When a subject withdraws from the trial, which data should be collected?

• A. The reason for withdrawal and the last assessment results
• B. Only the date of withdrawal
• C. No data collection post-withdrawal
• D. Sponsor's billing information

Answer: (A)

When a subject withdraws, you collect the reason for withdrawal and the last assessment results. Recording the withdrawal reason helps you interpret attrition, assess safety signals, and understand any potential biases in the study data. The last assessment results provide a final snapshot of the subject’s status at withdrawal, including relevant safety data (like adverse events, labs, vitals) that are essential for safety monitoring and for preserving the integrity of the dataset. Data up to the withdrawal point should be retained and analyzed as part of the trial results; data beyond withdrawal are not typically collected unless the protocol specifies a follow-up. The sponsor’s billing information isn’t part of the clinical data and isn’t relevant to understanding the subject’s safety or efficacy outcomes.