What document records revisions to normal values/ranges used for medical, laboratory, or technical procedures included in the protocol?

• A. Certificates of Analysis
• B. Source Documents
• C. Updates to Normal Values/Ranges
• D. Monitoring Visit Reports

Answer: (C)

When interpreting medical, laboratory, or technical procedures in a protocol, keeping track of any changes to the reference or normal values is essential. A formal document called Updates to Normal Values/Ranges is used to record revisions to these thresholds, including what changed, why, and when it takes effect. This creates a clear audit trail and ensures all sites and investigators apply the same current values when evaluating results, which supports data integrity and participant safety. Certificates of Analysis pertain to product quality, Source Documents are the original data records, and Monitoring Visit Reports summarize monitoring activity—none of these capture revisions to the normal values used in the protocol.