If a subject withdraws prematurely, what should the investigator do regarding the reasons?

• A. The investigator should make a reasonable effort to ascertain the reasons, while respecting the subject's rights.
• B. The investigator should not seek reasons under any circumstances.
• C. The subject must provide a written reason for withdrawal.
• D. Withdrawal should be reported to the sponsor immediately.

Answer: (A)

When a subject withdraws early, you should make a reasonable effort to understand the reasons for withdrawal, while respecting the subject’s rights and privacy. You can ask in a non-coercive way and document any reason the subject provides in the subject’s records. If the subject declines to give a reason, note that the reason was not provided. This helps interpret data and address any safety or protocol issues, while ensuring the subject’s autonomy is respected. If safety concerns arise, follow the study protocol for monitoring and inform the sponsor as required.