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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