Regulatory Binder Checklist
Principal Investigator:
IRB #:
Study Title:
Sponsor:
| |All Studies: |
|□ |All IRB approved versions of the protocol |
|□ |All IRB approved consent forms with watermark/date |
|□ |IRB approval memos for all amendments |
|□ |IRB approved advertisements/recruitment materials (brochures, flyers, web ads, etc.) |
|□ |Written information provided to subjects (pain scales, diaries, questionnaires, etc.) |
|□ |Initial IRB approval memo |
|□ |Continuing Review approval memo(s) |
|□ |Final Report to the IRB |
|□ |CVs and licenses of PI and Co-PIs (update every 2 yrs/license annually) |
|□ |Copy of Medical licenses |
|□ |Site responsibility/staff signature log |
|□ |Subject screening/enrollment log |
|□ |Retained body fluids/tissue Sample Log |
|□ |Protocol Deviation tracking log |
|□ |DSMB Reports |
|□ |Sponsor correspondence |
|□ |Registration of clinical trial |
| | |
| |Multicenter Studies in which WFUHS is the Prime Site: |
|□ |All IRB approval memos from collaborating/subcontracting sites |
|□ |All IRB stamped consent forms from collaborating/subcontracting sites |
|□ |All IRB approved versions of the protocol from collaborating/subcontracting sites |
|□ |Authorization agreement (if applicable) |
|□ |Individual Investigator agreement (if applicable) |
|□ |Data use agreement (if applicable) |
| | |
| |Multicenter Studies in which WFUHS is not the Prime Site: |
|□ |Subcontract agreement (defines scope of work, responsibilities, etc.) |
| | |
| |NIH sponsored studies: |
|□ |Copy of the NIH grant application |
|□ |All progress reports submitted to NIH |
|□ |NIH correspondence |
| | |
|□ |FDA Regulated Studies: |
|□ |1571 (If applicable) |
|□ |Signed 1572 |
|□ |FDA Form 3455 Financial Disclosure Forms for PI and sub-investigators on 1572 |
|□ |IB/Package Inserts/IDE information |
|□ |All Investigational product shipping and receipt records |
|□ |FDA correspondence |
|□ |Drug/Device Accountability Logs |
|□ |Lab certifications (CLIA) |
|□ |Lab Director’s CV |
|□ |Lab normals |
|□ |Laboratory Shipment Log |
|□ |Investigational New Drug (IND) safety reports received from Sponsor |
| | |
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