An Electronic Data Capture (EDC) system must include an audit trail to ensure data integrity. This audit trail records every data entry, modification, and deletion along with timestamps and user identification. It is a critical feature for maintaining traceability and accountability in clinical research, allowing for the reconstruction of data changes and ensuring compliance with Good Clinical Practice (GCP).
GCP guidelines mandate that electronic data systems used in clinical trials must maintain an audit trail to ensure data integrity and traceability.
"An audit trail is essential in an EDC system to document all data entries, changes, and deletions to maintain data integrity."
Objectives:
Ensure data integrity through traceable record-keeping.
Maintain compliance with regulatory standards.
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