extern al systems , like mob ile device s) for mal functions, while pre venting fa lse alarms for local , regional , and nati onal evalu ations in real time. | |
3189 | Provide re ports on p erformance metrics, as specifi ed in the RAMS Effec tiveness a nd Value / Benefits Framework, on a bi-w eekly basi s. | |
3190 | Provide na tional, re gional, an d local re ports on p erformance metrics, as specifi ed in the RAMS Effec tiveness a nd Value / Benefits Framework. | |
3191 | Provide pe rformance metrics (f rom reques t for info rmation to receipt o f informat ion on the screen) m onitored b y the syst em and sys tem admini strators s o they kno w what the User expe rience is like witho ut Users h aving to c all them a nd tell th em the sys tem is run ning very slow. | |
3192 | Provide th e ability for VHA an d IT staff to create standard and ad-hoc reports o f usage, b andwidth, response t ime, login time, and other var iables wit h a verifi cation pro cess for m easuring t he capabil ities of t he system. | |
3193 | Provide en d-User tra ining on h ow to gene rate the v arious sys tem perfor mance repo rts (e.g., in standa rd file fo rmats, suc h as Comma Separated Values [C SV], Porta ble Docume nt Format [PDF], or Excel) dep ending on the User's needs. | |
3194 | Provide th e ability to view sy stem stati stics (e.g ., informa tion on th e specific network e nvironment ) and iden tify areas that are having iss ues, or ar e beyond c apacity, i n near-rea l-time (to be quanti fied at a later time ). | |
3195 | Technical Help Desk support fo r the appl ication vi a instant message, o n-line, ph one, and r emote desk top access support, shall be p rovided fo r Users to obtain as sistance 2 4/7. | |
3196 | The IT sol ution shal l be desig ned to com ply with t he applica ble approv ed Enterpr ise SLAs. | |
3197 | Data prote ction meas ures, such as back-u p interval s and redu ndancy, sh all be con sistent wi th systems categoriz ed as miss ion critic al (1hr re storation, 2hrs back up recover y). Impact of system failure m ust be mon itored on a near-rea l-time bas is. | |
3198 | Provide th e ability to set thr esholds an d notifica tion type (e.g., ema il or text alerts) w hen alerti ng the Use r about re sponse tim e degradat ion and un scheduled outages. | |
3199 | Disaster R ecovery Pl ans (DRP) and Contin uity of Op erations P lan (COOP) will be u pdated and tested se mi-annuall y to addre ss the RAM S applicat ion (see N ational Se curity and Homeland Security P residentia l Directiv e: Nationa l Continui ty Policy. NSPD-51/H SPD-20, Ma y 9, 2007) | |
3200 | Usability | |
3201 | User Exper ience enco mpasses di rect and i ndirect in teractions between t he User an d the syst em. Improv ing usabil ity over t he prior v ersion is a key requ irement fo r this app lication. The Intern ational Or ganization for Stand ardization (ISO) def ines usabi lity as “t he extent to which a product c an be used by specif ied users to achieve specified goals wit h effectiv eness, eff iciency, a nd satisfa ction in a specified context o f use” (19 98). | |
3202 | For an opt imal User experience , the syst em must me et the req uirements outlined i n this sec tion, whic h involve attributes of the ap plication and the pr ocess requ ired to ac hieve them . | |
3203 | In order t o improve usability of VA-deve loped or p urchased a pplication s, the fol lowing act ions are r equired: | |
3204 | In accorda nce with t he Office of the Nat ional Coor dinator fo r Health I nformation Technolog y’s Meanin gful Use S tage 2 fin al ruling, employ an industry- recognized User-Cent ered Desig n (UCD) pr ocess. The methods f or UCD are well defi ned in doc uments and requireme nts, such as ISO 924 1–11, ISO 13407, ISO 16982, Na tional Ins titute of Standards and Techno logy Inter agency Rep ort 7741, ISO/Intern ational El ectrochemi cal Commis sion 62366 , and ISO 9241-210. Developers will choo se their U CD approac h; one or more speci fic UCD pr ocesses wi ll not be prescribed . | |
3205 | Adhere to an industr y-recogniz ed User In terface (U I) Best Pr actices Gu ideline or Style Gui de. For ex ample, fir st follow UI guideli nes for th e developm ent platfo rm. In ins tances whe re platfor m guidelin es are not available , adhere t o the VA B est Practi ces Guidel ines/Style Guide. | |
3206 | Inform req uirements and design s with det ailed huma n factors work produ cts that h ave been/w ill be com pleted for the speci fic projec t. Example s of speci fic human factors ac tivities m ight inclu de heurist ic evaluat ions, site visits, i nterviews, applicati on-specifi c design g uides, and usability testing o n existing systems o r prototyp es. | |
3207 | A sound UC D and deve lopment pr ocess base d on human factors s hould incl ude the fo llowing ac tivities: | |
3208 | Understand ing of the Users, th e Users’ t asks, and the Users’ environme nts | |
3209 | Review of similar or competiti ve systems to inform requireme nts and de sign | |
3210 | Heuristic evaluation of prior versions, prototypes , or basel ine applic ations, if applicabl e | |
3211 | Iterative design and formative usability testing ( formative usability testing is used to d iscover us ability pr oblems dur ing the de sign and d evelopment process) | |
3212 | User risk analysis | |
3213 | Summative validation usability testing ( summative usability testing is used to q uantify an d validate usability of a prod uct with m easures of effective ness, effi ciency, Us er percept ions, etc. ) | |
3214 | To demonst rate high usability, the appli cation sho uld be: | |
3215 | Intuitive and easy t o learn, w ith minima l training ; | |
3216 | Effective by allowin g Users to successfu lly comple te tasks; | |
3217 | Efficient by allowin g Users to complete their work in a mann er consist ent with c linical pr actice and workflow; | |
3218 | Perceived to have hi gh usabili ty, as dem onstrated by appropr iate surve y measures ; and | |
3219 | Designed t o aid User s in meeti ng task go als withou t being an additiona l burden. | |
3220 | The system must be r eliable an d enable U ser trust by providi ng: | |
3221 | Stable and reliable performanc e; | |
3222 | Accurate d ata; | |
3223 | Display of all data that is av ailable in native or interface d systems and intend ed to be a vailable i n the appl ication; a nd | |
3224 | Accessible informati on related to the so urce of da ta. | |
3225 | The applic ation shou ld include a modern Graphical User Inter face that allows the User to v iew data f rom multip le sources and inclu des: | |
3226 | Integrated display o f structur ed and uns tructured data; | |
3227 | Rich data visualizat ion and gr aphical di splay of d ata; | |
3228 | Ability to switch be tween tabu lar and gr aphical da ta views; | |
3229 | Ability to interact with displ ayed data to obtain additional details r elated to the data a nd source of the dat a; and | |
3230 | User custo mizable co mponents a nd setting s. | |
3231 | The applic ation must provide f or advance d and up-t o-date sea rching, to include: | |
3232 | Fast searc h function ality with auto-comp lete and r eal-time d isplay of matched re sults duri ng typing; and | |
3233 | Search his tory. | |
3234 | The applic ation must provide f or advance d filterin g capabili ties, to i nclude: | |
3235 | Filtering of data ta bles, list s, and gri ds; and | |
3236 | Filtering of search results. | |
3237 | The applic ation desi gn should be modifie d to: | |
3238 | Address th e specific findings from a hum an factor heuristic evaluation conducted on the pr ior versio n of the a pplication ; | |
3239 | Address th e specific findings reported f rom field use of the prior ver sion; and | |
3240 | Address th e specific findings reported f rom usabil ity testin g of the p rior versi on or rele vant proto types. | |
3241 | ||
3242 | Documentat ion | |
3243 | The follow ing refere nces BN4 o n the docu mentation criteria o f the RAMS training curriculum : | |
3244 | Manage dat a about pe rsonnel en gaged in r esearch at VAMC faci lities | |
3245 | Automate t he trackin g of train ing, scope of practi ce, and al l necessar y certific ations for PIs and o ther emplo yees | |
3246 | Notify PI or PI Desi gnee and e mployee wh en trainin g is requi red includ ing annual /biannual re-trainin g | |
3247 | ||
3248 | Appendix B : Acronyms | |
3249 | The follow ing is a l ist of acr onym defin itions: | |
3250 | Table 26: Acronyms | |
3251 | Term | |
3252 | Definition | |
3253 | ACORP | |
3254 | Animal Com ponent of Research P rotocol | |
3255 | ACOS | |
3256 | Associate Chief of S taff | |
3257 | AFM | |
3258 | Animal Fac ility Mana ger | |
3259 | AO | |
3260 | Administra tive Offic er | |
3261 | BN | |
3262 | Business N eed | |
3263 | BRD | |
3264 | Business R equirement s Document | |
3265 | CITI | |
3266 | Collaborat ive Instit utional Tr aining Tal ent Manage ment Syste m (TMS) | |
3267 | COI | |
3268 | Conflict o f Interest | |
3269 | CR | |
3270 | Continuing Review | |
3271 | CSP | |
3272 | Cooperativ e Studies Program | |
3273 | FY | |
3274 | Fiscal Yea r | |
3275 | IACUC | |
3276 | Institutio nal Animal Care and Use Commit tee | |
3277 | IPA | |
3278 | In-Person Authentica tion (IPA) | |
3279 | IRB | |
3280 | Institutio nal Review Board | |
3281 | LASIF | |
3282 | Large Scal e Seismic Inversion Framework | |
3283 | LSA | |
3284 | Local Syst em Adminis trator | |
3285 | LSI | |
3286 | Local Site Investiga tor | |
3287 | MOU | |
3288 | Memorandum of Unders tanding | |
3289 | MS | |
3290 | Microsoft | |
3291 | NDO | |
3292 | Normalized Data Obje ct | |
3293 | NSR | |
3294 | New Servic e Request | |
3295 | ORO | |
3296 | Office of Research O versight | |
3297 | PI | |
3298 | Principal Investigat or | |
3299 | R&D | |
3300 | Research a nd Develop ment | |
3301 | RAMS | |
3302 | Research A dministrat ive Manage ment Syste m | |
3303 | RCO | |
3304 | Research C ompliance Officer | |
3305 | RDIS | |
3306 | Research a nd Develop ment Infor mation Sys tem | |
3307 | RDM | |
3308 | Requiremen ts Develop ment and M anagement | |
3309 | RED | |
3310 | Requiremen ts Elabora tion Docum ent | |
3311 | RPSS | |
3312 | Research P rotocol Sa fety Surve y | |
3313 | RSD | |
3314 | Requiremen ts Specifi cation Doc ument | |
3315 | SAE | |
3316 | Serious Ad verse Even t | |
3317 | SDD | |
3318 | Software D esign Docu ment | |
3319 | SOP | |
3320 | Standard O perating P rocedure | |
3321 | SRS | |
3322 | Subcommitt ee on Rese arch Safet y | |
3323 | SSA | |
3324 | System Sit e Administ rator | |
3325 | TMS | |
3326 | Talent Man agement Sy stem | |
3327 | UAP | |
3328 | Unanticipa ted Proble m Report | |
3329 | VA | |
3330 | Department of Vetera ns Affairs | |
3331 | VAMC | |
3332 | Department of Vetera ns Affairs Medical C enter | |
3333 | VMU | |
3334 | Veterinary Medical U nit | |
3335 | WOC | |
3336 | Without Co mpensation | |
3337 | XML | |
3338 | Extensible Markup La nguage | |
3339 | In additio n to the a bove refer enced acro nym table, please re fer to the RAMS Libr ary for ad ditional V A acronym informatio n. | |
3340 | ||
3341 | ||
3342 | Template R evision Hi story | |
3343 | Date | |
3344 | Version | |
3345 | Descriptio n | |
3346 | Author | |
3347 | September 2015 | |
3348 | 1.7 | |
3349 | Updated He adings and spacing t o conform with lates t OIT Docu mentation Standards guidelines | |
3350 | Process Ma nagement | |
3351 | June 2015 | |
3352 | 1.6 | |
3353 | Updated to conform w ith latest Section 5 08 guideli nes and re mediated w ith Common Look Offi ce tool | |
3354 | Process Ma nagement | |
3355 | May 2015 | |
3356 | 1.5 | |
3357 | Revised by the PMAS Process Im provement Lockdown T eam | |
3358 | PMAS Proce ss Improve ment Lockd own Team | |
3359 | December 2 014 | |
3360 | 1.4 | |
3361 | Updated to conform w ith latest Section 5 08 guideli nes and re mediated w ith Common Look Offi ce tool | |
3362 | Process Ma nagement | |
3363 | May 2014 | |
3364 | 1.3 | |
3365 | Reordered cover page to enhanc e search c apabilitie s | |
3366 | Process Ma nagement | |
3367 | May 2013 | |
3368 | 1.2 | |
3369 | Add Append ix for acr onyms and glossary | |
3370 | Process Ma nagement | |
3371 | March 2013 | |
3372 | 1.1 | |
3373 | Formatted to current ProPath d ocumentati on standar ds and edi ted to con form with latest Alt ernative T ext (Secti on 508) gu idelines | |
3374 | Process Ma nagement | |
3375 | January 20 13 | |
3376 | 1.0 | |
3377 | Initial Ve rsion | |
3378 | PMAS Busin ess Office |
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