What must be obtained before initiating any protocol deviation?

What must be obtained before initiating any protocol deviation?

• A. Verbal confirmation from the subject
• B. Prior written IRB/IEC approval of an appropriate amendment
• C. Sponsor's consent only
• D. Written notification to regulatory authorities

Answer: (B)

When a change to the study is planned, you must secure written approval from the IRB/IEC for an appropriate protocol amendment before implementing it. This oversight ensures any deviation that could affect participant safety, rights, or data integrity has been reviewed and ethically sanctioned, with the informed consent document updated as needed. Verbal confirmation from the subject isn’t sufficient because consent and changes must be documented and approved in advance. Sponsor consent alone does not replace IRB/IEC review, and notifying regulators is a separate requirement that follows approval and is not the prerequisite to starting the deviation.

When a change to the study is planned, you must secure written approval from the IRB/IEC for an appropriate protocol amendment before implementing it. This oversight ensures any deviation that could affect participant safety, rights, or data integrity has been reviewed and ethically sanctioned, with the informed consent document updated as needed. Verbal confirmation from the subject isn’t sufficient because consent and changes must be documented and approved in advance. Sponsor consent alone does not replace IRB/IEC review, and notifying regulators is a separate requirement that follows approval and is not the prerequisite to starting the deviation.