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  • IRB Submissions (application, consent forms, supporting documents)

  • IRB Approval Letters

  • Continuing Review(s)

  • Amendments

  • Adverse Events

  • Violations/Deviations

  • Reporting Forms (DSMB reports, Investigator drug/device brochure updates)

  • Close out Information

  • Investigator response(s) to IRB notification (if applicable)

IRB Decisions

  • Approval letters and/or notification of IRB decisions

  • Approved recruitment materials

  • Approved educational materials/additional study information distributed to subjects (e.g. subject diary)

  • Info regarding Federalwide Assurance (FWA); IRB registration and IRB membership (3/2011)

  • Letter to Sponsors

  • Any additional correspondence relating to the study (e.g. e-mails)

Tips/ Additional Information

  • Copies of all signed and dated IRB submissions and correspondences between the study site and IRB should be kept on file.

  • The QIU recommends filing documents in reverse chronological order to ensure that documentation provides an accurate history/timeline of study activity from approval to completion. Only one copy of each correspondence is needed.

  • Request a copy of any missing documents from your protocol administrator or print them fto include in the binder.

  • If documents are filed electronically, write a signed and dated note to file indicating the location.

  • If signed and dated correspondences cannot be maintained electronically (e.g. pdf version), keep a hard copy on file.

  • Regulations/Guidelines-45 CFR 46

  • 21 CFR 50

  • 21 CFR 56

Regulations/ Guidelines

  • 45 CFR 46

  • 21 CFR 50

  • 21 CFR 56


Supporting research today to meet Veterans' health needs tomorrow!

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