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Update to Post Approval Monitoring Checklists

Dear Research Community,

The Compliance Unit of the Northwestern Institutional Review Board (IRB) has made significant changes to the post approval monitoring checklists. Changes include the revision of current checklists and the release of three new supplemental checklists.

The current suite of documents are:

  • HRP-427 – CHECKLIST Post Approval Monitoring: Drug or Device Clinical Trial
  • HRP-428 – CHECKLIST Post Approval Monitoring: Participant File
  • HRP-429 – CHECKLIST Post Approval Monitoring: Biomedical Research
  • HRP-430 – CHECKLIST Post Approval Monitoring: Social Behavioral Research
  • HRP-1405 – CHECKLIST Post Approval Monitoring: Registry, Data Review, and/or Specimen Collection NEW!
    • For use in studies involving data reviews, registries, and/or sample collection and retention
  • HRP-1406 – CHECKLIST Post Approval Monitoring: Studies Under IRB Review NEW!
    • For use in studies that cede review to an external IRB
  • HRP-1407 – CHECKLIST Post Approval Monitoring: Site File NEW!
    • For use in studies in which the Northwestern IRB serves as the IRB of record for 1 or more sites

Post approval monitoring can be conducted routinely or for cause by the Compliance unit, as well as self-assessments conducted by the investigator and/or study staff.

Checklists can be found in the Templates, Forms, & SOPs tab of the website.

Thank you,

Northwestern University IRB