What happens to the Trial Master File (TMF) after a study is completed?

• A. Archiving the Trial Master File after study completion.
• B. Deleting the TMF immediately after completion.
• C. Publicly posting the TMF online.
• D. Keeping TMF only on one device.

Answer: (A)

After a study is completed, the Trial Master File is archived to preserve essential trial documentation for regulatory review and future audits. The TMF contains records that demonstrate the study was conducted in accordance with good clinical practice and that data were generated and managed properly. Archiving ensures the documents are securely stored, remain retrievable for the required retention period, and are protected from loss or unauthorized access. Deleting the TMF immediately would erase critical evidence and violate retention obligations. Publicly posting the TMF is inappropriate due to confidentiality and data protection concerns. Keeping the TMF only on one device increases the risk of loss or damage and does not meet best practices for durability and compliance; archiving uses a secure repository with backups, access controls, and defined retention periods.