Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is the primary purpose of an initiation visit in clinical trials?

1. To finalize the study budget

2. To review the protocol of the trial

3. To recruit new participants

4. To conduct training for site staff

The correct answer is: To review the protocol of the trial

The primary purpose of an initiation visit in clinical trials is to review the protocol of the trial. This visit is crucial as it sets the stage for the study by ensuring that all parties involved have a clear understanding of the study objectives, methodologies, and requirements. During this meeting, the trial protocol is thoroughly examined, and discussions may include the study design, inclusion and exclusion criteria for participants, operational processes, and timelines. Understanding the protocol is fundamental for the proper execution of the clinical trial as it guides the researchers and site staff in adhering to the set standards and practices. Ensuring that everyone is aligned with the protocol helps mitigate risks related to regulatory compliance, participant safety, and data integrity. While finalizing the study budget, recruiting new participants, and conducting training for site staff are important aspects of the clinical trial process, none of these components can efficiently take place without a solid foundation provided by the protocol review. Thus, the initiation visit primarily focuses on ensuring that everyone involved is informed and prepared to execute the study as outlined in the protocol.