ࡱ>  bjbjVV p<`p<`Xwt t 8SD4R4(55533333336935"553  4aaa5d3a53aa*|+0/(h++3"40R4=+~4:!4:$++4:},d55a5555533555R455554:555555555t Y :  Principal Investigator _____________________________ Site Name/# ___________ Study Title IRB # ___________ Protocol Name/# ___________ Sponsor Reason Study has closed: Date of Closure _________ Closeout Preparations: Confirm all study activities, study visits and follow-up procedures have been completed, including resolution of SAEs and protocol deviations. Schedule and conduct closeout visit with sponsor representative/sponsor-investigator. This visit may be done via remote or an in-person visit. Resolve any pending monitoring findings/queries (note: data may be entered or corrected on Case Report Forms [CRFs] until the studys database has been locked and the study terminated with the IRB). Request and have available any subject medical records or source documents that may need to be reviewed by monitor. Review and ensure all essential/regulatory documents are current, complete, accurate, and filed appropriately and make available to monitor at closeout visit. Review and ensure all research records are current, complete, accurate, and filed appropriately and make available to sponsor representative/sponsor-investigator at closeout visit. Ensure notes-to-file exist for any violations/deviations/occurrences that require additional explanation. Return/destroy investigational product/supplies/study materials according to sponsor/CRO/funding agency/institutional requirements and maintain all required documentation of events. Reconcile any investigational product/supply discrepancies. Closeout accounts with RAS and OSP (work with research administrator(s); ensure all outstanding monies have been reconciled). Study Closeout: Submit final closeout to IRB and file with study documents. Notify applicable parties/regulatory authorities of the study closure and submit final reports (e.g., the FDA for investigator-initiated, FDA-regulated research). File closeout visit report from sponsor/CRO/sponsor-investigator, if applicable. After Study Closeout: Ensure access to electronic systems have been terminated, as applicable. Record retention of all study materials and documents per institutional policy. Create a written inventory of all items to be stored (example of form attached). Update financial disclosures of investigators and key personnel if any relevant changes occur in the course of the study or for one year following completion of the study, if applicable. Documents must be stored securely and with adequate protection of participant confidentiality for a period as specified in clinical trial agreement, funding agency requirement, or Institutional requirements. This applies to both electronic and paper records. Date Records archived to storage _______________ Date for data destruction (obtain written permission from sponsor prior to destruction) ______________ Site for long-term storage Comments Signature indicating above tasks have been completed. _______________________________________ ____________________ Principal Investigator Date Sample Archive Form Please modify the sample form below as applicable to the research project and method of storage. Study: _____________________________________________________________________________ Protocol Title: _______________________________________________________________________ Sponsor: ___________________________________________________________________________ Protocol #: _________________________________________________________________________ Investigational Product (drug/device, if applicable): _________________________________________ Indication, if applicable: _______________________________________________________________ IRB protocol #: _____________________________________________________________________ Site #: ______, ԰ɵ/College of Medicine/Salus/Other:____________________________ PI: ______________________ /Coordinator: ______________________________________________ IRB Approval Date: __________________________________________________________________ IRB Closure Date: ___________________________________________________________________ # Participants Enrolled: _______________________________________________________________ # Screen Failures: ___________________________________________________________________ Document Storage Location: Inventory of Paper Records - # of boxes: ______________ Contents: (affix bar code labels to this form if using external vendor for storage) Box 1: (add detailed description of the contents of each box) Box 2: Box 3: Inventory of Electronic Records: (add a detailed description below of where and how electronic records are stored, including who maintains access to the records) Storage Date: _______________________________________________________________________ Storage Requirement: _________________________________________________________________ Date of planned destruction: ____________________________________________________________ Written permission to destroy (confirm prior to destruction) ___________________________________ Date destroyed: ____________________________________________________________________ Sponsor Contact:      Study Closeout Checklist Page  PAGE 1 of  NUMPAGES 3 Version 1/24/2025 ORI-620 Supplement :?DEFQR^_`cdevD S _ z | |xtttxm hmMht@h hBVhA[hD-hA[5 hD-5 hBV5h hD->* hmMhu/hmMhu/>*hgNqh OJ hmMh*hmMh nq>* hmMh nqhmMh0mHsHh!mHsHhmMh*mHsHhmMh nqmHsHh nqhg5OJQJ^J*R`| F  w & F 8hh^h`gdrl] & F 8hh^h`gdBV & F 8hh^h`gd nqgdA[ `'gd nqgd nqgd* ;  D E F R \ ] e g z { ~     # + , 1 D I L [ q Ӥ㫲ӝ hmMh5 C hmMh/n hmMh nq hmMh8I hmMhI hmMhBVhVhh2hBVh OJhshgNqh/>h=j5 hmMht@ hmMh2 hmMhu/>     6 F _ z  BYtuvwxfgz+,0Mfhrstu)CDwؿؿشحԭܴȢhJMh+* hmMhmM hmMhhahW h=hW hBV5h/>h OJh=j5hA1hhahBV hmMhBVhD- hD-hD-hgNq hmMh hmMhI*hmMh >* hmMh  hmMh/nh, hmMh/>hJMh/>h5 C hmMhpb hmMhA hmMh5 ChmMhg>* hmMhmMhmM/:<rst$a$gdA1 9D[$\$gd  x9D[$\$gd  `'xgd `abξukd h=h=h=h=5\#h/}h/}5B*CJ\aJphh/}5B*CJ\aJphh=5CJ(\aJ(h=h=5CJ(\aJ(h/}5B*CJ(\aJ(phhXmH sH h OJmH sH hA1mH sH hmM hmMh1ih, hmMh %hmMh)qB*CJOJQJaJph&abdv,2gd=gd=$a$gd=gd/}$a$gdA1$cdt%4Uuv+,=Fgt/26@P .89:tʿh/}h=B*phh/}B*phh=h=>*h/}h=OJQJ^Jh=h=OJQJ^J h=h=h=K9:3EFW^gd= & Fgd=gd= &d P gd=23\tDEFWXYZ[\]^_`abcdefghi~l#jhh5CJU\aJhhCJaJhmW h OJhh OJh5CJ aJ #h OJh OJ5CJOJQJ^JaJh2 5CJOJQJ^JaJh OJ5CJ OJQJ^JaJ jh UmHnHuh$Mjh$MUhmMhA1mH sH h/} h=h=)WXZ[]^`acdfghi $xa$gd OJ$a$gdgdiu$a$gdA1ັhmMhA1mH sH h5 ChmWhhA1CJ\aJhJCJ\aJh OJCJ\aJh5CJ\aJhhCJaJh['5CJ\aJmHnHu#jhh5CJU\aJhh5CJ\aJ21h:pX/ =!"#$% n>~8>dÏPNG  IHDRB_sRGBgAMA a pHYsod IDATx^Umy-m @  هiR$7"`/"?AE#'DA$d_;3/ζW{=\c0! 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