What follow-up is advised for subjects who withdraw from treatment?

• A. Follow-up for collection of vital status or data where possible
• B. No further contact after withdrawal
• C. Mandatory re-consent
• D. Replacement subjects immediately

Answer: (A)

Even after a subject withdraws from treatment, it’s important to try to obtain follow-up information that keeps safety and study data complete. Collecting vital status and other data planned by the protocol, whenever possible and within the scope of the consent, helps determine if withdrawal is related to safety issues, maintains the integrity of the safety signal, and supports accurate analysis of study outcomes. This follow-up should respect the participant’s preferences—if they explicitly request no further contact, those wishes must be honored.

This approach is preferred over stopping all contact or replacing participants, which would lead to incomplete data and biased results, and over mandating re-consent for follow-up data collection, which is typically not necessary for information already covered by the original consent.