Which document records that amendments and/or revisions have been subject to IRB/IEC review and were given approval/favorable opinion, and identifies the version number and date of the documents?

• A. Any Revision to Trial Documents
• B. Dated, Documented Approval/Favorable Opinion of IRB/IEC of Trial Related Documents
• C. Master Randomization List
• D. Shipping Records for Investigational Products

Answer: (B)

The main idea here is that regulatory records must show that any changes to trial documents were reviewed and approved by the IRB/IEC, with clear version control. In practice, when amendments or revisions are made to protocol, consent forms, or other trial-related documents, the IRB/IEC must issue an approval or favorable opinion before those changes are used. The best document to prove this is the dated, documented approval/favorable opinion from the IRB/IEC for the trial-related documents, which also identifies the exact version and the date of those documents.

This record provides a clear, auditable trail: you can see which version of each document was approved and on what date, ensuring that participants are protected by using only IRB-approved materials and that the regulatory file reflects the current, authorized documents. It also helps inspectors verify that no unapproved revisions were implemented.

The other options don’t fit this role. A generic note of “any revision” doesn’t guarantee IRB review or provide the date and version evidence. A Master Randomization List or shipping records are unrelated to IRB approvals of trial documents and do not document regulatory approvals or versioning.