GCP of Devices Practice Test

The key idea here is that consent forms themselves carry the evidence of approval and use. An informed consent form is the document that a subject signs to enroll in a study, and it must be IRB-approved before it can be used. Each version that is used to enroll participants should have its own IRB approval record, and the form itself typically shows the version number and effective date. That combination—an IRB-approved, versioned consent form that was actually used to enroll subjects—provides clear evidence that all versions employed in enrollment were reviewed, approved, and put into use.

Other documents don’t directly demonstrate that all consent-form versions were approved and used. An Investigator Agreement covers responsibilities; protocol or CIP amendments show changes to the study and may include consent form updates, but they don’t by themselves prove the approval and use of every consent form version. OHRP notification relates to regulatory status and does not document consent form approvals.