Good Clinical Practice (GCP) Practice Exam

What is a Protocol Amendment?

1. A plan for improving patient recruitment

2. A document detailing changes or clarifications to the protocol

3. A summary of safety findings from the trial

4. A budget adjustment document

The correct answer is: A document detailing changes or clarifications to the protocol

A protocol amendment is a document that outlines specific changes, additions, or clarifications to an existing clinical trial protocol. This can include modifications to the study design, methodology, participant eligibility criteria, or any other aspect of the clinical trial that requires adjustment after the initial protocol has been approved. Implementing a protocol amendment is crucial for maintaining the integrity and scientific validity of the trial while ensuring that any updated procedures align with regulatory requirements and ethical standards. This process allows researchers to adapt to new information or challenges encountered during the study without compromising participant safety or data quality. In contrast, other options like improving patient recruitment, summarizing safety findings, or budget adjustments do not accurately describe what constitutes a protocol amendment. These elements may be relevant to the broader context of clinical trial management, but they do not specifically pertain to the formal documentation of changes made to the study protocol itself.