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1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App2Instructions.docx | Thu May 17 00:40:54 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp\ACORP | ACORP_App2Instructions.docx | Tue Jul 17 21:18:48 2018 UTC |
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1 | Instructio ns for Com pletion of the | |
2 | ACORP Appe ndix 2 – A ntibody Pr oduction | |
3 | (ACORP App . 2 Instru ctions) | |
4 | Version 4 | |
5 | ||
6 | ||
7 | These inst ructions p rovide det ailed guid ance on co mpleting A ppendix 2 of the ACO RP, and ar e referenc ed to the numbers of the items in Append ix 2. ONLY complete this appen dix if it is relevan t to the p rotocol be ing submit ted for re view. The PI may use the ACORP Appendix 2 template provided in the RAM S applicat ion by usi ng the lin k availabl e in quest ion 10 of section M. | |
8 | ||
9 | General In structions : | |
10 | Answer eac h question by comple ting the t able provi ded or ent ering the requested informatio n at the ► . Enter “N /A” for an y item tha t does not apply to this proto col. The sections o f the form will expa nd as need ed. | |
11 | To check a n item, ty pe “X” ins ide the ( ) provid ed. | |
12 | Define eac h abbrevia tion the f irst time it is used . | |
13 | ||
14 | Header for Every Pag e. The he ader infor mation for this appe ndix is pr e-populate d to match header fo r the Main Body of t he ACORP t o which it applies, to identif y each pag e of this Appendix w ith that A CORP: | |
15 | PI’s last name: The PI’s name is prepopu lated | |
16 | Protocol N o. Assigne d by the I ACUC – Thi s is a uni que identi fier for e ach protoc ol that is automatic ally gener ated by th e system t o the prot ocol as a whole | |
17 | ||
18 | Official D ate of App roval – Th is is the date of fi nal and un equivocal approval b y the IACU C, as defi ned in the PHS Assur ance, whic h determin es the due dates of the first annual con tinuing re view and t he trienni al de novo review, a s applicab le. The IA CUC commit tee will e nter this date into the form w hen a deci sion is ma de. | |
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20 | Immunizati on. Immun ization of animals i s essentia l to the p roduction of polyclo nal antibo dies, and is the fir st step in creating new hybrid omas for p roduction of monoclo nal antibo dies. Doc ument the immunizati on protoco l for any animal tha t will be immunized on this pr otocol. De scribe any priming i njection b y entering a negativ e number f or the imm unization day (the n umber of d ays before the first injection of antige n), “N/A” for the an tigen, and the descr iption of the primer in the co lumn for t he adjuvan t. For ea ch primer, antigen, and adjuva nt that is expected to cause p ain or dis tress in t he animals , explain why it is necessary to use thi s agent in this prot ocol. Eac h primer, antigen, a nd adjuvan t administ ered to th e animals should als o be docum ented in A ppendix 3. | |
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22 | Survival B lood Colle ction. Co llection o f blood fr om animals that are to survive the proce dure requi res consid eration of the volum es of bloo d that can be safely removed, the possib ility of v olume repl acement, a nd appropr iate admin istration of anesthe tics, tran quilizers, and/or an algesics. This blood collectio n should a lso be doc umented in Item R of the ACORP . | |
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24 | Terminal B lood Colle ction. Co llection o f blood by exsanguin ation requ ires appro priate man agement of the eutha nasia, whi ch should be describ ed in Item U of the ACORP. Th is blood c ollection should als o be docum ented in I tem R of t he ACORP. | |
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26 | Harvesting Feeder Ce lls. If c ells must be harvest ed from do nor animal s to suppo rt the gro wth of hyb ridoma col onies for the antibo dy product ion on thi s protocol , the proc edures per formed on the donor animals mu st be desc ribed. The harvestin g of feede r cells sh ould also be documen ted in Ite m R of the ACORP, an d the numb er of anim als to be used for t his must b e included in Item I of the AC ORP. | |
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28 | Expansion of Hybrido ma Cell Li ne(s) in v ivo. Use of animals to expand hybridoma cell line s so that antibody c an be harv ested from ascites f luid requi res consid eration of the effec ts of the injection and growth of the hy bridoma ce ll line(s) , and of t he abdomin al taps to be perfor med, on th e host ani mals. See guideline s for mono clonal ant ibody prod uction in “Working w ith the VA IACUC” (w ww.citipro gram.org). The anim als used f or this sh ould be in cluded in Item I of the ACORP, the primi ng agent a nd the hyb ridoma cel ls documen ted in App endix 3, a nd the col lection of ascites f luid inclu ded in Ite m R of the ACORP. | |
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30 | If any of the proced ures descr ibed in th is Appendi x represen t “departu res” from the standa rds in the Guide, be sure to i nclude tho se “depart ures” in A ppendix 9. Consult the IACUC or the Att ending Vet erinarian for help i n determin ing whethe r any “dep artures” a re involve d. |
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