Which term describes documentation that allows reconstruction of the course of events?

Which term describes documentation that allows reconstruction of the course of events?

• A. Audit
• B. Audit Trail
• C. Blinding/Masking
• D. ADR

Answer: (B)

An audit trail is a time-stamped, detailed record of who did what and when, created to document every data entry, change, or action in a study. This makes it possible to reconstruct the entire sequence of events, from initial data capture through edits and finalization, which is essential for data integrity and regulatory review. Blinding/Masking is about concealing information to prevent bias, not recording event history. An audit is a broader review of processes and compliance, not the specific chronological log of dataset actions. ADR refers to adverse drug reactions, not documentation of events. So, the term that describes documentation enabling reconstruction of the course of events is the audit trail.

An audit trail is a time-stamped, detailed record of who did what and when, created to document every data entry, change, or action in a study. This makes it possible to reconstruct the entire sequence of events, from initial data capture through edits and finalization, which is essential for data integrity and regulatory review. Blinding/Masking is about concealing information to prevent bias, not recording event history. An audit is a broader review of processes and compliance, not the specific chronological log of dataset actions. ADR refers to adverse drug reactions, not documentation of events. So, the term that describes documentation enabling reconstruction of the course of events is the audit trail.