Data Integrity and Electronic Trial Master Files
Ensuring data integrity is foundational to the credibility of clinical trial outcomes and pharmacovigilance processes. This session focuses on maintaining the reliability, accuracy, and traceability of clinical and safety data, particularly in the context of electronic systems such as the electronic Trial Master File (eTMF). Participants will explore current best practices for implementing ALCOA+ principles, managing audit trails, and securing electronic records. Emphasis is placed on system validation, user access controls, and data lifecycle management. Real-world scenarios will demonstrate how lapses in data integrity can compromise trial results and lead to regulatory actions. Guidance on audit readiness, compliance with 21 CFR Part 11, and integration of eTMF with other digital platforms will be discussed.
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