Which document describes the written description of a change to the protocol?

• A. Protocol
• B. Randomization
• C. Source Data
• D. Protocol Amendment

Answer: (D)

A protocol amendment is the written record that documents changes made to the study protocol after the study has begun. It specifies what is changing, why the change is needed, and how the study procedures, assessments, or timelines will be modified, along with any implications for participant safety and data collection. The protocol itself is the original plan, so a protocol amendment is the formal description of the modification to that plan. Other terms refer to different things: randomization describes how participants are assigned to groups, and source data are the original records of what was observed or collected. Protocol amendments are typically reviewed and approved by the sponsor and the IRB/IEC before they are put into effect, and consent forms may need updating if the changes affect participants.