Which document is used to document signatures and initials of all persons authorized to make entries and/or corrections on case report forms?

• A. Audit Certificate
• B. Signature Sheet
• C. Final Trial Close-Out Monitoring Report
• D. Completed Subject Identification Code List

Answer: (B)

Documenting who is authorized to enter data and make corrections on case report forms is essential for accountability and data integrity in clinical trials. A Signature Sheet serves exactly this purpose by recording the signatures and initials of every person who has the authority to enter or modify CRF data, and often the dates of those actions. This creates a clear audit trail so monitors and auditors can verify that only designated personnel performed data edits and that those edits can be traced to a responsible individual.

Other documents serve different roles: an Audit Certificate relates to external audits; a Final Trial Close-Out Monitoring Report summarizes monitoring activities at study end; and a Completed Subject Identification Code List is used for subject confidentiality and coding.