The primary purpose of maintaining anaudit trailas required under21 CFR Part 11isto preserve data integrity. According to the U.S. FDA’s regulation on electronic records and signatures, every change to electronic data must be traceable, including information about who made the change, when it was made, and what the change entailed.
TheGood Clinical Data Management Practices (GCDMP)outlines that an audit trail provides a permanent, chronological record of all modifications to clinical data. This ensures transparency and allows the reconstruction of the course of data entry and modification. The regulation aims to prevent unauthorized or undocumented data manipulation, thereby maintainingthe accuracy, reliability, and validityof electronic records.
TheFDA 21 CFR Part 11, Section 11.10(e)explicitly mandates that systems must usesecure, computer-generated, time-stamped audit trailsto independently record the date and time of operator entries and actions that create, modify, or delete electronic records. This ensures the data remains trustworthy and defensible in regulatory reviews or inspections.
Therefore, the main reason for requiring an audit trail isto preserve data integrity— ensuring that all data captured, modified, or transmitted is authentic, accurate, and complete throughout the study lifecycle.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Regulatory Compliance and Data Integrity
FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures, Section 11.10(e)
ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Integrity and System Validation
