What is the purpose of an audit trail in IH data management?

• A. Documenting data changes is optional
• B. Documenting who accessed or changed data and when
• C. Calibrating instruments
• D. Scheduling sampling

Answer: (B)

An audit trail in IH data management is about recording who accessed or changed data and when. This creates traceability and accountability for every data action, which is essential for ensuring data integrity. In practice, an audit trail captures details such as the user identity, the exact time, what action was taken (entry, modification, deletion), and often the before-and-after values. This helps investigators verify results, detect errors or tampering, and demonstrate compliance with regulatory and quality standards like 21 CFR Part 11 or ISO 17025.

Why the other ideas don’t fit: instrument calibration is about ensuring measurement accuracy, not who handled the data; scheduling sampling is about planning activities, not recording data provenance. The key purpose of an audit trail is to document access and changes to data to maintain trustworthiness and accountability in the data record.