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1 | RAMS.zip\RAMS\Docs | RAMS_Integration_Requirements_Specification_Document_Revised_1.5.doc | Wed Oct 18 12:53:06 2017 UTC |
2 | RAMS.zip\RAMS\Docs | RAMS_Integration_Requirements_Specification_Document_Revised_1.5.doc | Wed Oct 18 13:01:42 2017 UTC |
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1 | Requiremen ts Specifi cation Doc ument Temp lateResear ch Adminis trative Ma nagement S ystem (RAM S) Integra tion | |
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 | DateVersio nDescripti onAuthor1/ 3/20161.5R eview for 2001 submi ssion10/03 /20161.4Fi nal Versio n of RSD f or RAMS In tegrationB ylight08/1 5/161.32.6 Functiona l Requirem ents: Adde d R&D, Saf ety, and I ACUC | |
10 | 2.4 Disast er Recover y Specific ation | |
11 | 2.3. | |
12 | Design Con straints S pecificati on - Depen dencies an d Constrai nts- Addit ional Iden tified Des ign Constr aints: | |
13 | 2.3. | |
14 | Design Con straints S pecificati on - Depen dencies an d Constrai nts- Const raints - N ot a requi rement for RAMS Inte gration | |
15 | 2.2. | |
16 | Business R ules Speci fication: Added corr esponding requiremen t to each Business R uleAnnie M . Lee7-01- 20161.2Sco pe clarifi cation as per PWSByL ight6-15-2 0161.1Scop e revised to PWSByLi ght2-05-20 161.0Updat ed Final V ersion Sen t for Appr ovalEngili ty1-18-201 60.2Final Version Se nt for App roval – Re turned for UpdatesEn gility12-2 3-20150.1I nitial Ver sionEngili tyArtifact Rationale | |
17 | 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. | |
18 | 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. | |
19 | Instructio ns | |
20 | ActivityNe w Capabili ty (1)Feat ure Enhanc ement (2)F ield Deplo yment (A)N oNoCloud/W eb Deploym ent (B)Yes YesMobile Applicatio n (C)NoNoT able of Co ntents | |
21 | 1. | |
22 | Introducti on | |
23 | 1 | |
24 | 1.1. | |
25 | Purpose | |
26 | 5 | |
27 | 1.2. | |
28 | Scope | |
29 | 5 | |
30 | 1.3. | |
31 | References | |
32 | 6 | |
33 | 2. | |
34 | Overall De scription | |
35 | 7 | |
36 | 2.1. | |
37 | Accessibil ity Specif ications | |
38 | 7 | |
39 | 2.2. | |
40 | Business R ules Speci fication | |
41 | 7 | |
42 | 2.3. | |
43 | Design Con straints S pecificati on | |
44 | 9 | |
45 | 2.4. | |
46 | Disaster R ecovery Sp ecificatio n | |
47 | 11 | |
48 | 2.5. | |
49 | Documentat ion Specif ications | |
50 | 11 | |
51 | 2.6. | |
52 | Functional Specifica tions | |
53 | 12 | |
54 | 2.7. | |
55 | Graphical User Inter face (GUI) Specifica tions | |
56 | 49 | |
57 | 2.8. | |
58 | Multi-Divi sional Spe cification s | |
59 | 49 | |
60 | 2.9. | |
61 | Performanc e Specific ations | |
62 | 49 | |
63 | 2.10. | |
64 | Quality At tributes S pecificati on | |
65 | 51 | |
66 | 2.11. | |
67 | Reliabilit y Specific ations | |
68 | 51 | |
69 | 2.12. | |
70 | Scope Inte gration | |
71 | 53 | |
72 | 2.13. | |
73 | Security S pecificati ons | |
74 | 53 | |
75 | 2.14. | |
76 | System Fea tures | |
77 | 77 | |
78 | 2.15. | |
79 | Usability Specificat ions | |
80 | 77 | |
81 | 3. | |
82 | Purchased Components | |
83 | 83 | |
84 | 4. | |
85 | Estimation | |
86 | 83 | |
87 | 5. | |
88 | Approval S ignatures | |
89 | 85 | |
90 | Appendix A : Non-Func tional Req uirements | |
91 | 86 | |
92 | Appendix B : Acronyms | |
93 | 101 | |
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. | |
114 | Manage the activitie s of the R &D Committ ee, which includes t he followi ng: | |
115 | Adding use rs and set ting permi ssions | |
116 | Adding mem bers to co mmittees a nd trackin g appointm ent dates | |
117 | Allow the R&D Commit tee to com plete requ ired repor ts and for ms online | |
118 | Allow the R&D Commit tee to sch edule meet ings, noti fy members and colle ct feedbac k from oth er subcomm ittees | |
119 | Allow the R&D Commit tee to pub lish and s tore meeti ng minutes | |
120 | Ensure com pliance wi th federal and VA re gulations | |
121 | 2. | |
122 | Provide co mmunicatio ns portals among the R&D Commi ttee and s ubcommitte e | |
123 | 3. | |
124 | Provide ea sily acces sible repo rting capa bility at the local headquarte rs levels | |
125 | 4. | |
126 | Enable the ORD Centr al Office to create reports co vering ent erprise wi de researc h activiti es. | |
127 | The Instit utional An imal Care and Use Co mmittee (I ACUC) | |
128 | 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. | |
129 | 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. | |
130 | The IACUC is respons ible for t he followi ng: | |
131 | Semi-Annua l Program and Facili ty Self-As sessment R eviews | |
132 | 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. | |
133 | Research P roposal Re views | |
134 | 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. | |
135 | IACUC Semi -Annual Se lf-Assessm ent Review s | |
136 | 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. | |
137 | Annual VA Veterinary Medical U nit (VMU) Report | |
138 | 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. | |
139 | 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. | |
140 | The Subcom mittee on Research S afety (SRS ) | |
141 | 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. | |
142 | 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: | |
143 | Facility D irectors | |
144 | ACOS | |
145 | R&D Commit tee | |
146 | Principle Investigat or (PI) or PI Design ee | |
147 | The SRS is responsib le for the following : | |
148 | 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. | |
149 | 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. | |
150 | 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. | |
151 | 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 . | |
152 | 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: | |
153 | 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 | |
154 | Reporting follow-up results to the R&D C ommittee. | |
155 | 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. | |
156 | 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. | |
157 | Maintainin g adequate documenta tion of al l the SRS or equival ent subcom mittee act ivities. | |
158 | Forwarding minutes o f SRS to t he Researc h Office. | |
159 | Ensuring t hat all la boratory p ersonnel r eceive ann ual resear ch specifi c safety t raining. | |
160 | Holding SR S meetings at least quarterly. | |
161 | 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. | |
162 | 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 . | |
163 | Evaluating annually the effect iveness of the labor atory’s Ch emical Hyg iene Plan and making necessary revisions . | |
164 | 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. | |
165 | Ensuring t he proper reporting of injury and illnes s trends t o the R&D Committee, as approp riate. | |
166 | 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. | |
167 | 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). | |
168 | 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. | |
169 | Providing technical assistance , where ap propriate, in recycl ing progra ms and red uction of the quanti ty of wast e. | |
170 | 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 ). | |
171 | Purpose | |
172 | 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 . | |
173 | 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). | |
174 | 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. | |
175 | Scope | |
176 | 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. | |
177 | 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. | |
178 | 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 . | |
179 | The RAMS I ntegration will serv e as a mul tipurpose tool for t he Veteran s Affairs Central Of fice ( DNS ) ORD and VAMC field research offices. W ith the RA MS Integra tion, thes e offices will be ab le to: | |
180 | create and track adm inistrativ e data for individua l projects that are active or pending at local res earch site s; | |
181 | manage res earch over sight comm ittees and sub-commi ttees; | |
182 | track rese arch perso nnel assig nments, tr aining req uirements, and certi fications; | |
183 | manage lab oratory sp ace and eq uipment in ventory, i ncluding s pace alloc ations and equipment ; and | |
184 | support re quired rep orting to ORD. | |
185 | References | |
186 | The follow ing docume nts were r eferenced in the dev elopment o f this Req uirements Specificat ion Docume nt (RSD): | |
187 | RAMS Integ ration BRD 5-1-15 | |
188 | RAMS Elabo rated Requ irements D ocument 05 OCT15 | |
189 | 1200 VHA R esearch Pr ogram | |
190 | VHA Handbo ok 1200.01 Research and Develo pment Comm ittee | |
191 | VHA Handbo ok 1200.05 Human Sub jects | |
192 | VHA Handbo ok 1200.07 Animal Re search | |
193 | VHA Handbo ok 1200.08 Safety | |
194 | Additional reference s: | |
195 | ProPath We bsite | |
196 | Project Ma nagement A ccountabil ity System (PMAS) Pr ogram Mana gement Doc ument Repo sitory | |
197 | Section 50 8 Requirem ents | |
198 | Technical Reference Model (TRM ) | |
199 | Department of Vetera ns Affairs Handbook 6500 | |
200 | VA Directi ve 6500 – Informatio n Security Program | |
201 | Office of Informatio n and Tech nology (OI &T) Techni cal Servic es Project Repositor y (TSPR) W ebsite | |
202 | NARA – Nat ional Arch ives Recor ds Associa tion Polic y | |
203 | RCS – Reco rds Contro l Schedule | |
204 | Overall De scription | |
205 | 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). | |
206 | The non-fu nctional r equirement s are addr essed in A ppendix A. | |
207 | Accessibil ity Specif ications | |
208 | 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. | |
209 | Table 1: A ccessibili ty Specifi cations | |
210 | Req. IDReq uirementIn crement | |
211 | (1, 2, Fut ure)ACC-00 1The RAMS Integratio n shall co mply with Section 50 8 requirem ents. 1,2 | |
212 | (VA Direct ive)ACC-00 2The RAMS Integratio n system s hall compl y with Acc essibility Guideline s 1,2 | |
213 | (VA Direct ive)Busine ss Rules S pecificati on | |
214 | 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: | |
215 | 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. | |
216 | 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) | |
217 | 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) | |
218 | 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) | |
219 | 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.) | |
220 | 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.) | |
221 | 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. ) | |
222 | 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.) | |
223 | 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 .) | |
224 | 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) | |
225 | 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) | |
226 | 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 ) | |
227 | 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) | |
228 | 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) | |
229 | 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) | |
230 | 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) | |
231 | 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) | |
232 | 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) | |
233 | 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) | |
234 | 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) | |
235 | 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 ) | |
236 | 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) | |
237 | 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. | |
238 | Design Con straints S pecificati on | |
239 | 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). | |
240 | 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. | |
241 | 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. | |
242 | 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. | |
243 | Memory Con straints a nd Databas e Requirem ents | |
244 | 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 . | |
245 | Dependenci es and Con straints | |
246 | Successful implement ation of t his projec t requires adequate training a nd educati on for end Users and support s taff. | |
247 | All new fu nctionalit y to the a pplication /system is subject t o funds av ailability . | |
248 | Constraint s | |
249 | 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. | |
250 | Additional Identifie d Design C onstraints : | |
251 | The system shall com ply with a ll VA Ente rprise Arc hitecture Standards | |
252 | 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.” | |
253 | 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. | |
254 | Services s hall be bu ilt using standards that promo te interop erability. [5] | |
255 | 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. | |
256 | Services i mplementat ion shall be loosely coupled t o the serv ice interf ace. | |
257 | A service interface is the sol e entry po int into s ervice log ic and res ources. | |
258 | Services s hall be ac cessed onl y via the exposed, p ublished i nterfaces. | |
259 | 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. | |
260 | 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 . | |
261 | No service shall use static (e .g., hard- coded) ser vice addre sses. | |
262 | Service lo gic expose d by the s ervice sha ll handle concurrent access wi thout dead lock or lo ss of data integrity . | |
263 | 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 . | |
264 | 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. | |
265 | 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. | |
266 | The follow ing table lists the technology that will be utiliz ed with th e RAMS Int egration. | |
267 | Table 2: L ist of Tec hnologies | |
268 | Technology NameMicro soft Struc tured Quer y Language (SQL) Ser ver 2012 M icrosoft S QL Server Reporting Services 2 012Microso ft SharePo int 2013 S P1Microsof t Windows Server 200 8 R2/2012 Red Hat En terprise L inux 7.0.5 7SQL Serve r Integrat ion Servic es 2012 | |
269 | The open- source sof tware appl ication th at is util ized is: | |
270 | Apache Tom cat 7.x (L atest Stab le) | |
271 | The Softwa re Develop ment frame work and p latform ut ilized is: | |
272 | Java Enter prise Edit ion 7 | |
273 | 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: | |
274 | Rational T ool Set | |
275 | Microsoft (MS) Visua l Studio 2 010 | |
276 | The standa rds that a pply to th is design document, at a minim um, includ e: | |
277 | VA Handboo k 6500.3 C ertificati on & Accre ditation | |
278 | VA Handboo k 6102 Int ernet/Intr anet Servi ces | |
279 | Disaster R ecovery Sp ecificatio n | |
280 | 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 : | |
281 | The system should be fully res tored with in seventy -two (72) hours of a n outage. | |
282 | After an o utage, 99% of the da ta will ne ed to be r estored. | |
283 | 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. | |
284 | Documentat ion Specif ications | |
285 | 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. | |
286 | Documentat ion will p otentially include, but is not limited t o, the fol lowing: | |
287 | Standard O perating P rocedures | |
288 | Change Man agement Pr ocess | |
289 | User manua l for soft ware: | |
290 | 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. | |
291 | Technical documentat ion | |
292 | Maintenanc e agreemen ts/documen tation: | |
293 | 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. | |
294 | Implementa tion Guide | |
295 | A technica l training curriculu m shall be developed and deliv ered to al l levels o f staff Us ers: | |
296 | 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. | |
297 | 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 . | |
298 | The traini ng curricu lum shall state the expected t ask comple tion time for primar y and seco ndary User s. | |
299 | Technical Help Desk support fo r the appl ication sh all be pro vided to U sers. | |
300 | Functional Specifica tions | |
301 | 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. | |
302 | 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. | |
303 | 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. | |
304 | Table 3: E pic BN1 | |
305 | 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. IDPriority As a… I wa nt…So that …Acceptanc e Criteria /User Stor y NotesBN1 HighRAMS U serTo be a ble to que ry the dat abase usin g standard ized termi nology (fo r data ele ments).I h ave the ab ility to s uccessfull y query th e database using sta ndardized technology .To be abl e to query the datab ase using standardiz ed technol ogy.The ta ble below lists the Epic and d etailed Us er Narrati ves (Busin ess Requir ements) fo r BN2/Elab oration Bu siness Req uirement 5 . | |
306 | Table 4: E pic BN2 | |
307 | 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.IDPrio rityAs a… I want…So that…Accep tance Crit eria/User Story Note sBN2.1.2Hi ghPrincipa l Investig ator (PI) or PI Desi gneeTo ent er, edit, and attach documents to IACUC projects i n database .I have th e ability to initiat e an IACUC applicati on for a n ew study. This inclu des enteri ng all dat a (pertine nt and imp ertinent) in the RAM S database . | |
308 | 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. T o be able to enter, edit, and attach doc uments to IACUC proj ects in da tabase. | |
309 | 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 .BN2.2.2Hi ghLocal Sy stem Admin istrator ( LSA) | |
310 | and | |
311 | Administra tive Offic er (AO)To add Users and set pe rmissions for IACUC, R&D, Safe ty, and Re search Com pliance Of ficer (RCO ). | |
312 | And | |
313 | Add Users and set pe rmissions for IACUC, R&D, Safe ty, and RC OI have th e ability to add IAC UC Users t o the syst em. | |
314 | I have the ability t o assign I ACUC Users access pe rmissions. | |
315 | I have the ability t o add R&D Users to t he system. | |
316 | I have the ability t o add R&D Users acce ss permiss ions. | |
317 | I have the ability t o add Safe ty Users t o the syst em. | |
318 | I have the ability t o assign S afety User s access p ermissions . | |
319 | I have the ability t o add RCO Users to t he system. | |
320 | I have the ability t o assign R CO Users a ccess perm issions. | |
321 | I have the ability t o ensure t hat access to studie s is restr icted to a uthorized Users. | |
322 | I have the ability t o ensure t hat access to IACUC data is re stricted t o authoriz ed Users.T o be able to add Use rs and set permissio ns for IAC UC, R&D, S afety, and RCO. | |
323 | NOTE: Unau thorized U sers are n ot permitt ed to acce ss or edit study dat a. | |
324 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.2.3Hig hRAMS User | |
325 | and | |
326 | Administra tive Offic erTo print complete applicatio n with all sections in one doc ument R&D, Safety, a nd IACUC c ommittees. I have the ability t o search f or key wor ds in the R&D commit tee. | |
327 | 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. | |
328 | I have the ability t o search f or key wor ds in the Safety com mittee. | |
329 | 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. | |
330 | I have the ability t o search f or key wor ds in the IACUC comm ittee. | |
331 | I have the ability t o search i n order to identify studies pe rtaining t o specific topics in the IACUC committee . | |
332 | To be able to print complete a pplication with all sections i n one docu ment. | |
333 | 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. | |
334 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.2.4Hig hAdministr ative Offi cer | |
335 | and | |
336 | Principal Investigat or or PI D esigneeTo manage inv estigators and perso nnel relat ed to rese arch proje cts in the R&D, Safe ty, and IA CUC commit tees.I hav e the abil ity to man age invest igators an d personne l related to researc h projects in the R& D committe e. | |
337 | 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. | |
338 | 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.T o be able to manage investigat ors and pe rsonnel re lated to r esearch pr ojects. | |
339 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.2.4.2H ighAdminis trative Of ficer | |
340 | and | |
341 | Principal Investigat or or PI D esigneeTo manage inv estigators and perso nnel relat ed to R&D, Safety, a nd IACUC r esearch pr ojects.I h ave the ab ility to t rack which personnel are assig ned to spe cific stud ies in the R&D commi ttees. | |
342 | 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. | |
343 | I have the ability t o track wh ich person nel are as signed to specific s tudies in the Safety committee s. | |
344 | 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 . | |
345 | I have the ability t o track wh ich person nel are as signed to specific s tudies in the IACUC committees . | |
346 | 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..To be able t o manage i nvestigato rs and per sonnel rel ated to IA CUC resear ch project s. | |
347 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.2.5Hig hPrincipal Investiga tor or PI DesigneeTo support a uto fill r eports and forms req uired by R &D, Safety , IACUC an d subcommi ttees.I ha ve the abi lity to co mplete var ious forms required for an IRB applicati on. | |
348 | 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. | |
349 | I have the ability t o complete various f orms requi red for an R&D appli cation. | |
350 | 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. | |
351 | I have the ability t o complete various f orms requi red for an Safety ap plication. | |
352 | 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. | |
353 | I have the ability t o complete various f orms requi red for an IACUC app lication. | |
354 | 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 . | |
355 | Support au tofill rep orts and f orms requi red by R&D and subco mmittees. | |
356 | Note: Syst em calcula tes which forms are required a nd provide s links to complete form onlin e. | |
357 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.2.6Hig hPrincipal Investiga tor or PI DesigneeTo attach re view commi ttee forms , includin g data sec urity, Con flict of I nterest (C OI), safet y, radiati on and IRB , R&D, Saf ety, or IA CUC forms to project . Tag uplo aded forms by type, date, and author.I h ave the ab ility to d igitally a ttach revi ew committ ee forms t o an IRB s tudy appli cation. | |
358 | I have the ability t o tag uplo aded IRB r eview comm ittee form s by type. | |
359 | I have the ability t o upload r eview IRB committee forms by d ate. | |
360 | I have the ability t o upload r eview IRB committee forms by a uthor. | |
361 | I have the ability t o digitall y attach r eview comm ittee form s to a R&D study app lication. | |
362 | I have the ability t o tag uplo aded R&D r eview comm ittee form s by type. | |
363 | I have the ability t o upload r eview R&D committee forms by d ate. | |
364 | I have the ability t o upload r eview R&D committee forms by a uthor. | |
365 | I have the ability t o digitall y attach r eview comm ittee form s to a Saf ety study applicatio n. | |
366 | 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. | |
367 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to tag uploaded r eview Safe ty committ ee forms b y type. | |
368 | I have the ability t o upload | |
369 | review Saf ety commit tee forms by date. | |
370 | I have the ability t o upload r eview Safe ty committ ee forms b y author. | |
371 | I have the ability t o | |
372 | digitally attach rev iew | |
373 | committee forms to a n IACUC s tudy appli cation. | |
374 | I have the ability t o tag uplo aded revie w IACUC | |
375 | committee forms by t ype. | |
376 | I have the ability t o upload | |
377 | review IAC UC committ ee forms b y date. | |
378 | I have the ability t o upload r eview IAC UC committ ee formsby author.2. 7MediumPri ncipal Inv estigator or PI Desi gneeTo sub mit and tr ack eligib ility and off-site w aivers in the IRB, R &D, Safety , and IACU C committe es.I have the abilit y to submi t a reques t for an o ff-site wa iver in th e IRB comm ittee appl ication. | |
379 | 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. | |
380 | 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. | |
381 | I have the ability t o submit a request f or an off- site waive r in the R &D applic ation. com mittee | |
382 | 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. | |
383 | 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. | |
384 | I have the ability t o submit a request f or an off- site waive r in the S afety comm ittee appl ication. | |
385 | . | |
386 | To be able to submit and track eligibili ty and off -site waiv ers. | |
387 | 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) | |
388 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to unde rstand the rules | |
389 | for an off -site waiv er in the Safety com mittee app lication. | |
390 | I have the ability t o | |
391 | receive a ruling aft er a | |
392 | request ha s been mad e | |
393 | for the wa iver in th e Safety c ommittee a pplication . | |
394 | I have the ability t o submit a request f or an off- site | |
395 | waiver in the IACUC committee applicatio n. | |
396 | I have the ability t o u for an off-site waiver in the IACUC committee applicatio n. . | |
397 | I have the ability t o understa nd the rul es | |
398 | receive a ruling aft er a reque st has bee n made for the waive r in the I ACUC commi ttee appli cation.2.9 HighAdmini strative O fficer | |
399 | and | |
400 | Associate Chief of S taff for R esearchTo track spon sorship an d funding status for projects in the R&D , Safety, and IACUC committees .I have th e ability to track t he sponsor ship for e ach projec t in the R &D committ ees. | |
401 | I have the ability t o track cu rrent fund ing status for each project in the R&D c ommittees. | |
402 | 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 R&D commi ttees. | |
403 | I have the ability t o track th e sponsors hip for ea ch project in the Sa fety commi ttees. | |
404 | I have the ability t o track cu rrent fund ing status for each project in the Safet y committe es. | |
405 | 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. | |
406 | I have the ability t o track th e sponsors hip for ea ch | |
407 | To be able to track sponsorshi p and fund ing status for proje cts. | |
408 | ||
409 | Note: AO c an select Funding St atus Repor t and view funding s tatus for each proje ct by spon sor. | |
410 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.projec t in the I ACUC commi ttees. | |
411 | I have the ability t o track cu rrent fund ing status for each project in the IACUC committee s. | |
412 | 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.2. 10.2HighPr incipal In vestigator or PI Des igneeTo su bmit all R &D, Safety , and IACU C progress reports a nd reviews .I have th e ability to submit an annual report ele ctronicall y for R&D committees . | |
413 | When neede d, I have the abilit y to submi t a tri-an nual revie w for R&D committees . | |
414 | When neede d, I have the abilit y to submi t an ad-ho c review f or R&D com mittees. | |
415 | I have the ability t o be notif ied when a n annual r eport is d ue for R&D committee s. | |
416 | 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. | |
417 | I have the ability t o submit a n annual r eport elec tronically for Safet y committe es. | |
418 | When neede d, I have the abilit y to submi t a tri-an nual revie w for Safe ty committ ees. | |
419 | To be able to submit Annual or Final (or as needed ) R&D, Saf ety, and I ACUC Proje ct Reports . | |
420 | 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. | |
421 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.When n eeded, I h ave the ab ility to s ubmit an a d-hoc revi ew for the Safety co mmittees. | |
422 | I have the ability t o be notif ied when a n annual r eport is d ue for the Safety co mmittees. | |
423 | 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. | |
424 | I have the ability t o submit a n annual r eport elec tronically for the I ACUC commi ttees. | |
425 | When neede d, I have the abilit y to submi t a tri-an nual revie w for the IACUC comm ittees. | |
426 | When neede d, I have the abilit y to submi t an ad-ho c review f or the IAC UC committ ees. | |
427 | I have the ability t o be notif ied when a n annual r eport is d ue for the IACUC com mittees. | |
428 | 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.2.11 LowPrincip al Investi gator or P I Designee To track p ublication s and awar ds with pr oject data within th e R&D, Saf ety, and I ACUC appli cations.I have the a bility to add public ations to the Bioske tch. | |
429 | I have the ability t o add awar ds to the Biosketch. | |
430 | I have the ability t o keep the Biosketch up to dat e. | |
431 | I have the ability t o create t ailored ve rsions for particula r IRB appl ications. | |
432 | I have the ability t o add publ ications t o the Bios ketch in t he R&D com mittee app lication.. | |
433 | I have the ability t o add awar ds to the Biosketch in the R&D committee applicati on. | |
434 | I have the ability t o keep the Biosketch up to dat e in the R &D committ ee applica tion.. | |
435 | I have the ability t o create t ailored ve rsions for particula r R&D appl ications. | |
436 | I have th e ability to add pub lications to the Bio sketch in the Safety committee applicati on. | |
437 | To be able to track publicatio ns and awa rds with p roject dat a. | |
438 | NOTE: PI o r PI Desig nee can re view and e dit Bioske tch online including publicati ons and aw ards secti on. | |
439 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
440 | A change r equest may be in ord er to incl ude the IR B at a lat er date.Th e table be low lists the Epic a nd detaile d User Nar ratives (B usiness Re quirements ) for BN3 / Elaborat ion Busine ss Require ment 6. | |
441 | Table 5: E pic BN3 | |
442 | Epic BN3: Enhance th e RAMS app lication t o automate the manag ement of c ommittees to ensure compliance .IDPriorit yAs a… I w ant…So tha t…Acceptan ce Criteri a/User Sto ry NotesI have the a bility to add awards to the Bi osketch | |
443 | in the Saf ety commit tee applic ation. | |
444 | I have the ability t o keep the Biosketch up to dat e in the S afety comm ittee appl ication. | |
445 | I have the ability t o create t ailored ve rsions for particula r Safety a pplication s. | |
446 | I have the ability t o add publ ications t o the Bios ketch in t he IACUC c ommittee a pplication . | |
447 | I have th e ability to add awa rds to the Biosketch | |
448 | in the IAC UC committ ee applica tion. | |
449 | I have the ability t o keep the Biosketch up to dat e in the I ACUC commi ttee appli cation. | |
450 | I have the ability t o create t ailored ve rsions for particula r IACUC ap plications .3.1/6.1Hi ghSite Sys tem Admini strator (S SA)To add or delete R&D, Safet y, and IAC UC committ ees based on site St andard Ope rating Pro cedure (SO P). | |
451 | 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.I have t he ability to config ure RAMS t o match th e R&D comm ittee rost er at my s ite. | |
452 | I have the ability t o add R&D committees that are not RAMS’s defaults. | |
453 | I have the ability t o hide R&D committee s that are not used at my site . | |
454 | I have the ability t o configur e RAMS to match the Safety com mittee ros ter at my site. | |
455 | I have the ability t o add Safe ty commit tees that are not RA MS’s defau lts. | |
456 | I have the ability t o hide Saf ety commi ttees that are not u sed at my site. | |
457 | I have the ability t o configur e RAMS to match the IACUC comm ittee rost er at my s ite. | |
458 | I have the ability t o add IACU C committe es that ar e not RAMS ’s default s. | |
459 | I have the ability t o hide IAC UC committ ees that a re not use d at my si te. | |
460 | NOTE: An o ption to a dd, delete or config ure commit tees is av ailable on the SA to ol page.Th e SSA is a ble to add or delete committee s based on the site SOP. | |
461 | NOTES: | |
462 | An option to add, de lete or co nfigure co mmittees i s availabl e on the S A tool pag e. | |
463 | 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. | |
464 | 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 . | |
465 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.2/6. 2HighCommi ttee Coord inatorTo a dd members to R&D, S afety, and IACUC com mittees, t rack meeti ng attenda nce, and t rack appoi ntment dat es.I have the abilit y to add m embers to R&D commit tees. | |
466 | I have the ability t o track R& D committe e meeting attendance . | |
467 | I have the ability t o track R& D committe e appointm ent dates. | |
468 | I have the ability t o add memb ers to Saf ety commit tees. | |
469 | I have the ability t o track Sa fety commi ttee meeti ng attenda nce. | |
470 | I have the ability t o track Sa fety commi ttee appoi ntment dat es. | |
471 | I have the ability t o add memb ers to IAC UC committ ees. | |
472 | I have the ability t o track IA CUC commit tee meetin g attendan ce. | |
473 | I have the ability t o track IA CUC commit tee appoin tment date s.Add memb ers to com mittees an d track ap pointment dates. | |
474 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.2.2/ 6.2.1HighC ommittee C oordinator To add mem bers to co mmittees, track meet ing attend ance, and track appo intment da tes – IACU C, Safety, and R&DI have the a bility to manage the IACUC com mittee ros ter. | |
475 | I have the ability t o manage m y Safety c ommittee r oster. | |
476 | I have the ability t o manage t he R&D com mittee ros ter. | |
477 | 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. | |
478 | 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. | |
479 | 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 . | |
480 | 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. | |
481 | 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. | |
482 | 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. | |
483 | 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. | |
484 | 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. | |
485 | 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. | |
486 | 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 .The Commi ttee Coord inator is able to ad d members to committ ees and tr ack appoin tment date s – IACUC, Safety, a nd R&D. | |
487 | NOTES: | |
488 | 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. | |
489 | 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. | |
490 | See VHA Ha ndbook 120 0, VHA Han dbook 1200 .05 and VH A Handbook 1200.1 fo r more det ails. | |
491 | Committee Management entails: | |
492 | Defining m embers. | |
493 | Creating a gendas. | |
494 | Scheduling meetings. | |
495 | Creating m inutes. | |
496 | Posting me etings. | |
497 | Creating t asks. | |
498 | Assigning tasks. | |
499 | Tracking t asks until completio n. | |
500 | Keeping a library of important committee documents , communic ations ann ouncements , lists, c ommittee k nowledge b ase and UR L links. | |
501 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.3/6. 3HighCommi ttee Coord inatorAdd projects, amendments , and othe r business to R&D, S afety, and IACUC com mittee age nda.I have the abili ty to add projects R &D committ ee agenda. | |
502 | I have the ability t o add amen dments R&D committee agenda. | |
503 | I have the ability t o add othe r business to R&D co mmittee ag enda. | |
504 | I have the ability t o add proj ects Safet y committe e agenda. | |
505 | I have the ability t o add amen dments Saf ety commit tee agenda . | |
506 | I have the ability t o add othe r business to Safety committee agenda. | |
507 | I have the ability t o add proj ects IACUC committee agenda. | |
508 | I have the ability t o add amen dments IAC UC committ ee agenda. | |
509 | I have the ability t o add othe r business to IACUC committee agenda.Add projects, amendment s, and oth er busines s to commi ttee agend a. | |
510 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.3.2/ 6.3.1HighC ommittee C oordinator 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 .I have th e ability to create the agenda for each R&D commit tee meetin g. | |
511 | I have the ability t o set the meeting sc hedule for each R&D committee meeting. | |
512 | I have the ability t o maintain the agend a for each R&D commi ttee meeti ng. | |
513 | I have the ability t o maintain an electr onic versi on of the R&D commit tee meetin g agenda i n order to allow mem bers to re view agend a items. | |
514 | I have the ability t o create t he agenda for each S afety comm ittee meet ing. | |
515 | I have the ability t o set the meeting sc hedule for each Safe ty committ ee meeting . | |
516 | I have the ability t o maintain the agend a for each Safety co mmittee me eting. | |
517 | 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 . | |
518 | 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. | |
519 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to crea te the age nda for ea ch IACUC c ommittee m eeting. | |
520 | I have the ability t o set the meeting sc hedule for each IACU C committe e meeting. | |
521 | I have the ability t o maintain the agend a for each IACUC com mittee mee ting. | |
522 | 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. 3.3.3/6.3. 2MediumCom mittee Coo rdinatorTo revise ag enda templ ate for R& D, Safety, and IACUC .I have th e ability to revise the agenda template for R&D co mmittees. | |
523 | I have the ability t o update t he templat e for R&D committees . | |
524 | I have the ability t o revise t he agenda template f or Safety committees . | |
525 | I have the ability t o update t he templat e for Safe ty committ ees. | |
526 | I have the ability t o revise t he agenda template f or IACUC c ommittees. | |
527 | I have the ability t o update t he templat e for IACU C committe es.The Com mittee Coo rdinator i s able to revise the agenda te mplate. Pe rmissions should be limited to not allow new field s to the a genda temp late. Pote ntial revi sions shou ld be limi ted to dro p down lis ts to main tain consi stency. | |
528 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.4/6. 4HighSite System Adm inistrator 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.I h ave the ab ility to c reate a lo cal versio n of a saf ety inform ation form for R&D c ommittee. | |
529 | I have the ability t o incorpor ate the fo rm into th e RAMS wor kflow for the R&D co mmittee. | |
530 | I have the ability t o add cust om forms t o the RAMS R&D appli cation. Th e form sho uld be pri ntable to enable upl oad and at tachment t o a study. SSA is ab le to acce ss a porta l / tools for local form creat ion and fo rm-based c ollection of safety informatio n. | |
531 | ||
532 | NOTE: The custom for ms will be added to the applic ation elec tronically . | |
533 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to crea te a local version o f a safety informati on form fo r Safety c ommittee. | |
534 | I have the ability t o incorpor ate the fo rm into th e RAMS wor kflow for the Safety committee . | |
535 | 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. | |
536 | I have the ability t o create a local ver sion of a safety inf ormation f orm for IA CUC commit tee. | |
537 | I have the ability t o incorpor ate the fo rm into th e RAMS wor kflow for the IACUC committee. | |
538 | 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. | |
539 | 3.5/6.5Hig hPrincipal Investiga tor or PI DesigneeTo automate creation o f Animal C omponent o f Research Protocol (ACORP) an d other co mpliance f orms.I hav e the abil ity to cre ate a new ACORP as a component of a stud y involvin g animals. | |
540 | ||
541 | I have the ability t o complete the ACORP online in order to expedite t he submiss ion of thi s form to the IACUC. The PI or PI Designe e is able to automat e the crea tion of AC ORP and ot her compli ance forms .3.7/6.6Hi ghCommitte e Coordina torsSchedu le meeting s and noti fy members in the R&D , Safety, and the IA CUC commit tees.I hav e the abil ity to sch edule meet ings in R& D committe es. | |
542 | I have the ability t o notify m embers in the R&D co mmittees. | |
543 | I have the ability t o schedule meetings in Safety committees . | |
544 | I have the ability t o notify m embers in the Safety committee s. | |
545 | I have the ability t o schedule meetings in IACUC c ommittees. | |
546 | I have the ability t o notify m embers in the IACUC | |
547 | committee s.Schedule meetings and notify members. | |
548 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8/6. 7HighIRB A dministrat or, Safety Committee Administr ator, R&D Administra tor, IACUC Administr atorCollec t reviewer feedbackf or R&D, Sa fety, and IACUC comm ittees.I h ave the ab ility to c ollect rev iewer feed back for R &D committ ees. | |
549 | I have the ability t o collect reviewer f eedback fo r Safety c ommittees. | |
550 | I have the ability t o collect reviewer f eedback fo r IACUC co mmittees.C ollect rev iewer feed back. | |
551 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.2/ 6.7.1HighI RB Adminis tratorTo c ollect com mittee fee dback – R& D, Safety, and IACUC .I have th e ability to monitor R&D commi ttee corre spondence. | |
552 | I have the ability t o attach t he R&D cor respondenc e to the a ppropriate study app lication. | |
553 | I have the ability t o monitor Safety com mittee cor respondenc e. | |
554 | I have the ability t o attach t he Safety correspond ence to th e appropri ate study applicatio n. | |
555 | I have the ability t o monitor IACUC comm ittee corr espondence . | |
556 | I have the ability t o attach t he IACUC c orresponde nce to the appropria te study a pplication .Reviewer comments s hould be p art of the approval letter. | |
557 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.2/ 6.7.1HighS afety Comm ittee Admi nistratorT o collect reviewer f eedback – IACUC, Saf ety, and R &D.I have the abilit y to attac h the Safe ty reviewe r comments to the ap propriate study appl ication. | |
558 | ||
559 | I have the ability t o monitor Safety rev iewer comm ents in or der to for ward reque sts for ch anges or c larificati on to the PI or PI D esignee.Th e Safety C ommittee A dministrat or is able to collec t reviewer feedback –Safety. | |
560 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.2/ 6.7.1HighR &D Adminis tratorTo c ollect rev iewer feed back – IAC UC, Safety , and R&D. I have the ability t o monitor R&D review er comment s. | |
561 | ||
562 | I have the ability t o attach t he R&D rev iewer comm ents to th e appropri ate study applicatio n. | |
563 | ||
564 | I have the ability t o monitor R&D review er comment s in order to forwar d requests for chang es or clar ification to the PI or PI Desi gnee.The R &D Adminis trator is able to co llect revi ewer feedb ack – R&D. | |
565 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.2/ 6.7.1HighI ACUC Admin istratorTo collect r eviewer fe edback – I ACUC, Safe ty, R&D.I have the a bility to monitor IA CUC review er comment s in order to forwar d requests for chang es or clar ification to the PI or PI Desi gnee.The I ACUC is ab le to coll ect review er feedbac k – IACUC. | |
566 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
567 | 3.8.3/6.7. 2HighIRB A dministrat orTo colle ct feedbac k from oth er subcomm ittees – I RB, IACUC, Safety, a nd R&D.I h ave the ab ility to m onitor cor respondenc e from oth er subcomm itteesThe IRB Admini strator is able to c ollect rev iewer feed back from other subc ommittees IRB, IACUC , Safety, and R&D. | |
568 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.3/ 6.7.2HighI ACUC Admin istratorTo collect f eedback fr om other s ubcommitte es – IRB, IACUC, Saf ety, and R &D.I have the abilit y to monit or corresp ondence fr om other s ubcommitte es.The IAC UC Adminis trator is able to co llect feed back from other subc ommittees – IRB, Saf ety, and R &D. | |
569 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.3/ 6.7.2HighS afety Comm ittee Admi nistratorT o collect feedback f rom other subcommitt ees – IRB, IACUC, Sa fety, and R&D.I have the abili ty to moni tor corres pondence f rom other subcommitt ees.The Sa fety Commi ttee Admin istrator i s able to collect fe edback fro m other su bcommittee s – IRB, I ACUC, and R&D. | |
570 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.8.3/ 6.7.2HighR &D Committ ee Adminis tratorTo c ollect fee dback from other sub committees – IRB, IA CUC, Safet y, and R&D .I have th e ability to monitor correspon dence from other sub committees .The R&D C ommittee A dministrat or is able to collec t feedback from othe r subcommi ttees –IRB , IACUC, a nd Safety. | |
571 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.9/6. 8HighRAMS UserTo pro vide a mec hanism for the use o f secure e lectronic signatures for the s igning of all forms and corres pondence f or R&D, Sa fety, and IACUC comm ittees.I h ave the ab ility to s ign docume nts electr onically a s part of the study applicatio n. | |
572 | ||
573 | I have the ability t o sign doc uments ele ctronicall y as part of the app roval proc ess. | |
574 | ||
575 | I have the ability t o sign doc uments ele ctronicall y to avoid printing of paper d ocuments. | |
576 | ||
577 | I have the ability t o sign doc uments ele ctronicall y to avoid distribut ion of pap er documen ts. | |
578 | ||
579 | I have the ability t o sign doc uments ele ctronicall y to avoid storage o f paper do cuments. | |
580 | ||
581 | NOTE: User can choos e to sign electronic ally when submitting a documen t that req uires sign ature.Prov ide the RA MS User wi th a mecha nism for t he use of secure ele ctronic si gnatures f or the sig ning of al l forms an d correspo ndence. | |
582 | ||
583 | NOTE: | |
584 | The goal i s to get t he signatu res electr onically m andated bu t not sure if that w ill happen . | |
585 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.10/6 .9HighComm ittee Coor dinatorTo publish, s tore, and upload dra ft and fin al version s of meeti ng minutes for the R &D, Safety , and IACU C committe es.I have the abilit y to publi sh meeting minutes f or R&D com mittees. | |
586 | I have the ability t o | |
587 | store minu tes of mee tings for R&D commit tees.Publi sh and sto re minutes of meetin gs | |
588 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to uplo ad draft v ersions of meeting m inutes for the R&D c ommittees. | |
589 | I have the ability t o upload f inal versi ons of mee ting minut es for the R&D commi ttees. | |
590 | I have the ability t o publish meeting mi nutes for Safety com mittees. | |
591 | I have the ability t o | |
592 | store minu tes of mee tings for Safety com mittees. | |
593 | I have the ability t o upload d raft versi ons of mee ting minut es for the Safety co mmittees. | |
594 | I have the ability t o upload f inal versi ons of mee ting minut es for the Safety co mmittees. | |
595 | I have the ability t o publish meeting mi nutes for IACUC comm ittees. | |
596 | I have the ability t o | |
597 | store minu tes of mee tings for IACUC comm ittees.. | |
598 | I have the ability t o upload d raft versi ons of mee ting minut es for the IACUC com mittees. | |
599 | I have the ability t o upload f inal versi ons of mee ting minut es for the IACUC com mittees.3. 10.2/6.9.1 HighCommit tee Coordi natorTo pu blish, sto re, and up load draft and final versions of meeting minutes – IACUC, Sa fety, and R&DI have the abilit y to creat e IACUC mi nutes of m eetings. | |
600 | I have the ability t o edit IAC UC minutes of meetin gs. | |
601 | I have the ability t o archive IACUC minu tes of mee tings. | |
602 | I have the ability t o create S afety minu tes of mee tings. | |
603 | I have the ability t o edit Saf ety minute s of meeti ngs. | |
604 | I have the ability t o archive Safety min utes of me etings. | |
605 | I have the ability t o create R &D minutes of meetin gs. | |
606 | I have the ability t o edit R&D minutes o f meetings . | |
607 | I have the ability t o archive R&D minute s of meeti ngs | |
608 | I have the ability t o ensure t hat IACUC meeting mi nutes are available online to Users who have appro priate per missions. | |
609 | I have the ability t o ensure t hat IACUC meeting mi nutes are accessible to Users who have a ppropriate permissio ns. | |
610 | I have the ability t o ensure t hat Safety meeting m inutes are available online to Users who have appr opriate pe rmissions. | |
611 | I have the ability t o ensure t hat Safety meeting m inutes are accessibl e to Users who have appropriat e permissi ons. | |
612 | 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. | |
613 | 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 .The Commi ttee Coord inator is able to pu blish and store minu tes of mee tings – IA CUC, Safet y, and R&D . | |
614 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.10.3 /6.9.2Medi umIACUC Co mmittee Co ordinatorT o edit min utes forma tI have th e ability to revise the format of IACUC meeting mi nutes.The IACUC Comm ittee Coor dinator is able to r evise the format of IACUC minu tes format .3.10.3/6. 9.2MediumS afety Comm ittee Coor dinatorTo edit minut es formatI have the ability to revise th e format o f Safety m eeting min utes.The S afety Comm ittee Coor dinator is able to r evise the format of Safety min utes forma t.3.10.3/6 .9.2Medium R&D Commit tee Coordi natorTo ed it minutes formatI h ave the ab ility to r evise the format of R&D meetin g minutes. The R&D Co mmittee Co ordinator is able to revise th e format o f R&D minu tes format .3.12/6.10 HighIACUC Administra tor, Safet y Committe e Administ rator and R&D Commit tee Admini stratorPro vide IACUC , Safety a nd R&D man agement Ca pabilityI have the a bility to comply wit h Federal and VA reg ulations f or R&D com mittees. | |
615 | I have the ability t o comply w ith Federa l and VA r egulations for Safet y committe es. | |
616 | I have the ability t o comply w ith Federa l and VA r egulations for IACUC committee s.To adequ ately sati sfy all Fe deral and VA regulat ions gover ning the m anagement of the R&D , Safety, and IACUC committees to includ e computer usage, st orage, and security. | |
617 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.12/6 .10.1HighI ACUC Admin istrator T o be able to manage all aspect s of his/h er IACUC c ommittee t o ensure c ompliance with Feder al and VA regulation s. This in cludes sch edules, me etings, no tification s, minutes , and docu ments.I ha ve the abi lity to co mply with Federal an d VA regul ations in the IACUC committees .Provide m anagement capability - This in cludes sch edules, me etings, no tification s, minutes , and docu ments .3.1 2/6.10.1Hi ghSafety C ommittee A dministrat orTo be ab le to mana ge all asp ects of hi s/her Safe ty committ ee to ensu re complia nce with f ederal and VA regula tions. Thi s includes schedules , meetings , notifica tions, min utes, and documents. I have the ability t o comply w ith Federa l and VA r egulations in the Sa fety commi ttees.Prov ide manage ment capab ility - Th is include s schedule s, meeting s, notific ations, mi nutes, and documents .3.12/6.1 0.1HighR&D Committee Administr atorTo be able to ma nage all a spects of his/her R& D committe e to ensur e complian ce with fe deral and VA regulat ions. This includes schedules, meetings, notificat ions, minu tes, and d ocuments.I have the ability to comply wi th Federal and VA re gulations in the R&D committee s.Provide management capabilit y - This i ncludes sc hedules, m eetings, n otificatio ns, minute s, and doc uments.3.1 3/6.11High Committee Coordinato rTo track reporting of adverse events, p rotocol de viations, and protoc ol excepti ons in the R&D, Safe ty, and IA CUC commit tees.I hav e the abil ity to com ply with F ederal rev iew events submitted from the PI or PI D esignee re garding ad verse even ts, protoc ol deviati ons, and V A regulati ons in the R&D commi ttees. | |
618 | 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. | |
619 | Track repo rting of a dverse eve nts, proto col deviat ions, and protocol e xceptions. | |
620 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to comp ly with Fe deral revi ew events submitted from the P I or PI De signee reg arding adv erse event s, protoco l deviatio ns, and VA regulatio ns in the IACUC comm ittees.3.1 3.2/6.11.1 HighCommit tee Coordi natorTo tr ack report ing of adv erse event s, protoco l deviatio ns, and pr otocol exc eptions – IACUC,IRB, SRS, and R&D.I have the abili ty to trac k notifica tion regar ding adver se events and protoc ol deviati ons in IRB committee s. | |
621 | I have the ability t o coordina te notific ation rega rding adve rse events and proto col deviat ions in IR B committe es. | |
622 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eportsin I RB committ ees. | |
623 | I have the ability t o maintain records o f notifica tions for filing of required r eports in IRB commit tees. | |
624 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in IACUC c ommittees. | |
625 | 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.. | |
626 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports in IACUC comm ittees.. | |
627 | I have the ability t o maintain records o f notifica tions for filing of required r eports.The Committee Coordinat or is able to track reporting of adverse events, p rotocol de viations, and protoc ol excepti ons – IACU C, IRB, an d SRS. | |
628 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to main tain recor ds of noti fications for filing of requir ed reports in IACUC committees . | |
629 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in R&D com mittees. | |
630 | 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.. | |
631 | 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.. | |
632 | I have the ability t o maintain records o f notifica tions for filing of required r eports in R&D commit tees. | |
633 | I have the ability t o track no tification regarding adverse e vents and protocol d eviations in Safety committees . | |
634 | I have the ability t o coordina te notific ation rega rding adve rse | |
635 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports. | |
636 | I have the ability t o maintain records o f notifica tions for filing of required r eports.eve nts and pr otocol dev iations in Safety co mmittees. | |
637 | I have the ability t o maintain records o f adverse event docu ments for filing of required r eports in Safety com mittees. | |
638 | I have the ability t o maintain records o f notifica tions for filing of required r eports in Safety com mittees.3. 15/6.12Med iumPI or P I Designee To generat e investig ational dr ug informa tion recor d (Form 10 -9012) for the R&D, Safety and IACUC com mittees.I have the a bility to complete F orm 10-901 2 in the R &D committ ees. | |
639 | I have the ability t o attach F orm 10-901 2 to a stu dy applica tion in th e R&D comm ittees. | |
640 | I am promp ted when a n Investig ational Dr ug form is required in the R&D committee s. | |
641 | 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 R&D com mittees. | |
642 | ||
643 | I have the ability t o complete Form 10-9 012 in the Safety co mmittees. | |
644 | I have the ability t o attach F orm 10-901 2 to a stu dy applica tion in th e Safety c ommittees. | |
645 | I am promp ted when a n Investig ational Dr ug form is required in the Saf ety commit tees. | |
646 | 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 . | |
647 | ||
648 | PI or PI D esignee is able to g enerate in vestigatio nal drug i nformation record (F orm 10-901 2) | |
649 | ||
650 | After the form is ge nerated, a signature is requir ed by the R&D and IR B chairs. | |
651 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to comp lete Form 10-9012 in the IACUC committee s. | |
652 | I have the ability t o attach F orm 10-901 2 to a stu dy applica tion in th e IACUC co mmittees. | |
653 | I am promp ted when a n Investig ational Dr ug form is required in the IAC UC committ ees. | |
654 | 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. | |
655 | 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.3.16 /6.13HighC ommittee C oordinator 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.I h ave the ab ility to n otify the PI or PI D esignee 60 days befo re a study expires t hat a cont inuing rev iew/annual report is due in R& D committe es. | |
656 | 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. | |
657 | 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.Th e PI or PI Designee is notifie d when ann ual renewa ls of subc ommittee r eviews are due. | |
658 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.16.2 /6.13.1Hig hPI or PI DesigneeTo be notifi ed when an nual renew als of sub committee reviews ar e done – I ACUC and I RBI am not ified when an annual review is due in or der to com plete the annual rev iew of a s tudy and s ubmit in I ACUC. | |
659 | ||
660 | I am notif ied 90 day s before a study exp ires to su bmit Annua l Report i n IACUC.PI or PI Des ignee is n otified wh en annual renewals o f subcommi ttee revie ws are don e – IACUC3 .17/6.14Me diumAO and Committee Coordinat orsTo trac k Federal- wide Assur ances, IRB , R&D, Saf ety, and I ACUC regis trations, Memorandum s of Under standing ( MOUs), and other acc reditation s in R&D, Safety, an d IACUC co mmittees.I have the ability to track Ass urances in the R&D c ommittees. | |
661 | I have the ability t o track MO Us in the R&D commit tees.. | |
662 | I have the ability t o track ot her accred itations i n the R&D committees . | |
663 | I have the ability t o monitor assurances in order to ensure compliance with Fede ral and VA regulatio ns in the R&D commit tees. | |
664 | 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 R&D co mmittees. | |
665 | 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 R&D co mmittees. | |
666 | I have the ability t o track As surances i n the Safe ty committ ees. | |
667 | I have the ability t o track MO Us in the Safety com mittees. | |
668 | I have the ability t o track ot her accred itations i n the Safe ty committ ees. | |
669 | I have the ability t o monitor assurances in order to ensure compliance with Fede ral and VA regulatio ns. | |
670 | I have the ability t o monitor MOUs in or der to ens ure compli ance with Federal | |
671 | . | |
672 | ||
673 | NOTE: Assu rance and Accreditat ion Checkl ist is pro vided on A O landing page.The A O is able to track F ederal Wid e Assuranc es, IRB an d IACUC re gistration s, MOUs, a nd other a ccreditati ons. | |
674 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.and VA regulatio ns in the Safety com mittees. | |
675 | I have the ability t o monitor | |
676 | accreditat ions in or der to | |
677 | ensure com pliance wi th | |
678 | Federal an d VA | |
679 | Regulation s in the S afety comm ittees. | |
680 | I have the ability t o track As surances i n the IACU C committe es. | |
681 | I have the ability t o track MO Us in the IACUC comm ittees. | |
682 | I have the ability t o track ot her accred itations i n the IACU C committe es. | |
683 | 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. | |
684 | 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 . | |
685 | 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 .3.18/6.15 HighLA (Lo cal System Administr ator)To al low for si te specifi c committe e configur ations and workflows in the R& D, Safety, and IACUC committee s.I have t he ability to config ure the wo rkflow for each R&D committee. | |
686 | I have the ability t o configur e the work flow for e ach Safety committee . | |
687 | I have the ability t o configur e the work flow for e ach IACUC committee. The LA is able to im plement si te specifi c committe e configur ations and workflows . | |
688 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.18/6 .15HighSAT o allow fo r site spe cific comm ittee conf igurations and workf lows R&D, Safety, an d IACUC co mmittees.I have the ability to configure the workf lows withi n and amon g R&D comm ittees in order to c omply with local sit uation and SOPs. | |
689 | 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. | |
690 | 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. | |
691 | ||
692 | NOTE: Work flow confi guration t ool is ava ilable on the LSA la nding page .The SA is able to i mplement s ite-specif ic committ ee configu rations an d workflow s | |
693 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.19/6 .16MediumR COProvide compliance checklist for RCO a nd the Saf ety commit tees.The R CO should be able to have a ve rsion of t he ORO che cklist onl ine. | |
694 | ||
695 | The RCO sh ould be ab le to have an online version o f the chec klist avai lable in o rder to co mplete com pliance re ports. | |
696 | The Safety committee should be able to h ave a vers ion of the ORO check list onlin e. | |
697 | 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. | |
698 | ||
699 | NOTE: Chec klist is a vailable o n RCO land ing page.T he RCO is able to ob tain the c ompliance checklist online.3.2 /6.17HighP I or PI De signeeAuto mate creat ion of Res earch Prot ocol Safet y Survey ( RPSS) (VA Form 10-03 98)The PI or PI Desi gnee must be able to submit Fo rm 10-0398 as a comp onent of a study app lication. | |
700 | ||
701 | The PI or PI Designe e must be able to co mplete the Safety Su rvey in or der to det ermine whi ch types o f safety r eviews may be requir ed. | |
702 | ||
703 | NOTE: A li nk is avai lable in t he online study appl ication to access an d complete Form 10-0 398 (for I RB only)Th e PI or PI Designee is able to access, f ill out an d submit a n automate d Research Protocol Safety Sur vey (RPSS) (VA Form 10-0398) o nline.3.21 /6.18HighA ssociate C hief of St aff (ACOS) To be prov ided with a landing page for A COS and AO in the R&D , Safety, and IACUC committees .The ACOS will be pr ovided wit h a landin g page in the R&D co mmittees. | |
704 | The ACOS w ill be pro vided with a landing page in t he Safety committees . | |
705 | The ACOS w ill be pro vided with a landing page in t he IACUC c ommittees. The ACOS w ill be pro vided with a landing page. | |
706 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.3.21/6 .18HighAOT o be provi ded with a landing p age for AC OS and AO in the R&D , Safety, and the IA CUC commit tees. | |
707 | AO – Admin istrative Officer | |
708 | ACOS - Ass istant Chi ef of Staf f The AO w ill be pro vided with a landing page in t he R&D com mittees. | |
709 | The AO wil l be provi ded with a landing p age in the Safety co mmittees. | |
710 | The AO wil l be provi ded with a landing p age in the IACUC com mittees.Th e AO will be provide d with a l anding pag e. | |
711 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.The ta ble below lists the Epic and d etailed Us er Narrati ves (Busin ess Requir ements) fo r BN4/Elab oration Bu siness Req uirement 7 . | |
712 | Table 6: E pic BN4 | |
713 | Epic BN4: Manage dat a about pe rsonnel en gaged in r esearch at VAMC faci lities.IDP riorityAs a… I want… So that…Ac ceptance C riteria/Us er Story N otes4.2Hig h – automa te connect ions betwe en Collabo rative Ins titutional Training (CITI), Ta lent Manag ement Syst em (TMS) a nd RAMSPri ncipal Inv estigator or PI Desi gnee and C ommittee C oordinator sTo 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 i n the R&D, Safety, a nd IACUC c ommittees. I have the ability t o track th e training status of personnel attached to a study in the R& D committe e. | |
714 | 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 R&D c ommittee. | |
715 | 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 R&D com mittee. | |
716 | I have the ability t o track th e training status of personnel attached to a study in the Sa fety commi ttee. | |
717 | 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 . | |
718 | 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. | |
719 | I have the ability t o track th e training status of personnel attached to a study in the IA CUC commit tee. | |
720 | 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. | |
721 | 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.T o be able 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. | |
722 | ||
723 | NOTE: A tr aining rec ord is ava ilable for research personnel and notifi cations ar e sent to the PI or PI Designe e and User when trai ning is ab out to exp ire. | |
724 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.4.3Med iumPrincip al Investi gator or P I Designee | |
725 | and RAMS U serTo noti fy PI or P I Designee and emplo yee when t raining is required including annual/bia nnual re-t raining in the R&D, Safety, an d IACUC co mmittees.I have the ability to have a li nk to refe rence what training is require d for ever y assigned research task in th e R&D comm ittee. | |
726 | 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 R&D committee . | |
727 | 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 R&D committee. | |
728 | 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. | |
729 | 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. | |
730 | 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. | |
731 | 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. | |
732 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to have a | |
733 | link to re ference wh at | |
734 | training i s required for every assigned research | |
735 | task in th e IACUC co mmittee. | |
736 | I have the ability t o be | |
737 | notified i f a team m ember’s tr aining is | |
738 | about to e xpire in o rder to ma intain a q ualified s taff in th e IACUC co mmittee. | |
739 | I have the ability t o have a | |
740 | link to kn ow what tr aining is required f or my assi gned resea rch tasks in the IAC UC committ ee.4.4Medi umAdminist rative Off icerTo not ify Withou t Compensa tion (WOC) /In-Person Authentic ation (IPA )/VA emplo yee and sp onsor when appointme nt renewal is requir ed in the R&D, Safet y, and IAC UC committ ees.I have the abili ty to be i nformed wh en WOC emp loyee appo intments a re about t o expire i n the R&D committee. | |
741 | I have the ability t o monitor WOC appoin tments to ensure all research staff is q ualified i n the R&D committee. | |
742 | 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. | |
743 | 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. | |
744 | 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. | |
745 | 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.To be ab le to noti fy WOC/IPA /VA employ ee and spo nsor when appointmen t renewal is require d. | |
746 | ||
747 | NOTE: Repo rt of WOC staff and appointmen t status i s availabl e from AO landing pa ge. | |
748 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.4.5Low Administra tive Offic erTo track key, pers onal compu ter (PC), and badge assignment s/issues i n the R&D, Safety, a nd the IAC UC committ ees.I have the abili ty to acce ss data th at links p ersonnel t o badges i n the R&D committee. | |
749 | I have the ability t o access d ata that l inks perso nnel to ke ys in the R&D commit tee. | |
750 | I have the ability t o access d ata that l inks perso nnel to eq uipment in the R&D c ommittee. | |
751 | 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. | |
752 | 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 R&D committee . | |
753 | I have the ability t o access d ata that l inks perso nnel to ba dges in th e Safety c ommittee. | |
754 | I have the ability t o access d ata that l inks perso nnel to ke ys in the Safety com mittee. | |
755 | To be able to track key, PC, a nd badge a ssignments /issues. | |
756 | ||
757 | NOTE: Repo rt of key, badges, a nd equipme nt assigne d to perso nnel is av ailable on the AO la nding page . | |
758 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to acce ss data th at links p ersonnel t o equipmen t in the S afety comm ittee. | |
759 | I have the ability t o ensure t hat badges are assig ned to the | |
760 | appropriat e personne l in order to mainta in physica l | |
761 | security i n the Safe ty committ ee. | |
762 | I have the ability t o ensure t hat keys a re | |
763 | assigned t o the appr opriate pe rsonnel in | |
764 | order to m aintain ph ysical sec urity in t he Safety committee. | |
765 | I have the ability t o access d ata that l inks perso nnel to ba dges in th e IACUC co mmittee. | |
766 | I have the ability t o access d ata that l inks perso nnel to ke ys in the IACUC comm ittee. | |
767 | I have the ability t o access d ata that l inks perso nnel to eq uipment in the IACUC committee . | |
768 | 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. | |
769 | 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.4.6LowA dministrat ive Office rTo track and certif y effort o n projects in the R& D, Safety, and the I ACUC commi ttees.I ha ve the abi lity to mo nitor labo r charged to researc h projects at a stat ion for th e R&D comm ittee. | |
770 | I have the ability t o monitor effort on projects t o avoid co st overrun s for the R&D commit tee. | |
771 | 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. | |
772 | I have the ability t o monitor effort on projects t o avoid co st overrun s for the Safety com mittee. | |
773 | 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. | |
774 | I have the ability t o monitor effort on projects t o avoid co st overrun s for the IACUC comm ittee.To b e able to track and certify ef fort on pr ojects. | |
775 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.4.7Med iumCommitt ee Coordin atorTo tra ck COI Dis closures i n the R&D, Safety, a nd IACUC c ommittees. 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 . | |
776 | 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. | |
777 | 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.To be a ble to tra ck COI Dis closures. | |
778 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.4.8Hig hPrincipal Investiga tor or PI DesigneeTo add perso nnel to st udy team; set roles and notifi cationsin the R&D, S afety, and IACUC com mittees.I have the a bility to add person nel to the study tea m in the R &D committ ees. | |
779 | I have the ability t o set role s for each study in the R&D co mmittees. | |
780 | I have the ability t o add pers onnel to t he study t eam in the Safety co mmittees. | |
781 | I have the ability t o set role s for each study in the Safety committee s.. | |
782 | I have the ability t o add pers onnel to t he study t eam in the IACUC com mittees. | |
783 | I have the ability t o set role s for each study in the IACUC committees .To be abl e to add p ersonnel t o study te am; set ro les and no tification s. | |
784 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.4.9Hig hCommittee Coordinat orTo recei ve a notif ication wh en changes or additi ons are ma de to the study team in the R& D, Safety, and IACUC committee s.I can be aware of additions of changes made by t he PI or P I Designee in the R& D committe es. | |
785 | 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. | |
786 | 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.To rece ive notifi cations wh en personn el are add ed/removed from the study team . | |
787 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.The ta ble below lists the Epic and d etailed Us er Narrati ves (Busin ess Requir ements) fo r BN5/Elab oration Bu siness Req uirement 8 . | |
788 | Table 7: E pic BN5 | |
789 | Epic BN5: Manage dat a about la boratory s pace and s afety.IDPr iorityAs a … I want…S o that…Acc eptance Cr iteria/Use r Story No tes5.1Medi umAdminist rative Off icerTo tra ck laborat ory space allocation s R&D, Saf ety, and I ACUC commi ttees.I ha ve the abi lity to ha ve data ab out how la b space is allocated and who i s responsi ble for ea ch lab in the R&D co mmittee. | |
790 | 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 R&D commit tee. | |
791 | 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.. | |
792 | 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. | |
793 | 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. | |
794 | 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.To b e able to track labo ratory spa ce allocat ions. | |
795 | ||
796 | NOTE: Lab Space Repo rt is acce ssible fro m the AO l anding pag e. | |
797 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.5.2Med iumPrincip al Investi gator or P I Designee To add dat a to labor atory insp ection for m in the S afety comm ittees.I h ave the ab ility to t rack lab i nspections in the Sa fety commi ttees. | |
798 | ||
799 | I have the ability t o record l ab inspect ions in th e Safety c ommittees. | |
800 | ||
801 | 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.To be able t o add data to labora tory inspe ction form . | |
802 | ||
803 | NOTE: Atla nta VAMC L ASIF form available online as a componen t of RAMS. 5.3MediumA dministrat ive Office r | |
804 | and Princi pal Invest igator or PI Designe eTo genera te and tra ck annual lab safety self-eval uation for ms and lab safety in the Safet y committe es.I have the abilit y to track various l ab safety reports in the Safet y committe es. | |
805 | ||
806 | 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.To be able t o generate and track annual la b safety s elf-evalua tion forms and lab s afety. | |
807 | ||
808 | NOTE: LASI F form ava ilable onl ine as a c omponent o f RAMS.5.4 MediumPrin cipal Inve stigator o r PI Desig neeTo main tain inven tory of ch emicals, s elect agen ts, and bi ohazards o f the Safe ty commite e.I have t he ability to monito ry invento ry of chem icals in t he Safety committees . | |
809 | ||
810 | I have the ability t o monitor inventory of biohaza rds in the Safety co mmittees. | |
811 | ||
812 | I have the ability t o access d ata detail ing stored chemicals in order to comply with Feder al regulat ions in th e Safety c ommittees. | |
813 | ||
814 | I have the ability t o access d ata detail ing stored miscellan eous agent s in order to comply with Fede ral regula tions in t he Safety committees . | |
815 | ||
816 | I have the ability t o specify if materia ls are lab specific in the Saf ety commit tees.To be able to m aintain in ventory of chemicals , select a gents, and biohazard s.5.5Mediu mAdministr ative Offi cerTo mana ge tissue bank locat ion data i n the R&D, Safety an d IACUC co mmittees.I have the ability to monitor i nformation about a t issue bank in the R& D committe es. | |
817 | ||
818 | I have the ability t o monitor informatio n about a tissue ban k in the S afety comm ittees. | |
819 | I have the ability t o monitor informatio n about a tissue ban k in the I ACUC commi ttees. | |
820 | To be able to manage tissue-ba nking data . | |
821 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.5.6Med iumAdminis trative Of ficerTo ma nage data sharing ag reements, data repos itory appr ovals, and annual re ports in t he R&D, Sa fety, and IACUC comm ittees.I h ave the ab ility to m anage elec tronic ver sions of d ata sharin g agreemen ts in the R&D commit tees. | |
822 | I have the ability t o manage e lectronic versions o f data rep ository ag reements i n the R&D committees . | |
823 | I have the ability t o have leg al prepare d reviews that requi re MOU agr eements in the R&D c ommittees. | |
824 | I have the ability t o have reg ulatory re views that require M OU agreeme nts in the R&D commi ttees. | |
825 | I have the ability t o have reg ulatory re views that require d ata sharin g agreemen ts in the R&D commit tees. | |
826 | I have the ability t o manage e lectronic versions o f data sha ring agree ments in t he Safety committees . | |
827 | I have the ability t o manage e lectronic versions o f data rep ository ag reements i n the Safe ty committ ees. | |
828 | To be able to manage data shar ing agreem ents, data repositor y approval s, and ann ual report s. | |
829 | ||
830 | NOTE: Data sharing a greements are stored as tagged documents . | |
831 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.I have the abili ty to have legal pre pared revi ews that r equire MOU agreement s in the S afety comm ittees. | |
832 | I have the ability t o have | |
833 | regulatory reviews t hat requir e MOU agre ements in the Safety committee s. | |
834 | I have the ability t o have reg ulatory re views that require d ata sharin g | |
835 | Agreements in the Sa fety commi ttees. | |
836 | I have the ability t o manage e lectronic versions o f data sha ring agree ments in t he Safety committees . | |
837 | I have the ability t o manage e lectronic versions o f data rep ository ag reements i n the Safe ty committ ees. | |
838 | I have the ability t o have leg al prepare d reviews that requi re MOU agr eements in the Safet y committe es. | |
839 | I have the ability t o have reg ulatory re views that require M OU agreeme nts in the Safety co mmittees. | |
840 | I have th e ability to have re gulatory r eviews tha t require data shari ng agreeme nts in the Safety co mmittees.5 .7MediumAn imal Facil ity Manage r (AFM)To manage ani mal census in the IA CUC and Sa fety commi ttee.I hav e the abil ity to mai ntain a ce nsus of an imals stor ed in our Veterinary Medical U nit (VMU) in the IAC UC committ ees. | |
841 | ||
842 | I have the ability t o maintain an up-to- date anima l census t o ensure t hat animal s are avai lable for studies in the Safet y committe es. | |
843 | ||
844 | I have the ability t o ensure t he AFM is a role in RAMS and i n the Safe ty committ ees..To be able to m anage anim al census. 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. | |
845 | Table 8: E pic BN6 | |
846 | Epic BN6: Central Of fice repor ting requi rements.ID PriorityAs a… I want …So that…A cceptance Criteria/U ser Story Notes6.1Me diumAdmini strative O fficerTo c reate real -time expe nditure re ports R&D, Safety, a nd IACUC c ommittees. I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the R&D commi ttees. | |
847 | 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 R&D com mittees.. | |
848 | I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the Safety co mmittees. | |
849 | 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 . | |
850 | I have the ability t o complete reports t hat detail expenditu res by Fis cal Year ( FY) in the IACUC com mittees. | |
851 | 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. To be able to create real-time expenditu re reports . | |
852 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.6.2Hig hAdministr ative Offi cerTo prov ide query and report ing tools for admini strative r esearch da ta in the R&D, Safet y and IACU C.I have t he ability to respon d to data requests f rom Centra l Office i n the R&D committees . | |
853 | I have the ability t o respond to status requests f rom Centra l Office i n the R&D committees . | |
854 | I have the ability t o respond to data re quests fro m Central Office in the Safety committee s. | |
855 | I have the ability t o respond to status requests f rom Centra l Office i n the Safe ty committ ees. | |
856 | I have the ability t o respond to data re quests fro m Central Office in the IACUC committees . | |
857 | I have the ability t o respond to status requests f rom Centra l Office i n the IACU C committe es.To be a ble to pro vide query and repor ting tools for admin istrative research d ata. | |
858 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.6.12Hi ghRAMS Use rTo 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 in the R&D , Safety, and IACUC committees .I have th e ability to export data for u se in Micr osoft (MS) Excel and other ana lysis pack ages in th e R&D comm ittees. | |
859 | I have the ability t o export d ata for us e in other analysis packages i n the R&D committees . | |
860 | I have the ability t o export d ata to MS PowerPoint in order to make pr esentation graphs in the R&D c ommittees. | |
861 | 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. | |
862 | I have the ability t o export d ata for us e in other analysis packages i n the Safe ty committ ees. | |
863 | 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. | |
864 | 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. | |
865 | 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. | |
866 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.Table 9: Epic BN 7 | |
867 | Epic BN7: System wil l interfac e with VA systemsIDP riorityAs a… I want… So that…Ac ceptance C riteria/Us er Story N otesI have the abili ty to expo rt data fo r use in o ther analy sis packag es in the IACUC comm ittees. | |
868 | I have the ability t o export d ata to MS PowerPoint in order to make pr esentation graphs in the IACUC committee s.7.2/10.2 MediumAdmi nistrative Officerto support a utomated d ata import from Coll aborative Institutio nal Traini ng (CITI). the CITI s ystem must interface with RAMS and the C ITI traini ng data wi ll availab le to RAMS users.The AO is abl e to acces s data in CITI using RAMS.7.5/ 10.5Medium Administra tive Offic erto suppo rt automat ed data im port from Talent Man agement Sy stem (TMS) .the TMS m ust interf ace with R AMS in ord er to acce ss the RAM S training records.T he AO is a ble to acc ess data i n TMS usin g RAMS.The table bel ow lists t he Epic an d detailed User Narr atives (Bu siness Req uirements) for BN8. This Busin ess Requir ement was not in the initial B usiness Re quirements Document (BRD). Upd ates will be made to the BRD. The table below was not includ ed in the initial Re search Off ice, all c ommitteesE laboration Business Requiremen ts documen t. | |
869 | Table 10: Epic BN8 | |
870 | Epic BN8: The system will crea te a Docum ent Manage ment Proce ss. IDPrio rityAs a…I want…So t hat…Accept ance Crite ria\User S tory Notes 8.1HighAdm inistrativ e Officer | |
871 | Associate Chief of S taff for R esearch | |
872 | Committee Coordinato r/ | |
873 | Committee Administra tor | |
874 | Principle Investigat or or PI D esignee | |
875 | Co-Princip le Investi gator | |
876 | IRB Admini strator | |
877 | IRB Chair | |
878 | IRB Member | |
879 | IRB Staff | |
880 | Local Site | |
881 | Investigat or (CIRB R ole Only) | |
882 | Local RAMS Administr ator | |
883 | Study Coor dinator | |
884 | ORD Admini stratorThe system to allow edi ting, prin ting, and storage of IRB, IACU C, R&D and Safety do cuments.Th e system m ust allow editing of IRB docum ents. | |
885 | The system must allo w printing of IRB do cuments. | |
886 | The system must allo w storage of IRB doc uments. | |
887 | The system must allo w editing of IACUC d ocuments. | |
888 | The system must allo w printing of IACUC documents. | |
889 | The system must allo w storage of IACUC d ocuments. | |
890 | The system must allo w editing of R&D doc uments. | |
891 | The system must allo w printing of R&D do cuments. | |
892 | The system must allo w storage of R&D doc uments. | |
893 | The system must allo w editing of Safety documents. | |
894 | The system must allo w printing of Safety documents . | |
895 | The system must allo w storage of Safety documents. The system will succ essfully e dit, print , and stor e document s for each committee . | |
896 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.The ta ble below lists the Epic and d etailed Us er Narrati ves (Busin ess Requir ements) fo r BN8. Thi s Business Requireme nt was not in the in itial Busi ness Requi rements Do cument (BR D). Update s will be made to th e BRD. The table bel ow was not included in the ini tial Elabo ration Bus iness Requ irements d ocument. | |
897 | Table 11: Epic BN9 | |
898 | Epic BN9: Develop a Reporting Management ModuleIDP riorityAs a…I want… So that…Ac ceptance C riteria/Us er Story N otes9.1Hig hCommittee Coordinat or/Committ ee Adminis trator, IR B Administ rator, IRB StaffTo i ntegrate a complete reporting capability for User defined an d pre-defi ned genera ted report s in the R &D, Safety , and IACU C committe es.I have tracking c apabilitie s for nece ssary R&D committee activity. | |
899 | I have tra cking capa bilities f or necessa ry Safety committee activity. | |
900 | I have tra cking capa bilities f or necessa ry IACUC c ommittee a ctivity.I have track ing capabi lities for necessary committee activity. | |
901 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.2Hig hAdministr ative Offi cer, | |
902 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator, IRB Administr ator, IRB Staff | |
903 | To see a s tudy listi ng by Loca l Site in the R&D, S afety, and IACUC com mittees.Re ports can be printed out by si te listing all of th e studies open at th ose sites to include IRB Numbe r, funding agency, s tudy title , the LSI/ Co-LSIs, a pproval da te, and co ntinuing r eview expi ration dat e in the I RB committ ees. | |
904 | 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. | |
905 | 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. | |
906 | 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. 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. | |
907 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.3Hig hCommittee Coordinat or/ Commit tee Admini strator, I RB Adminis trator, IR B StaffTo retrieve a n Active s tudy listi ng in the R&D, Safet y, and IAC UC committ ees.A list ing of all active st udies can be retriev ed by IRB number, fu nding sour ce, whethe r study is FDA-regul ated, stud y title, n umber of s ites, PI/C o-PIs, Pri mary Revie wer, Assig ned VA Cen tral IRB M anger, Ris k Level, A pproval Da te, Contin uing Revie w, and App roval Expi ration Dat e. (I am a ssuming th at we will be able t o sort thi s particul ar report to run a r eport, for example, only FDA-r egulated s tudies or only studi es funded by CSP in the R&D co mmittees. | |
908 | 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. | |
909 | To retriev e an Activ e study li sting. | |
910 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.partic ular repor t to run a report, f or example , only FDA - regulate d studies or only st udies fund ed by CSP in the Saf ety commit tees. | |
911 | 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.9.4 HighCommit tee Coordi nator/ Com mittee Adm inistrator , R&D Admi nistrator, R&D Staff , Safety A dministrat or, Safety Staff, IA CUC Admini strator, I ACUC Staff To retriev e an Exped ited Listi ng in the R&D, Safet y, and IAC UC committ ees.A repo rt can be run for a specified period of time to re port all s tudy actio n approved under exp edited pro cedures fo r the next Board mee ting in th e R&D comm ittees. Th is include s approval of new st udies, loc al sites, continuing reviews o f both PI and LSI Ap plications , and PI a nd LSI Ame ndments, a s well as review and action ta ken on UAP , SAE, Pro tocol Devi ation, Sit e Closure, and Study Closure R eports for the R&D c ommittee. | |
912 | 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 | |
913 | To retriev e an Exped ited Listi ng | |
914 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
915 | Closure Re ports in t he Safety committees . | |
916 | 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.9.5Hi ghAdminist rative Off icer, | |
917 | 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 StaffTo re trieve a L isting of studies du e continui ng review run for sp ecified pe riods in t he R&D, Sa fety, and IACUC comm ittees.A l isting of studies du e continui ng review can be run for speci fied perio ds showing R&D numbe r, study t itle, date due, date report re ceived, da te CR appr oved, and date CR re ported to Board for expedited review, if applicabl e. Also in cludes sub headings of sites f or each st udy listin g: site, L SI, date r eport rece ived, date approved, and date expedited review rep orted to R &D if appl icable in the R&D co mmittees. | |
918 | 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 . | |
919 | 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.To retrieve a Listing of studies due conti nuing revi ew run for specified periods. | |
920 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
921 | 9.6HighCom mittee Coo rdinator/ Committee Administra tor, R&D A dministrat or, R&D St aff, Safet y Administ rator, Saf ety Staff, IACUC Ad ministrato r, IACUC S taffTo ret rieve a Li sting of c losed proj ects and s ites in th e R&D, Saf ety, and I ACUC commi ttees.I ca n differen tiate betw een site s tudy closu re and mai n study cl osure in t he R&D app lication. | |
922 | I can diff erentiate between si te study c losure and main stud y closure in the Saf ety applic ation. | |
923 | I can diff erentiate between si te study c losure and main stud y closure in the IAC UC applica tion.I can different iate betwe en site st udy closur e and main study clo sure. | |
924 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.7Hig hCommittee Coordinat or/ Commit tee Admini strator, R &D Adminis trator, R& D Staff, S afety Admi nistrator, Safety St aff, IACU C Administ rator, IAC UC Staff | |
925 | To retriev e study Ac tion Repor ts in the R&D, Safet y and IACU C committe e applicat ion.A list ing of all pending o pen action s that can also be b roken down and run b y specific action su ch as pre- reviews, n ew studies , PI and L SI amendme nts, Local Site Appl ications, Updates, S AE/UAPs, P rotocol De viations, Updates in Progress, and Revie w of Audit and Closu re Reports R&D commi ttee appli cation. | |
926 | 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. | |
927 | 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.To re trieve stu dy Action Reports. | |
928 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.8Hig hAdministr ative Offi cer, | |
929 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ rator | |
930 | Review the Action Re ports in t he R&D, Sa fety, and IACUC comm ittee appl ication. | |
931 | 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. | |
932 | 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. | |
933 | 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.A l isting of all open a ctions by assigned V A Central IRB Manage r or Revie wer will i nclude stu dy status notes. | |
934 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure. | |
935 | 9.9HighAdm inistrativ e Officer, | |
936 | Associate Chief of S taff for R esearch, C ommittee C oordinator / Committe e Administ ratorTo re ceive an a nnual repo rt from ea ch committ ee member to the RDC (that inc ludes – | |
937 | Committee Review Sta tistics | |
938 | Committee Review Sta tistics- C ommittee M embers | |
939 | Committee Review Sta tistics – Events | |
940 | Committee Review Sta tistics – Initial Ap provals | |
941 | Committee Review Sta tistics – Reviewers for the R& D, safety, and IACUC committee s.I can re view ongoi ng activit ies of the R&D commi ttee. | |
942 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
943 | I can revi ew ongoing activitie s of the I ACUC commi ttee. | |
944 | I can revi ew ongoing activitie s of the c ommittee. | |
945 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.10Hi ghAdminist rative Off icer, | |
946 | 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 | |
947 | Receive an annual re port | |
948 | For Direct or’s Certi fication i ncluding t he followi ng details : | |
949 | Protocols searches | |
950 | Summary – Protocol C ounts by T ype/Status | |
951 | Summary – Active Pro tocols | |
952 | Protocol D etails by PI | |
953 | By Type (A nimal, Ani mal/Human, Human, Sc ience-Safe ty, Scienc e- only, A CORP) | |
954 | By Status (Active, P ending, Cl osed, Expi red, etc.) | |
955 | By Event T ype, Item Type | |
956 | in the R&D , Safety, and IACUC committees .I can rev iew ongoin g activiti es of the R&D commit tee. | |
957 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
958 | I can revi ew ongoing activitie s of the I ACUC commi ttee.I can review on going acti vities of the commit tee. | |
959 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.11Hi ghAdminist rative Off icer, | |
960 | Associate Chief of S taff for R esearchTo receive a report fro m each of the commit tees with the follow ing inform ation: (Co mmittee Ro sters, tra ining and appointmen t expirati on dates | |
961 | Initial ap proval dat es | |
962 | Continuing Reviews | |
963 | o Approval s – Expira tion Unkno wn [No CR Mths] | |
964 | o Approval s – Expire d | |
965 | o Approval s – Unexpi red [No CR Event] | |
966 | in the R&D , Safety, and IACUC committees .I can rev iew ongoin g activiti es of the R&D commit tee. | |
967 | I can revi ew ongoing activitie s of the S afety comm ittee. | |
968 | I can revi ew ongoing activitie s of the I ACUC commi ttee.I can review on going acti vities of the commit tee. | |
969 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.9.12Hi ghAdminist rative Off icer, | |
970 | 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 istratorTo research financial conflict o f interest in the R& D, Safety, and IACUC committee s.Financia l conflict of intere st can be managed in the R&D c ommittees. | |
971 | Financial conflict o f interest can be ma naged in t he Safety committees . | |
972 | Financial conflict o f interest can be ma naged in t he IACUC c ommittees. Financial conflict o f interest can be ma naged. | |
973 | This epics will need to be bui lt to acco mmodate ad ditional c ommittees in the fut ure.Graphi cal User I nterface ( GUI) Speci fications | |
974 | 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. | |
975 | Multi-Divi sional Spe cification s | |
976 | 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. | |
977 | Performanc e Specific ations | |
978 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
979 | 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. | |
980 | 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: | |
981 | ORD Centr al Office. | |
982 | Active fie ld researc h offices | |
983 | The implem ented tool will supp ort the ma jor busine ss functio ns of the: | |
984 | Local Rese arch Offic e | |
985 | Management of the Re search and Developme nt (R& D) Committee and its su bcommittee s (Institu tional Rev iew Board (IRB) | |
986 | Institutio nal Animal Care and Use Commit tee (IACUC ) | |
987 | Subcommitt ee on Rese arch Safet y (SRS) | |
988 | Local rese arch offic e reportin g to ORD | |
989 | 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. | |
990 | The follow ing table provides t he capacit y and perf ormance in formation for the RA MS Integra tion. | |
991 | Table 12: Capacity a nd Perform ance | |
992 | SLR Questi onSLR Crit eriaHow ma ny Users w ill be on the system hourly?10 1-1000 est imatedHow many trans actions wi ll each av erage User perform e ach hour?> 10 estimat edWhat are the antic ipated pea k User tim es during the day?Bu siness day (highest peak User times Mon. through F ri. during administr ative hour s)What is the antici pated peak transacti on load (w hen do you think tha t there wi ll be the most trans actions be ing perfor med on the system) d uring the day?Busine ss day (hi ghest peak User time s Mon. thr ough Fri. during adm inistrativ e hours)Ho w many new Users wil l be added in one ye ar?101-100 0 estimate dHow many more (if a ny) transa ctions wil l be added in one ye ar?>10 est imatedWhat kind of i nformation will be s tored? (Sp ecify aver age of eac h kind per month)Sma ll documen ts (exampl e pdf or W ord file) | |
993 | Forms & Do cuments th at are for matted (ex ample form s or docum ents with imagesWhat kind of s earch capa city is re quired?Med ium (11-10 00 per hou r) | |
994 | estimatedW hat type o f system(s ) is/are r equired?We b based an d managed from centr al service and datab ase | |
995 | Intranet ( All VA)Is there a ne ed for hea vy applica tion repor ting? If y es, when?E nd of day, End of mo nth, End o f quarterE xisting Pe rformance Specificat ion Requir ements | |
996 | 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. | |
997 | 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. | |
998 | 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 . | |
999 | 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. | |
1000 | 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. | |
1001 | RAMS shall process a nd use Coo rdinated U niversal T ime (UTC) for intern al and ext ernal time synchroni zation. | |
1002 | 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. | |
1003 | The data i n the RAMS datamart shall be r efreshed f rom the op erational database o nce a day. | |
1004 | RAMS Users shall hav e consiste nt respons e times wh en accessi ng RAMS ca pabilities during no rmal opera tion. | |
1005 | 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. | |
1006 | 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. | |
1007 | Quality At tributes S pecificati on | |
1008 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1009 | 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. | |
1010 | 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. | |
1011 | The follo wing types of testin g will be performed to assess the qualit y of the s olution: | |
1012 | Unit testi ng | |
1013 | Integratio n / functi onal testi ng | |
1014 | User Accep tance Test ing (UAT) | |
1015 | Section 50 8 testing | |
1016 | Performanc e testing | |
1017 | The RAMS I ntegration services will also consist of the follo wing quali ty specifi cations: | |
1018 | 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. | |
1019 | 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. | |
1020 | Additional ly, as pre viously de fined, the following quality s pecificati ons will b e adhered to: | |
1021 | 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. | |
1022 | 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. | |
1023 | Reliabilit y Specific ations | |
1024 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1025 | 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: | |
1026 | A quantita tive state ment of th e reliabil ity requir ement; | |
1027 | 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 ; | |
1028 | The time m easure or mission pr ofile; | |
1029 | A clear de finition o f what con stitutes f ailure; an d | |
1030 | 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 | |
1031 | 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. | |
1032 | Monitoring also prov ides capac ity trendi ng, allowi ng proacti ve system modificati ons or pla nning for upgrades. | |
1033 | 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 : | |
1034 | Stable and reliable performanc e | |
1035 | Availabili ty – The s ystem shal l be avail able 24 ho urs per da y and 7 da ys a week | |
1036 | Accurate d ata – The system sha ll return entries ex actly as t hey were p assed with no modifi cation. | |
1037 | 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. | |
1038 | 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 | |
1039 | Accessible informati on related to the so urce of da ta | |
1040 | 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. | |
1041 | The follow ing table lists the availabili ty of the RAMS Integ ration sys tem. | |
1042 | Table 13: Availabili ty | |
1043 | SLR Questi onSLR Crit eriaDescri ptionHow m uch time s hould the system be available (and how m uch down t ime is acc eptable du e to incid ent [unexp ected] out age)?99.9% (8.76 hou rs down ti me)Intenti onally lef t blank.Wh en should the system be availa ble (what will be th e core ope rating hou rs of the system)?8 a.m. to 8 p.m., EST, Mon. thro ugh Fri.Th e system s hall requi re no more than 24 h ours of ma intenance per month. Servicing and maint enance is expected t o occur du ring night s and week ends.What are the co re operati ng hours o f the RAMS Help Desk ?9 a.m. to 6 p.m., E ST, Mon. t hrough Fri .The respo nse time o f a troubl e ticket i s dependen t upon the severity of the tic ket. | |
1044 | How soon s hould the system ful ly recover from an o utage? (In cludes Mea n Time to Restore [M TRS])Disas ter Recove ry within 72 hoursIn tentionall y left bla nk.How muc h data wil l be resto red when o utage is r ecovered?1 00% (conti nuous back -up)Intent ionally le ft blank.W hat time p eriod shou ld be cons idered for maintenan ce periods ?After hou rs (these would be o ff peak ho urs approv ed by the Office of Research a nd Develop ment)Inten tionally l eft blank. In what st andard tim e zone wil l the syst em operate ?All time zonesInten tionally l eft blank. Scope Inte gration | |
1045 | 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. | |
1046 | 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 | |
1047 | 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: | |
1048 | Table 14: Security S pecificati ons – Mode rate Impac t Controls | |
1049 | Control Nu mberContro l NameMode rate Impac tVA Guidan ceAC-1ACCE SS CONTROL POLICY AN D PROCEDUR ESAC-1VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).AC-2A CCOUNT MAN AGEMENTAC- 2 (1) (2) (3) (4)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AC-3 ACCESS ENF ORCEMENTAC -3VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .AC-4INFOR MATION FLO W ENFORCEM ENTAC-4VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AC-5 SEPARATION OF DUTIES AC-5VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).AC-6LEA ST PRIVILE GEAC-6 (1) (2) (5) ( 9) (10)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AC-7 UNSUCCESSF UL LOGON A TTEMPTSAC- 7VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). AC-8SYSTEM USE NOTIF ICATIONAC- 8VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). AC-11SESSI ON LOCKAC- 11 (1)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).AC-12 SESSION TE RMINATIONA C-12VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).AC-14PE RMITTED AC TIONS WITH OUT IDENTI FICATION O R AUTHENTI CATIONAC-1 4VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). AC-17REMOT E ACCESSAC -17 (1) (2 ) (3) (4)V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).AC -18WIRELES S ACCESSAC -18 (1)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AC-1 9ACCESS CO NTROL FOR MOBILE DEV ICESAC-19 (5)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).AC-20USE OF EXTERN AL INFORMA TION SYSTE MSAC-20 (1 ) (2)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).AC-21I NFORMATION SHARINGAC -21VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).AC-22PUB LICLY ACCE SSIBLE CON TENTAC-22V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).AT -1SECURITY AWARENESS AND TRAIN ING POLICY AND PROCE DURESAT-1V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).AT -2SECURITY AWARENESS TRAININGA T-2 (2)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AT-3 ROLE-BASED SECURITY TRAININGAT -3VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .AT-4SECUR ITY TRAINI NG RECORDS AT-4VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).AU-1AUD IT AND ACC OUNTABILIT Y POLICY A ND PROCEDU RESAU-1VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AU-2 AUDIT EVEN TSAU-2 (3) 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).A U-3CONTENT OF AUDIT RECORDSAU- 3 (1)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).AU-4AU DIT STORAG E CAPACITY AU-4VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).AU-5RES PONSE TO A UDIT PROCE SSING FAIL URESAU-5VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).AU- 6AUDIT REV IEW, ANALY SIS, AND R EPORTINGAU -6 (1) (3) 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).A U-7AUDIT R EDUCTION A ND REPORT GENERATION AU-7 (1)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).AU- 8TIME STAM PSAU-8 (1) 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).A U-9PROTECT ION OF AUD IT INFORMA TIONAU-9 ( 4)VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .AU-11AUDI T RECORD R ETENTIONAU -11VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).AU-12AUD IT GENERAT IONAU-12VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).CA- 1SECURITY ASSESSMENT AND AUTHO RIZATION P OLICY AND PROCEDURES CA-1VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).CA-2SEC URITY ASSE SSMENTSCA- 2 (1)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).CA-3SY STEM INTER CONNECTION SCA-3 (5)V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).CA -5PLAN OF ACTION AND MILESTONE SCA-5VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).CA-6SE CURITY AUT HORIZATION CA-6VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).CA-7CON TINUOUS MO NITORINGCA -7 (1)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).CA-9I NTERNAL SY STEM CONNE CTIONSCA-9 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).C M-1CONFIGU RATION MAN AGEMENT PO LICY AND P ROCEDURESC M-1VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).CM-2BASE LINE CONFI GURATIONCM -2 (1) (3) (7)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).CM-3CON FIGURATION CHANGE CO NTROLCM-3 (2)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).CM-4SECU RITY IMPAC T ANALYSIS CM-4VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).CM-5ACC ESS RESTRI CTIONS FOR CHANGECM- 5VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). CM-6CONFIG URATION SE TTINGSCM-6 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).C M-7LEAST F UNCTIONALI TYCM-7 (1) (2) (4)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).CM- 8INFORMATI ON SYSTEM COMPONENT INVENTORYC M-8 (1) (3 ) (5)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).CM-9CO NFIGURATIO N MANAGEME NT PLANCM- 9VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). CM-10SOFTW ARE USAGE RESTRICTIO NSCM-10VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).CM-1 1USER-INST ALLED SOFT WARECM-11V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).CP -1CONTINGE NCY PLANNI NG POLICY AND PROCED URESCP-1VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).CP- 2CONTINGEN CY PLANCP- 2 (1) (3) (8)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).CP-3CONT INGENCY TR AININGCP-3 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).C P-4CONTING ENCY PLAN TESTINGCP- 4 (1)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).CP-6AL TERNATE ST ORAGE SITE CP-6 (1) ( 3)VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .CP-7ALTER NATE PROCE SSING SITE CP-7 (1) ( 2) (3)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).CP-8T ELECOMMUNI CATIONS SE RVICESCP-8 (1) (2)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).CP- 9INFORMATI ON SYSTEM BACKUPCP-9 (1)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).CP-10IN FORMATION SYSTEM REC OVERY AND RECONSTITU TIONCP-10 (2)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).IA-1IDEN TIFICATION AND AUTHE NTICATION POLICY AND PROCEDURE SIA-1VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).IA-2ID ENTIFICATI ON AND AUT HENTICATIO N (ORGANIZ ATIONAL US ERS)IA-2 ( 1) (2) (3) (8) (11) (12)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).IA-3DEV ICE IDENTI FICATION A ND AUTHENT ICATIONIA- 3VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). IA-4IDENTI FIER MANAG EMENTIA-4V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).IA -5AUTHENTI CATOR MANA GEMENTIA-5 (1) (2) ( 3) (11)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).IA-6 AUTHENTICA TOR FEEDBA CKIA-6VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).IA-7C RYPTOGRAPH IC MODULE AUTHENTICA TIONIA-7VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).IA- 8IDENTIFIC ATION AND AUTHENTICA TION (NON- ORGANIZATI ONAL USERS )IA-8 (1) (2) (3) (4 )VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). IR-1INCIDE NT RESPONS E POLICY A ND PROCEDU RESIR-1VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).IR-2 INCIDENT R ESPONSE TR AININGIR-2 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).I R-3INCIDEN T RESPONSE TESTINGIR -3 (2)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).IR-4I NCIDENT HA NDLINGIR-4 (1)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).IR-5INC IDENT MONI TORINGIR-5 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).I R-6INCIDEN T REPORTIN GIR-6 (1)V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).IR -7INCIDENT RESPONSE ASSISTANCE IR-7 (1)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).IR- 8INCIDENT RESPONSE P LANIR-8VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).MA-1 SYSTEM MAI NTENANCE P OLICY AND PROCEDURES MA-1VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).MA-2CON TROLLED MA INTENANCEM A-2VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).MA-3MAIN TENANCE TO OLSMA-3 (1 ) (2)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).MA-4NO NLOCAL MAI NTENANCEMA -4 (2)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).MA-5M AINTENANCE PERSONNEL MA-5VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).MA-6TIM ELY MAINTE NANCEMA-6V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).MP -1MEDIA PR OTECTION P OLICY AND PROCEDURES MP-1VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).MP-2MED IA ACCESSM P-2VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).MP-3MEDI A MARKINGM P-3VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).MP-4MEDI A STORAGEM P-4VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).MP-5MEDI A TRANSPOR TMP-5 (4)V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).MP -6MEDIA SA NITIZATION MP-6VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).MP-7MED IA USEMP-7 (1)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).PE-1PHY SICAL AND ENVIRONMEN TAL PROTEC TION POLIC Y AND PROC EDURESPE-1 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).P E-2PHYSICA L ACCESS A UTHORIZATI ONSPE-2VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).PE-3 PHYSICAL A CCESS CONT ROLPE-3VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).PE-4 ACCESS CON TROL FOR T RANSMISSIO N MEDIUMPE -4VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PE-5ACCES S CONTROL FOR OUTPUT DEVICESPE -5VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PE-6MONIT ORING PHYS ICAL ACCES SPE-6 (1)V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).PE -8VISITOR ACCESS REC ORDSPE-8VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).PE- 9POWER EQU IPMENT AND CABLINGPE -9VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PE-10EMER GENCY SHUT OFFPE-10VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).PE- 11EMERGENC Y POWERPE- 11VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PE-12EMER GENCY LIGH TINGPE-12V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).PE -13FIRE PR OTECTIONPE -13 (3)VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).PE-1 4TEMPERATU RE AND HUM IDITY CONT ROLSPE-14V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).PE -15WATER D AMAGE PROT ECTIONPE-1 5VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). PE-16DELIV ERY AND RE MOVALPE-16 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).P E-17ALTERN ATE WORK S ITEPE-17VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).PL- 1SECURITY PLANNING P OLICY AND PROCEDURES PL-1VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).PL-2SYS TEM SECURI TY PLANPL- 2 (3)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).PL-4RU LES OF BEH AVIORPL-4 (1)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).PL-8INFO RMATION SE CURITY ARC HITECTUREP L-8VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).PS-1PERS ONNEL SECU RITY POLIC Y AND PROC EDURESPS-1 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).P S-2POSITIO N RISK DES IGNATIONPS -2VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PS-3PERSO NNEL SCREE NINGPS-3VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).PS- 4PERSONNEL TERMINATI ONPS-4VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).PS-5P ERSONNEL T RANSFERPS- 5VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). PS-6ACCESS AGREEMENT SPS-6VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).PS-7TH IRD-PARTY PERSONNEL SECURITYPS -7VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .PS-8PERSO NNEL SANCT IONSPS-8VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).RA- 1RISK ASSE SSMENT POL ICY AND PR OCEDURESRA -1VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .RA-2SECUR ITY CATEGO RIZATIONRA -2VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .RA-3RISK ASSESSMENT RA-3VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).RA-5VUL NERABILITY SCANNINGR A-5 (1) (2 ) (5)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).SA-1SY STEM AND S ERVICES AC QUISITION POLICY AND PROCEDURE SSA-1VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).SA-2AL LOCATION O F RESOURCE SSA-2VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).SA-3SY STEM DEVEL OPMENT LIF E CYCLESA- 3VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). SA-4ACQUIS ITION PROC ESSSA-4 (1 ) (2) (9) (10)VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).SA-5INF ORMATION S YSTEM DOCU MENTATIONS A-5VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).SA-8SECU RITY ENGIN EERING PRI NCIPLESSA- 8VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). SA-9EXTERN AL INFORMA TION SYSTE M SERVICES SA-9 (2)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).SA- 10DEVELOPE R CONFIGUR ATION MANA GEMENTSA-1 0VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). SA-11DEVEL OPER SECUR ITY TESTIN G AND EVAL UATIONSA-1 1VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). SC-1SYSTEM AND COMMU NICATIONS PROTECTION POLICY AN D PROCEDUR ESSC-1VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SC-2A PPLICATION PARTITION INGSC-2VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).SC-4 INFORMATIO N IN SHARE D RESOURCE SSC-4VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).SC-5DE NIAL OF SE RVICE PROT ECTIONSC-5 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).S C-7BOUNDAR Y PROTECTI ONSC-7 (3) (4) (5) ( 7)VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .SC-8TRANS MISSION CO NFIDENTIAL ITY AND IN TEGRITYSC- 8 (1)VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).SC-10N ETWORK DIS CONNECTSC- 10VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .SC-12CRYP TOGRAPHIC KEY ESTABL ISHMENT AN D MANAGEME NTSC-12VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).SC-1 3CRYPTOGRA PHIC PROTE CTIONSC-13 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).S C-15COLLAB ORATIVE CO MPUTING DE VICESSC-15 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).S C-17PUBLIC KEY INFRA STRUCTURE CERTIFICAT ESSC-17VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).SC-1 8MOBILE CO DESC-18VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).SC-1 9VOICE OVE R INTERNET PROTOCOLS C-19VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).SC-20SE CURE NAME / ADDRESS RESOLUTION SERVICE ( AUTHORITAT IVE SOURCE )SC-20VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SC-21 SECURE NAM E / ADDRES S RESOLUTI ON SERVICE (RECURSIV E OR CACHI NG RESOLVE R)SC-21VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).SC-2 2ARCHITECT URE AND PR OVISIONING FOR NAME / ADDRESS RESOLUTION SERVICESC -22VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).SC-23SES SION AUTHE NTICITYSC- 23VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .SC-28PROT ECTION OF INFORMATIO N AT RESTS C-28VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).SC-39PR OCESS ISOL ATIONSC-39 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).S I-1SYSTEM AND INFORM ATION INTE GRITY POLI CY AND PRO CEDURESSI- 1VA Direct ive 6500, VA Handboo k 6500, Ma rch 2015, Appendix C : (Referen ces), Appe ndix E: (V A System P rivacy Con trols), Ap pendix F: (VA System Security Controls). SI-2FLAW R EMEDIATION SI-2 (2)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).SI- 3MALICIOUS CODE PROT ECTIONSI-3 (1) (2)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).SI- 4INFORMATI ON SYSTEM MONITORING SI-4 (2) ( 4) (5)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SI-5S ECURITY AL ERTS, ADVI SORIES, AN D DIRECTIV ESSI-5VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SI-7S OFTWARE, F IRMWARE, A ND INFORMA TION INTEG RITYSI-7 ( 1) (7)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SI-8S PAM PROTEC TIONSI-8 ( 1) (2)VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SI-10 INFORMATIO N INPUT VA LIDATIONSI -10VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).SI-11ERR OR HANDLIN GSI-11VA D irective 6 500, VA Ha ndbook 650 0, March 2 015, Appen dix C: (Re ferences), Appendix E: (VA Sys tem Privac y Controls ), Appendi x F: (VA S ystem Secu rity Contr ols).SI-12 INFORMATIO N HANDLING AND RETEN TIONSI-12V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).SI -16MEMORY PROTECTION SI-16VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).Table 15: Securi ty Specifi cations - Privacy Co ntrols | |
1050 | Control | |
1051 | IDPrivacy Control Na meVA Guida nceAP Auth ority and Purpose VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).AP- 1 Authori ty to Coll ect VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).AP-2 Pu rpose Spec ification 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).A R Accounta bility, Au dit, and R isk Manage ment VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).AR-1 G overnance and Privac y Program 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).A R-2 Privac y Impact a nd Risk As sessment V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).AR -3 Privac y Requirem ents for C ontractors and Servi ce Provide rs VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).AR-4 Pr ivacy Moni toring and Auditing 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).A R-5 Privac y Awarenes s and Trai ning VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).AR-6 P rivacy Rep orting VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).AR-7 Privacy-E nhanced Sy stem Desig n and Deve lopment VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).AR- 8 Accounti ng of Disc losures VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).DI Data Quali ty and Int egrity VA Directive 6500, VA H andbook 65 00, March 2015, Appe ndix C: (R eferences) , Appendix E: (VA Sy stem Priva cy Control s), Append ix F: (VA System Sec urity Cont rols).DI-1 Data Qual ity VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).DI-2 Da ta Integri ty and Dat a Integrit y Board VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).DM Data Minim ization an d Retentio n VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .DM-1 Mini mization o f Personal Identific ation Info rmation (P II)VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).DM-2 Dat a Retentio n and Disp osal VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).DM-3 M inimizatio n of PII u sed in Tes ting, Trai ning, and Research V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).IP Individua l Particip ation and Redress VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).IP- 1 Consent 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).I P-2 Indivi dual Acces s VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .IP-3 Redr ess VA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).IP-4 Co mplaint Ma nagement V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).SE Security 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).S E-1 Invent ory of Per sonal Iden tification Informati on (PII)VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).SE- 2 Privacy Incident R esponse VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).TR Transparen cy VA Dire ctive 6500 , VA Handb ook 6500, March 2015 , Appendix C: (Refer ences), Ap pendix E: (VA System Privacy C ontrols), Appendix F : (VA Syst em Securit y Controls ).TR-1 Pri vacy Notic e VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .TR-2 Syst em of Reco rds Notice s and Priv acy Act St atements V A Directiv e 6500, VA Handbook 6500, Marc h 2015, Ap pendix C: (Reference s), Append ix E: (VA System Pri vacy Contr ols), Appe ndix F: (V A System S ecurity Co ntrols).TR -3 Dissemi nation of Privacy Pr ogram Info rmation VA Directive 6500, VA Handbook 6 500, March 2015, App endix C: ( References ), Appendi x E: (VA S ystem Priv acy Contro ls), Appen dix F: (VA System Se curity Con trols).UL Use Limita tion VA Di rective 65 00, VA Han dbook 6500 , March 20 15, Append ix C: (Ref erences), Appendix E : (VA Syst em Privacy Controls) , Appendix F: (VA Sy stem Secur ity Contro ls).UL-1 I nternal Us e VA Direc tive 6500, VA Handbo ok 6500, M arch 2015, Appendix C: (Refere nces), App endix E: ( VA System Privacy Co ntrols), A ppendix F: (VA Syste m Security Controls) .UL-2 Info rmation Sh aring with Third Par tiesVA Dir ective 650 0, VA Hand book 6500, March 201 5, Appendi x C: (Refe rences), A ppendix E: (VA Syste m Privacy Controls), Appendix F: (VA Sys tem Securi ty Control s).System Features | |
1052 | 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. | |
1053 | Usability Specificat ions | |
1054 | The requir ements lis ted in thi s section are the sa me as exis ting RAMS requiremen ts. | |
1055 | Usability specificat ion requir ements are as outlin ed below: | |
1056 | Table 16: Usability Specificat ion Requir ements | |
1057 | Req. ID Re quirement Priority ( P1, P2, P3 ) Incremen t (1, 2, F uture) USA -001 RAMS shall foll ow the Gov ernment Us ability pr ocess as s pecified i n the usab ility.gov website ht tp://usabi lity.gov/m ethods/pro cess.html TBD1, 2USA -002RAMS s hall follo w the usab ility test ing as spe cified in the usabil ity.gov we bsite http ://usabili ty.gov/pdf s/chapter1 8.pdf TBD1 , 2USA-003 RAMS shall follow a User-cente red design (UCD) TBD 1, 2User E xperience encompasse s direct a nd indirec t interact ions betwe en the Use r and the system. Im proving us ability ov er the pri or version is a key requiremen t for this applicati on. The In ternationa l Organiza tion for S tandardiza tion (ISO) defines u sability a s “the ext ent to whi ch a produ ct can be used by sp ecified Us ers to ach ieve speci fied goals with effe ctiveness, efficienc y, and sat isfaction in a speci fied conte xt of use” (1998). | |
1058 | 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 . | |
1059 | In order t o improve usability of VA-deve loped or p urchased a pplication s, the fol lowing act ions are r equired: | |
1060 | • | |
1061 | 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 . | |
1062 | • | |
1063 | 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. | |
1064 | • | |
1065 | 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. | |
1066 | A sound UC D and deve lopment pr ocess base d on human factors s hould incl ude the fo llowing ac tivities: | |
1067 | • | |
1068 | Understand ing of the Users, th e Users’ t asks, and the Users’ environme nts | |
1069 | • | |
1070 | Review of similar or competiti ve systems to inform requireme nts and de sign | |
1071 | • | |
1072 | Heuristic evaluation of prior versions, prototypes , or basel ine applic ations, if applicabl e | |
1073 | • | |
1074 | 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) | |
1075 | • | |
1076 | User risk analysis | |
1077 | • | |
1078 | 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. ) | |
1079 | To demonst rate high usability, the appli cation sho uld be: | |
1080 | Intuitive and easy t o learn, w ith minima l training ; | |
1081 | Effective by allowin g Users to successfu lly comple te tasks; | |
1082 | Efficient by allowin g Users to complete their work in a mann er consist ent with c linical pr actice and workflow; | |
1083 | Perceived to have hi gh usabili ty, as dem onstrated by appropr iate surve y measures ; and | |
1084 | Designed t o aid User s in meeti ng task go als withou t being an additiona l burden. | |
1085 | The system must be r eliable an d enable U ser trust by providi ng: | |
1086 | • | |
1087 | Stable and reliable performanc e; | |
1088 | • | |
1089 | Accurate d ata; | |
1090 | • | |
1091 | 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 | |
1092 | • | |
1093 | Accessible informati on related to the so urce of da ta. | |
1094 | 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: | |
1095 | • | |
1096 | Integrated display o f structur ed and uns tructured data; | |
1097 | • | |
1098 | Rich data visualizat ion and gr aphical di splay of d ata; | |
1099 | • | |
1100 | Ability to switch be tween tabu lar and gr aphical da ta views; | |
1101 | • | |
1102 | Ability to interact with displ ayed data to obtain additional details r elated to the data a nd source of the dat a; and | |
1103 | • | |
1104 | User custo mizable co mponents a nd setting s. | |
1105 | The applic ation must provide f or advance d and up-t o-date sea rching, to include: | |
1106 | • | |
1107 | Fast searc h function ality with auto-comp lete and r eal-time d isplay of matched re sults duri ng typing; and | |
1108 | • | |
1109 | Search his tory. | |
1110 | The applic ation must provide f or advance d filterin g capabili ties, to i nclude: | |
1111 | • | |
1112 | Filtering of data ta bles, list s, and gri ds; and | |
1113 | • | |
1114 | Filtering of search results. | |
1115 | The applic ation desi gn should be modifie d to: | |
1116 | • | |
1117 | Address th e specific findings from a hum an factor heuristic evaluation conducted on the pr ior versio n of the a pplication ; | |
1118 | • | |
1119 | Address th e specific findings reported f rom field use of the prior ver sion; and | |
1120 | • | |
1121 | Address th e specific findings reported f rom usabil ity testin g of the p rior versi on or rele vant proto types. | |
1122 | The follow ing table outlines t he usabili ty/User in terface re quirements for the R AMS Integr ation. | |
1123 | Table 17: Usability/ User Inter face Requi rements | |
1124 | Identifier Usability/ User Inter face Requi rementsNo identifier provided in BRD.Lef t align co ntent in t able cells to facili tate quick visual sc an.No iden tifier pro vided in B RD.Left al ign text f or column headers to facilitat e visual s can and ma ke columns and conte nt appear more organ ized.No id entifier p rovided in BRD.Use m ixed case instead of all caps whenever p ossible (e .g., dropd own list i tems, tabl e data, ta ble header s, hyperli nks, tab n ames). Lim it the use of “all c aps” throu ghout the applicatio n.No ident ifier prov ided in BR D.Simplify button la bels. Re-l abel butto ns to refl ect standa rd termino logy that is common in web int erfaces an d other ap plications (e.g., “C ancel”). E mphasize t he action being perf ormed in t he most su ccinct way possible. Minimize redundancy in text/t erminology that is u sed to con vey the sa me action. No identif ier provid ed in BRD. Left align page/sect ion titles to anchor titles in consisten t location s regardle ss of wind ow sizing. No identif ier provid ed in BRD. 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. No identif ier provid ed in BRD. 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.No identifier provided in BRD.Use colors su ch as red and green only for s tatus driv en content . Avoid us ing red fo r text/con tent, link s, button labels, et c. This wi ll reduce risk for U ser error, improve l ink discov erability, and facil itate unde rstanding of differe nces in na vigation/a ctions/con tent. It w ill also h elp Users to isolate important status in formation (using red , green, e tc.) from other less important informati on when vi ewing and processing informati on provide d to them on a page. No identif ier provid ed in BRD. Provide vi sual separ ation betw een the na vigation s pace and t he main co ntent area .No identi fier provi ded in BRD .Add field level val idation an d notifica tion of mi ssing info rmation on the same page witho ut launchi ng a new w indow or n avigating to another page.No i dentifier provided i n BRD.Make all text hyperlinks appear co nsistent i n style.No identifie r provided in BRD.Ma ke drop-do wn selecti on box wid ths approp riate for content an d visual a ppeal.No i dentifier provided i n BRD.Use standard a nd always visible ra dio button s for “Yes /No” optio ns instead of requir ing the Us er to clic k in a dro p down box and then click to s elect the “Yes” or “ No” option .No identi fier provi ded in BRD .Use stand ard date a nd time se lection wi dgets. Whe re date an d time are selected/ picked fro m a standa rd widget, also prov ide direct data entr y to suppo rt keyboar d navigati on. Enable field lev el validat ion immedi ately upon entry. In clude inst ructional format tex t within t he field e ntry box.N o identifi er provide d in BRD.P rovide sta ndard sort behavior and visual indicatio ns on colu mns in all tables.No identifie r provided in BRD.De fine and a dhere to a standard model for use and de sign of co ntrols, bu ttons, hyp erlinks, a nd navigat ion elemen ts.No iden tifier pro vided in B RD.Ensure that text is sized t o be reada ble (for e xample, by using the 007 Rule to assure text size is readabl e for User s with 20/ 40 vision. The formu la: Text h eight = .0 07 * dista nce betwee n eyes and screen).N o identifi er provide d in BRD.P lace commo n navigati on element s in consi stent loca tions.No i dentifier provided i n BRD.Plac e critical informati on “above the fold” (i.e., in the top po rtion of t he screen that is im mediately viewable). No identif ier provid ed in BRD. Use consis tent scree n flow mod els, eleme nts, and t erms to su pport simi lar workfl ows.No ide ntifier pr ovided in BRD.Use co nsistently named but tons when actions ar e the same (e.g., Ad d, vs. Sav e, vs. Sub mit).No id entifier p rovided in BRD.Enabl e Users to print vie ws from wh ere they a re in the interface. Avoid req uiring the User to “ run a repo rt” in ord er to prin t somethin g that is viewable o n the scre en.No iden tifier pro vided in B RD.Provide field ent ry tool ti ps at the field loca tion. Ensu re consist ency acros s the appl ication in field lab els, forma ts, locati on of tool tips, and tool tip text.No id entifier p rovided in BRD.Provi de visual indication of requir ed fields. No identif ier provid ed in BRD. Display fi eld labels in close proximity to entry e lements.No identifie r provided in BRD.Us e consiste nt element s to filte r data.No identifier provided in BRD.Use consisten t elements to sort d ata.No ide ntifier pr ovided in BRD.Use a consistent model for display, layout, an d grouping of data e ntry field s.No ident ifier prov ided in BR D.Provide alternate row shadin g in lengt hy tables of data, f orm elemen ts, etc.No identifie r provided in BRD.En sure that icons are recognized by Users. No identif ier provid ed in BRD. Provide so me “white space” bet ween statu s icons in report vi ews, white board vie ws, etc.No identifie r provided in BRD.Au to-populat e default values in entry/sele ction fiel ds when po ssible and appropria te.No iden tifier pro vided in B RD.Visuall y differen tiate stat us icons f rom clicka ble icons, when appr opriate.No identifie r provided in BRD.De fine and s upport the appropria te User ta b sequence through f ields in f orms in or der to sup port keybo ard naviga tion when entering d ata in for ms.No iden tifier pro vided in B RD.Define and adhere to standa rd action button pla cement on screens, f orms, etc. No identif ier provid ed in BRD. Visually d istinguish the prima ry action button on a page.No identifier provided in BRD.Con sistently use screen elements, action el ements, wo rkflow seq uences wit hin/across screens, language, etc.No ide ntifier pr ovided in BRD.Provid e error me ssages in User-centr ic languag e with spe cific inst ructions o n the mean ing of the error and how to re cover from it. Use e rror messa ges and me thod of di splay cons istently a cross the interface. No identif ier provid ed in BRD. Provide co ntext-spec ific Help. No identif ier provid ed in BRD. Do not use the term “sex” or a ny like ab breviation s to repre sent gende r.Purchase d Componen ts | |
1125 | 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. | |
1126 | Estimation | |
1127 | 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
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|
1128 | The name o f the proj ect as it appears in the Proje ct Managem ent Accoun tability S ystem (PMA S) | |
1129 | The increm ent Number and Type (delivery, IOC, depl oyment, vi sibility, and monito ring) | |
1130 | The correc t Enterpri se Project Structure (EPS) num ber | |
1131 | The date o f MS1 revi ew | |
1132 | 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.) | |
1133 | Project So ftware Fun ctional Si ze and Siz e-Based Ef fort and D uration Es timate | |
1134 | Applicatio n | |
1135 | ItemABCDET otalCounte d Function PointsEst imated Sco pe GrowthE stimated S ize at Rel easeSize-B ased Effor t Estimate sLabor Hou rs Probabi lityLow-Ef fort Estim ate – With indicated probabili ty, projec t will con sume no mo re than: H igh-Effort Estimate – With ind icated pro bability, project wi ll consume no more t han:Size-B ased Durat ion Estima tesWork Da ysProbabil ityLow-Dur ation Esti mate – Wit h indicate d probabil ity, proje ct will co nsume no m ore than: High-Durat ion Estima te -- With indicated probabili ty, projec t will con sume no mo re than:Fi gure 1: Cu mulative P robability (“S-curve ”) Chart | |
1136 | [Insert Cu mulative P robability (“S-curve ”) Charts here] | |
1137 | Approval S ignatures | |
1138 | REVIEW DAT E: Februar y 5, 2016 | |
1139 | SCRIBE: Pa ul Bockewi tz | |
1140 | Signed: | |
1141 | __________ __________ __________ __________ __________ __________ __________ ________ | |
1142 | Glenda Mil ler, Integ rated Proj ect Team ( IPT) Chair | |
1143 | Date | |
1144 | __________ __________ __________ __________ __________ __________ __________ ________ | |
1145 | James Bree ling, M.D. , Business Sponsor | |
1146 | Date | |
1147 | __________ __________ __________ __________ __________ __________ __________ ________Ma risue Cody , Ph.D., B usiness Ow ner | |
1148 | Date | |
1149 | __________ __________ __________ __________ __________ __________ __________ ________To by Rudik, IT Program Manager | |
1150 | Date | |
1151 | __________ __________ __________ __________ __________ __________ __________ ________ | |
1152 | Glenda Mil ler, Proje ct Manager | |
1153 | Date | |
1154 | Appendix A : Non-Func tional Req uirements | |
1155 | 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. | |
1156 | System Per formance R eporting R equirement s | |
1157 | 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. | |
1158 | 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. | |
1159 | 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. | |
1160 | 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. | |
1161 | Listed bel ow is Busi ness Need 6, The Cen tral Offic e Reportin g Requirem ents: | |
1162 | Table 18: Reporting Requiremen ts | |
1163 | BN6Central Office Re porting Re quirements Priority6. 1Create re al-time ex penditure reports.Me dium prior ity6.2Prov ide query and report ing tools for | |
1164 | administra tive resea rch data.H igh priori ty6.3Defin e portfoli o reportin g categori es of fund ed researc h projects , with too ls for adm inistrate research d ata.Comple ted in an alternativ e project6 .4Support 200+ pre-d efined cat egories fr om the | |
1165 | NIH.Comple ted in an alternativ e | |
1166 | project6.5 Support VA -specific portfolio categories .Completed in an alt ernative | |
1167 | project6.6 Ability to individua lly re-wei ght concep ts in any category t o meet exp ectationsC ompleted i n an alter native | |
1168 | project6.7 Screen inc oming prop osals agai nst simila r applicat ions in ex isting por tfolios of VA, NIH, and other funding in stitutions .Completed in an alt ernative p roject6.8G enerate in ternal and external reviewer p rofiles ba sed on pub lished res earch data Completed in an alte rnative | |
1169 | project6.9 Ability to categoriz e internal and exter nal review er profile s based on known con cepts.Comp leted in a n alternat ive | |
1170 | project6.1 0Automatic detection of confli cts of int erest betw een incomi ng proposa l and revi ewer profi les.Comple ted in an alternativ e | |
1171 | project6.1 1Ability t o compare incoming p roposals t o internal and exter nal review er profile s.Complete d in an al ternative project6.1 2Export ra w data in XML which can be ana lyzed with third-par ty busines s intellig ence, anal ysis and v isualizati on tools.H igh priori tyOperatio nal Enviro nment Requ irements | |
1172 | System res ponse time s and page load time s shall be consisten t with PIT C Enterpri se standar ds. | |
1173 | 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. | |
1174 | 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. | |
1175 | Provide a real-time monitoring solution to report agreed/ide ntified cr itical sys tem perfor mance para meters. | |
1176 | 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. | |
1177 | 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. | |
1178 | Documentat ion Requir ements | |
1179 | 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. | |
1180 | 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. | |
1181 | 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. | |
1182 | 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 . | |
1183 | 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. | |
1184 | Implementa tion Requi rements | |
1185 | 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. | |
1186 | The follow ing is a l ist of Imp lementatio n Requirem ents | |
1187 | There is a need to t rain the t argeted st aff groups on the ne w function ality. | |
1188 | 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. | |
1189 | 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. | |
1190 | Data Prote ction/Back -up/Archiv e Requirem ents | |
1191 | 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. | |
1192 | 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 ). | |
1193 | 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. | |
1194 | Levels for Disaster Recovery | |
1195 | Classifica tion | |
1196 | Recovery T ime Object ive | |
1197 | Recovery P oint | |
1198 | Objective Routine | |
1199 | 30 day res toration | |
1200 | TBD | |
1201 | Mission Es sential | |
1202 | 72 hour re storation | |
1203 | 24 hours | |
1204 | Mission Cr itical | |
1205 | 12 hour re storation | |
1206 | 2 hours | |
1207 | 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. | |
1208 | 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. | |
1209 | 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 . | |
1210 | Table 19: Data Prote ction Requ irements | |
1211 | SLR Questi onSLR Crit eriaHow mu ch time sh ould the s ystem be a vailable ( and how mu ch down ti me is acce ptable due to incide nt [unexpe cted] outa ge)?99.9% (8.76 hour s down tim e)When sho uld the sy stem be av ailable (w hat will b e the core operating hours of the system )?8 a.m. t o 8 p.m., EST, Mon. through | |
1212 | Fri.How so on should the system fully rec over from an outage? (Includes Mean Time to Restor e [MTRS])D isaster Re covery wit hin 72 hou rsHow much data will be restor ed when ou tage is re covered?10 0% (contin uous back- up)What ti me period should be considered for maint enance per iods?After hours (th ese would be off pea k hours ap proved by the Office of Resear ch and Dev elopment)W hat standa rd time zo ne will th e system o perate in? All time z onesData Q uality/Ass urance Req uirements | |
1213 | 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. | |
1214 | User Acces s/Security Requireme nts | |
1215 | 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). | |
1216 | Table 20: User Acces s/Security Requireme nts | |
1217 | User Level RoleRespon sibilities RAMS Acces s LevelAdm inistrativ e OfficerS enior ORD official a t each res earch stat ionAdminis trative fu nctions of the resea rch progra m - | |
1218 | All commit tees Read/ WriteAssoc iate Chief of Staff for Resear chChief Op erational Officer fo r the rese arch stati onOversees committee s and subc ommittees and respon sible for coordinati on with au dit agenci es, as wel l as day t o day mana gement of the resear ch program at facili ties with large acti ve program s - All c ommitteesR ead/WriteC ommittee C oordinator / Committe e Administ ratorManag es all act ivities of the commi tteeCommun ication wi th Princip le Investi gators, as signment o f projects to agenda s, minutes , coordina tor of rev iewer comm ents, sche duling mee tings, tra cking comm ittee memb ers, and q uorums - A ll committ ees | |
1219 | TBDPrincip al Investi gator Dire cts resear ch project or progra mOversees scientific , technica l, and day -to-day ma nagement o f the rese arch and i s leader o f research team - Al l committe esRead/Wri tePrincipa l Investig ator Desig neeAssists in prepar ation of p roject/pro tocolCompl etes entry of compon ents assoc iated with the proto col, submi ts to IRB - All comm itteesTBDC o-Principa l Investig atorSimila r to Princ ipal Inves tigatorEns ures proje ct is cond ucted in c ompliance with appli cable laws and regul ations and instituti onal polic y - All co mmitteesRe ad/WriteIR B Administ ratorCondu cts review process f or conside rationsRev iews for i ssues, suc h as confl icts of in terest, in itial revi ew of disc losure for ms, determ ines wheth er referra ls are nee ded to spe cific comm ittees - A ll committ eesTBDIRB ChairDeter mines if a n applicat ion is com pleteDeter mines if a pplication lacks any disqualif ying featu res and fo rwards all applicati on materia ls to memb ers of IRB Committee - All com mitteesTBD IRB Member A member o f IRBMembe r of an el ected boar d or other group for mally desi gnated by an institu tion to re view, appr ove, requi re modific ation in, disapprove , and cond uct contin uing overs ight of hu man resear ch in acco rdance wit h laws and regulatio ns - All c ommitteesT BDIRB Staf fAssists t he Adminis trative Of ficer, IRB Chair in administra tive funct ionsPerfor ms adminis trative fu nctions. - All commi tteesTBDLo cal Site I nvestigato r (CIRB Ro le Only)In vestigator at site p articipati ng in a mu lti-site r esearch st udyOversee s scientif ic, techni cal, and d ay-to-day management of the re search at a local si teTBDLocal RAMS Admi nistratorU ser with s pecial pri vileges to establish and maint ain local User accou ntsAdminis trative fu nctions - All commit teesRead/W riteStudy Coordinato rSpecializ ed researc h coordina tor workin g under di rection of the Princ iple Inves tigatorFac ilitates t he daily t rial activ ities and conduct of the study , reports with admin istrative, scientifi c proposal preparati on and rev iew, budge t, award a cceptance, etc. - Al l committe esTBDORD A dministrat orDetermin es whether or not a given proj ect is a c andidate f or review by the VA Central IR BAdministr ative VA C entral IRB support.T BDUsabilit y/User Int erface Req uirements | |
1220 | 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. | |
1221 | Conceptual Integrity | |
1222 | The system shall pro vide stand ards-based messaging and middl eware infr astructure needed to support R AMS deploy ment. | |
1223 | Availabili ty | |
1224 | 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. | |
1225 | 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). | |
1226 | 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%. | |
1227 | 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. | |
1228 | Table 21: Availabili ty | |
1229 | SLR Questi onSLR Crit eriaHow mu ch time sh ould the s ystem be a vailable ( and how mu ch down ti me is acce ptable due to incide nt [unexpe cted] outa ge)?99.9% (8.76 hour s down tim e)When sho uld the sy stem be av ailable (w hat will b e the core operating hours of the system )?8 a.m. t o 8 p.m., EST, Mon. through | |
1230 | Fri.How so on should the system fully rec over from an outage? (Includes Mean Time to Restor e [MTRS])D isaster Re covery wit hin 72 hou rsHow much data will be restor ed when ou tage is re covered?10 0% (contin uous back- up)What ti me period should be considered for maint enance per iods?After hours (th ese would be off-pea k hours ap proved by the Office of Resear ch and Dev elopment)I n what sta ndard time zone will the syste m operate? All time z onesTable 22: Goal/O bjective | |
1231 | Goal/Objec tiveDesire d OutcomeM easurement ImpactProv ide a cent ralized en terprise-l evel repos itory of n ational VA research office pro gram data. 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.The cen tralized d ata reposi tory is av ailable by web conne ction to a ll VA rese arch offic es and sta keholders located at Central O ffice.The centralize d data rep ository su pports the internal exchange o f informat ion within the VA re search env ironment a nd communi cation of data with stakeholde rs in the research c ommunity.I nteroperab ility | |
1232 | 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. | |
1233 | 1. | |
1234 | The system shall sup port all r ecognized health sys tem standa rds | |
1235 | 2. | |
1236 | Systems mu st be hete rogeneous and agnost ic for ope rating sys tems and c ode bases. | |
1237 | 3. | |
1238 | Provide th e ability to securel y transfer large fil es (of 4-8 gigabytes ) from an external s ource to V A systems. | |
1239 | 4. | |
1240 | Provide ac cess to th e system o ver a remo te access solution. | |
1241 | Manageabil ity | |
1242 | 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. | |
1243 | Provide da ta-related to mainte nance even ts, both r outine and exception al, includ ing key me tadata: | |
1244 | Predicted routine wo rk | |
1245 | Occurrence s where ma intenance is complet ed, includ ing restar t from dow n time | |
1246 | Identity o f the orga nization p erforming maintenanc e | |
1247 | User perfo rming main tenance (i f availabl e) | |
1248 | Identity o f the syst em | |
1249 | Date/time, physical location | |
1250 | Systems im pacted | |
1251 | Whether it affects p atient car e | |
1252 | Non-urgent or emerge nt | |
1253 | 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. | |
1254 | 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 ). | |
1255 | Performanc e | |
1256 | 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. | |
1257 | 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: | |
1258 | ORD Centra l Office. | |
1259 | Active fie ld researc h offices | |
1260 | The implem ented tool will supp ort the ma jor busine ss functio ns of the: | |
1261 | Local rese arch offic e | |
1262 | Management of the Re search and Developme nt (R& D) Committee and its su bcommittee s (Institu tional Rev iew Board [IRB]) | |
1263 | Institutio nal Animal Care and Use Commit tee (IACUC ) | |
1264 | Subcommitt ee on Rese arch Safet y (SRS), | |
1265 | local rese arch offic e reportin g to ORD | |
1266 | 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. | |
1267 | Table 23: Performanc e | |
1268 | SLR Questi onSLR Crit eriaHow ma ny Users w ill be on the system hourly?10 1-1000 est imatedHow many trans actions wi ll each av erage User perform e ach hour?> 10 estimat edWhat are the antic ipated pea k User tim es during the day?Bu siness day (highest peak User times Mon. through F ri. during administr ative hour s)What is the antici pated peak transacti on load (w hen do you think tha t there wi ll be the most trans actions be ing perfor med on the system) d uring the day?Busine ss day (hi ghest peak User time s Mon thro ugh Fri du ring admin istrative hours)How many new U sers will be added i n one year ?101-1000 estimatedH ow many mo re (if any ) transact ions will be added i n one year ?>10 estim atedWhat k ind of inf ormation w ill be sto red? (Spec ify averag e of each kind per m onth)Small documents (example PDF or Wor d file) | |
1269 | Forms & Do cuments th at are for matted (ex ample form s or docum ents with images)Wha t kind of search cap acity is r equired?Me dium (11-1 000 per ho ur) | |
1270 | estimatedW hat type o f system(s ) is/are r equired?We b-based an d managed from centr al service and datab ase | |
1271 | Intranet ( All VA)Is there a ne ed for hea vy applica tion repor ting? If y es, when?E nd of day, End of mo nth, End o f quarterR eliability | |
1272 | 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: | |
1273 | Stable and reliable performanc e | |
1274 | Availabili ty – the s ystem shal l be avail able 8 a.m . to 8 p.m ., EST, Mo n. through Fri. | |
1275 | Accurate d ata - The system sha ll return entries ex actly as t hey were p assed, wit h no modif ication | |
1276 | 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 | |
1277 | Display of all data that is av ailable in native or interface d systems, and inten ded to be available in the app lication | |
1278 | Accessible informati on related to the so urce of da ta | |
1279 | 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. | |
1280 | Table 24: Reliabilit y | |
1281 | SLR Questi onSLR Crit eriaDescri ptionHow m uch time s hould the system be available (and how m uch down t ime is acc eptable du e to incid ent [unexp ected] out age)?99.9% (8.76 hou rs down ti me)Intenti onally lef t blank.Wh en should the system be availa ble (what will be th e core ope rating hou rs of the system)?8 a.m. to 8 p.m., EST, Mon. thro ugh | |
1282 | Fri.The sy stem shall require n o more tha n 24 hours of mainte nance per month. Ser vicing and maintenan ce is expe cted to oc cur during nights an d weekends .How soon should the system fu lly recove r from an outage? (I ncludes Me an Time to Restore [ MTRS])Disa ster Recov ery within 72 hoursI ntentional ly left bl ank.How mu ch data wi ll be rest ored when outage is recovered? 100% (cont inuous bac k-up)Inten tionally l eft blank. What time period sho uld be con sidered fo r maintena nce period s?After ho urs (these would be off peak h ours appro ved by the Office of Research and Develo pment)Inte ntionally left blank .In what s tandard ti me zone wi ll the sys tem operat e?All time zonesInte ntionally left blank .Security | |
1283 | 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. | |
1284 | Supportabi lity | |
1285 | The follow ing table lists the priority l evels of t he systems that will interface with the VA systems . | |
1286 | Table 25: System Sup portabilit y | |
1287 | BN 7System will inte rface with VA system sPriority Level7.2RA MS interfa cing with CITIMedium priority7 .3RAMS inc orporating the funct ionality o f WinRMSMe dium prior ity7.4RAMS incorpora ting the f unctionali ty of eJIT Medium pri ority7.5RA MS interfa cing with TMSMedium priority7. 6RAMS inco rporating the functi onality of RAFTMediu m priority 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. | |
1288 | 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. | |
1289 | 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. | |
1290 | 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. | |
1291 | 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. | |
1292 | 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. | |
1293 | 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 ). | |
1294 | 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. | |
1295 | The IT sol ution shal l be desig ned to com ply with t he applica ble approv ed Enterpr ise SLAs. | |
1296 | 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. | |
1297 | 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. | |
1298 | 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) | |
1299 | Usability | |
1300 | 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). | |
1301 | 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 . | |
1302 | In order t o improve usability of VA-deve loped or p urchased a pplication s, the fol lowing act ions are r equired: | |
1303 | 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 . | |
1304 | 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. | |
1305 | 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. | |
1306 | A sound UC D and deve lopment pr ocess base d on human factors s hould incl ude the fo llowing ac tivities: | |
1307 | Understand ing of the Users, th e Users’ t asks, and the Users’ environme nts | |
1308 | Review of similar or competiti ve systems to inform requireme nts and de sign | |
1309 | Heuristic evaluation of prior versions, prototypes , or basel ine applic ations, if applicabl e | |
1310 | 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) | |
1311 | User risk analysis | |
1312 | 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. ) | |
1313 | To demonst rate high usability, the appli cation sho uld be: | |
1314 | Intuitive and easy t o learn, w ith minima l training ; | |
1315 | Effective by allowin g Users to successfu lly comple te tasks; | |
1316 | Efficient by allowin g Users to complete their work in a mann er consist ent with c linical pr actice and workflow; | |
1317 | Perceived to have hi gh usabili ty, as dem onstrated by appropr iate surve y measures ; and | |
1318 | Designed t o aid User s in meeti ng task go als withou t being an additiona l burden. | |
1319 | The system must be r eliable an d enable U ser trust by providi ng: | |
1320 | Stable and reliable performanc e; | |
1321 | Accurate d ata; | |
1322 | 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 | |
1323 | Accessible informati on related to the so urce of da ta. | |
1324 | 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: | |
1325 | Integrated display o f structur ed and uns tructured data; | |
1326 | Rich data visualizat ion and gr aphical di splay of d ata; | |
1327 | Ability to switch be tween tabu lar and gr aphical da ta views; | |
1328 | Ability to interact with displ ayed data to obtain additional details r elated to the data a nd source of the dat a; and | |
1329 | User custo mizable co mponents a nd setting s. | |
1330 | The applic ation must provide f or advance d and up-t o-date sea rching, to include: | |
1331 | Fast searc h function ality with auto-comp lete and r eal-time d isplay of matched re sults duri ng typing; and | |
1332 | Search his tory. | |
1333 | The applic ation must provide f or advance d filterin g capabili ties, to i nclude: | |
1334 | Filtering of data ta bles, list s, and gri ds; and | |
1335 | Filtering of search results. | |
1336 | The applic ation desi gn should be modifie d to: | |
1337 | Address th e specific findings from a hum an factor heuristic evaluation conducted on the pr ior versio n of the a pplication ; | |
1338 | Address th e specific findings reported f rom field use of the prior ver sion; and | |
1339 | Address th e specific findings reported f rom usabil ity testin g of the p rior versi on or rele vant proto types. | |
1340 | Documentat ion | |
1341 | The follow ing refere nces BN4 o n the docu mentation criteria o f the RAMS training curriculum : | |
1342 | Manage dat a about pe rsonnel en gaged in r esearch at VAMC faci lities | |
1343 | 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 | |
1344 | Notify PI or PI Desi gnee and e mployee wh en trainin g is requi red includ ing annual /biannual re-trainin g | |
1345 | Appendix B : Acronyms | |
1346 | The follow ing is a l ist of acr onym defin itions: | |
1347 | Table 26: Acronyms | |
1348 | TermDefini tionACORPA nimal Comp onent of R esearch Pr otocolACOS Associate Chief of S taff AFMAn imal Facil ity Manage rAOAdminis trative Of ficerBNBus iness Need BRDBusines s Requirem ents Docum entCITICol laborative Instituti onal Train ing Talent Managemen t System ( TMS)COICon flict of I nterestCRC ontinuing ReviewCSPC ooperative Studies P rogramFYFi scal YearI ACUCInstit utional An imal Care and Use Co mmitteeIPA In-Person Authentica tion (IPA) IRBInstitu tional Rev iew BoardL ASIFLarge Scale Seis mic Invers ion Framew orkLSALoca l System A dministrat orLSILocal Site Inve stigatorMO UMemorandu m of Under standingMS MicrosoftN DONormaliz ed Data Ob jectNSRNew Service R equestOROO ffice of R esearch Ov ersightPIP rincipal I nvestigato rR&DResear ch and Dev elopmentRA MSResearch Administr ative Mana gement Sys temRCORese arch Compl iance Offi cerRDISRes earch and Developmen t Informat ion System RDMRequire ments Deve lopment an d Manageme ntREDRequi rements El aboration DocumentRP SSResearch Protocol Safety Sur veyRSDRequ irements S pecificati on Documen tSAESeriou s Adverse EventSDDSo ftware Des ign Docume ntSOPStand ard Operat ing Proced ureSRSSubc ommittee o n Research SafetySSA System Sit e Administ ratorTMSTa lent Manag ement Syst emUAPUnant icipated P roblem Rep ortVADepar tment of V eterans Af fairsVAMCD epartment of Veteran s Affairs Medical Ce nterVMUVet erinary Me dical Unit WOCWithout Compensat ionXMLExte nsible Mar kup Langua geIn addit ion to the above ref erenced ac ronym tabl e, please refer to t he RAMS Li brary for additional VA acrony m informat ion. | |
1349 | Template R evision Hi story | |
1350 | DateVersio nDescripti onAuthorSe ptember 20 151.7Updat ed Heading s and spac ing to con form with latest OIT Documenta tion Stand ards guide linesProce ss Managem entJune 20 151.6Updat ed to conf orm with l atest Sect ion 508 gu idelines a nd remedia ted with C ommon Look Office to olProcess Management May 20151. 5Revised b y the PMAS Process I mprovement Lockdown TeamPMAS P rocess Imp rovement L ockdown Te amDecember 20141.4Up dated to c onform wit h latest S ection 508 guideline s and reme diated wit h Common L ook Office toolProce ss Managem entMay 201 41.3Reorde red cover page to en hance sear ch capabil itiesProce ss Managem entMay 201 31.2Add Ap pendix for acronyms and glossa ryProcess Management March 2013 1.1Formatt ed to curr ent ProPat h document ation stan dards and edited to conform wi th latest Alternativ e Text (Se ction 508) guideline sProcess M anagementJ anuary 201 31.0Initia l VersionP MAS Busine ss OfficeR AMS Integr ation | |
1351 | Requiremen ts Specifi cation Doc ument | |
1352 | 13 | |
1353 | July 2016 |
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