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

What is the investigator's primary concern when a subject wishes to withdraw from a trial prematurely?

1. To ensure safety of the subject

2. To obtain the subject's reason for withdrawal

3. To notify the IRB

4. To find a replacement subject

The correct answer is: To obtain the subject's reason for withdrawal

The primary concern of the investigator when a subject wishes to withdraw from a trial prematurely is to obtain the subject's reason for withdrawal. Understanding why a participant chooses to leave the study is crucial for several reasons. First, the investigator can assess whether there are any safety or ethical concerns associated with the trial that may need to be addressed. Second, knowing the reason for withdrawal can provide valuable insights into the trial’s design, its procedures, and participant experience, which can help improve future studies. Gathering this information helps the investigator evaluate the trial’s impact on participant retention and adherence, and it can guide modifications to enhance participant satisfaction. While safety is a critical consideration, especially during the withdrawal process, the priority lies in understanding the participant’s perspective and reasons for their decision. It helps the investigator ensure that any issues that could be impacting the safety or well-being of participants are effectively managed and mitigated in the future.