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Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records. GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability. "Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives: * Maintain data integrity and reliability. * Adhere to best practices in clinical documentation.
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