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kchlvri and RWOfdr office 3. DECLARATION THAT W SUBJECTS EITHER YOOLD OR W L D NOT BE INVOLVED OA. No in divi d rul # vbo might be coal i dud bun aubjecta. including thoaa from whom organa, tiamas, fluids. or other u cert a la mld be derived, or ubo wuld be ld mt if id by peraortal date. wuld k fm01v.d fa the prapaaed eet iv iq. (If no bumen rub j acts would b s involved. chsck chi. box end proceed t o it- 7.) Buman N bj eCt l Wuld be involved in the proposed activity.OB. Subjecta uould include; ONONE of the f011aing. [3aiors, mfatusu. Oeborttuaa, D pregnant men, n prisoner a.Ou e Ull y retarded. O un tally die eb ld. Under section 6 . Cooperecfng control of tb. applicant or offaring ilutitutbn. DA. This innticution doe* not h a en active saauranca on fils rich Dtw tht emus or epp lies LO this spp liut ioa. When r mu este d br Dtw chi. inn tft uti on rill sukit an aamrance end h plm eu t ation pro ed ursa to com pl ~with the rmquircunta of tb. or ao active special ansurenee for tbia ongoing eetivit7. on fila rich KEJW. "ha signer U II RFX LS tht a11 sc tir ici u in this app liut ion proposing LO involve huun N bj ect sh Ve been reviewed and appr ov d by this fa*Citutia,'s In at it uti one l Win Doerd in a convened meeting on t h e data of 145 CFR 481. TU. certificatia, includaa. uhen applicable. rmquirwmts for certifying €'DA status for uch in vu tiga tion elan drug t o be rued (see reveres aids Of Chi# foru). Tba Institutional lcrieu Wrdhs determined, and theia et it uti or d official siguing in accordance with t h e oh mu^ eu b jeet s rill not be e t risk; 0 Inmu mb j act l will be at risk. 5. and 6. SEE REVERSE SIDE 7. SIGNATURE OF INSTITUTIOHAL OFFICIAL date
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Section 46.17 of Title 45 Of the cod. Of POd.ml & gUf & h Wtate8. "Mure 01 orgQIiarreim w required w p - pmr or to nubnit ao ert ifk tion...d the pavposal involtme m invest iga tio ml new tirug within the nUrning Of !l'he Food, m'ug. and Conntic ACZ. the dw shall be identified i n the oertifioaticn together oith a atatanent that the tO-&y doh!, prior to upination of .uoh SO-& iwhrval, repeated that the aponaor eat iru w vi~h,&f or to nat riot we of the drug i n humn enbjeate; or that the Food md Dn qX M nia tmi - h wived the SO+ dllq requi-t; pmvided, hadever, that i n thora cunea ir. vhich tho DREU vpon moh orpimticn or vpon lumipt of a uoivu. b'o cart if im tic n shall h mnsi&lud acceptuble until such atatumnt hiu hen re a dvd. " INVESTIGATIONAL NEY DRUG CERTIFICATIOW TO Certify compliance vithm requirement8 for propoied w e of investigation kl new druya in addition to certification of In at it uti ml Review bard approval, the following repit - Name of IND end sponsor - Date of )Way expiration or ?M u air er - Signature of ime sti ; at or date (future date re quir u followup report to nwr) 6. COOPERATING INSTITUTIONS - ADDITIONAL REPORTING REQUIREMENT Section 46.16 of Title 45 of the Codr of Pd.ra1Reguf & h impoaea apecia1 requirement. on the conduct of atudiea or act ivf tiu in vbich the grantee or pri ne contractor obtain# access t o a11 or erne of the aubjecta through cooperatin$ in et it ut ions not under ica Use follouirq report for ut for uchi nmt it uti on other th.n granter or contracting ht it uti on with reap omi bil it y for Intun aubjectr participating in thi a activity : (attach additional report sheets as nacesaaq). In order tbat the DfIEy be fully informed, the fol lou ing report is requerred - Official of cooperetin; i wt it uti on autborizin; accesa to sub jsc ta. - Name and address of in et i cut ion umber ege rmge