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

What is the first priority for an investigator if a subject wishes to withdraw from a clinical trial?

1. Complete the final assessment

2. Report to the sponsor immediately

3. Try to obtain the subject's reason for withdrawal

4. Encourage the subject to continue

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

When a subject expresses a desire to withdraw from a clinical trial, the first priority for an investigator is to try to obtain the subject's reason for withdrawal. This approach is crucial for several reasons. Understanding the subject's reasons for wanting to leave the trial can provide valuable insights into the study's design or execution. It may reveal issues related to the intervention being tested, the study procedures, the level of patient engagement, or other factors that could impact the integrity of the trial. Gathering this information is essential for improving future studies and ensuring that the needs and concerns of participants are addressed. In addition, focusing on the subject's feelings and perspectives can foster a sense of respect and trust, allowing the investigator to support the participant’s decision-making process. This action can contribute to the ethical conduct of the trial, ensuring that participants feel heard and valued, regardless of their choice to withdraw. While completing a final assessment, reporting to the sponsor, and encouraging the subject to continue are important tasks during the withdrawal process, they are secondary to understanding the reasons behind the subject's decision. A clear grasp of those reasons can shape subsequent actions and decisions in a meaningful way.