Virtual Regulatory Binder: IRB

Last revised: 


  • 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)

QIU 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

Applicable GCP sections: