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

What should the investigator prioritize when a subject wishes to withdraw prematurely from a trial?

1. Respect the subject's decision without inquiry

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

3. Refer the subject to the study coordinator

4. Contact the sponsor directly for instructions

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

When a subject expresses the desire to withdraw prematurely from a clinical trial, it is essential for the investigator to prioritize understanding the reason for this decision. Trying to obtain the subject's reason for withdrawal is crucial for several reasons. First, this information can provide valuable insights into the trial's conduct, including aspects such as the intervention's tolerability, potential adverse effects, or the subject's personal circumstances that might be influencing their decision. Understanding why a participant wants to withdraw can help identify areas for improvement in the study protocol or participant experience. Additionally, if the subject's reason for withdrawal relates to specific concerns about the trial, the investigator may be able to address these concerns directly at that moment, potentially alleviating any reservations the subject has and encouraging them to continue their participation in the study. Moreover, documenting a participant's reason for withdrawal is an important aspect of regulatory compliance and good clinical practice. It ensures that the data collected during the trial accurately reflects participant experiences and can aid in the analysis of the overall study outcomes and safety profile. While respecting a subject's autonomy is vital, gathering information about their decision allows for a deeper understanding of the study's impact and can lead to improvements in future trials.