What constitutes a protocol amendment and when should it be approved?

• A. A change to study design, objectives, eligibility criteria, procedures, or endpoints; major amendments require IRB/IEC approval and regulatory notification; minor amendments may require institutional notification.
• B. A change only to the study funding source; no approval needed.
• C. A change to the investigator's badge color; no approvals.
• D. A change to the principal investigator's personal address; requires internal memo.

Answer: (D)

Protocol amendments are formal changes to the study protocol that affect how the trial is conducted, such as changes to design, objectives, eligibility criteria, procedures, or endpoints. Because these changes can impact participant safety and the integrity of the data, they require oversight before they’re put into practice. Major amendments—those that alter risk to participants, scientific validity, or overall conduct—need IRB/IEC approval and regulatory notification. Minor amendments, which don’t affect safety or key methodology, may only require institutional notification depending on the local rules. For example, adding a new eligibility criterion or changing the primary endpoint would be a major amendment, while updating administrative details like funding sources or investigator contact information would not be.