If IRB/IEC requires changes to the protocol or consent, what should the sponsor obtain?

• A. The investigator's personal notes
• B. A copy of the modification(s) and the date approval/favorable opinion was given
• C. The sponsor's training logs
• D. The subject's medical records

Answer: (B)

When the IRB/IEC requires changes to the protocol or informed consent, those changes must be officially approved before they are used in the study, and the sponsor needs documentation of that approval. The sponsor should obtain a copy of the modification(s) and the date the IRB/IEC gave its approval or favorable opinion. This provides a verifiable record that the amendments were reviewed and approved and specifies when they may be implemented, which is essential for compliant trial conduct and for re-consenting participants if required. Investigator notes, training logs, or a subject’s medical records do not document IRB approval and aren’t the appropriate evidence of approval for protocol or consent changes.