What is a Master Record and why is it controlled?

• A. A summary report of results.
• B. The complete set of documents that define the study; controls ensure traceability and reproducibility.
• C. The equipment maintenance log.
• D. The funding agreement.

Answer: (C)

A Master Record is the complete, authoritative set of documents that define a study and how it was conducted. It includes the protocol (and any amendments), SOPs, raw data, final reports, and essential correspondence that show exactly what was done and how decisions were made. This collection is controlled to preserve traceability and reproducibility: only authorized people can make changes, each change is dated and versioned, an audit trail is maintained, and the records are stored securely and are accessible for review. This level of control ensures the study can be reconstructed and inspected reliably, which is why the Master Record is central to compliance. An equipment maintenance log, while important for equipment upkeep, does not define the study or its data, so it isn’t the Master Record.