Study Oversight, Maintenance and Reporting

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IRB Continuing Review

Definition

  • Institutional Review Board (IRB) continuing review is the process whereby the IRB reviews and extends approval dates for an IRB-approved study.

Policies/guidelines

  • PIs will receive the expiration date for their IRB approval at the time of the initial approval and with each subsequent continuing approval. After the initial approval, principal investigators (PIs) are required to submit continuing reviews every year to update the IRB on the research and to extend the IRB approval period. Prior to the IRB approval’s expiration date, you must submit a continuing review report to the IRB. Continuing reviews are submitted electronically through the IRB’s Ideate (application).
  • As a courtesy to investigators, Ideate sends three renewal reminders, at 90, 60 and 30 days prior to expiration.
  • Investigators must submit the following for continuing review:
    • The most recent report from the DSMB or DMC (if applicable)
    • The most recent multi-center progress report (if applicable)
    • The continuing review application form (progress report)
  • Important information about continuing review for external IRBs:
    • About two months before the expiration date listed on the Certificate of Action (approval letter), your IRB will begin soliciting information about the status of the study at your site.
    • At that time you or your sponsor may also receive a form soliciting information about the status of the research across all sites (for multicenter studies).
    • If the IRB doesn’t receive the completed form by the due date listed on it, it may take action to restrict the conduct of the research until the information is provided.
    • The FDA guidance document titled “IRB Continuing Review after Clinical Investigation Approval” (external site) will provide more information about this activity.

Training

  • Contact the Human Research Office at (601) 984-2815 for more information on submitting continuing reviews.