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WebJun 16, 2024 · FDA: In 2013 3, the FDA Guidance for Industry, entitled: “Electronic Source Data in Clinical Investigations” defined an audit trail as: “A process that captures details such as additions, deletions, or alterations of information in an electronic record without obscuring the original record. WebFeb 22, 2024 · Although some inspections may come at a trying time, they are meant to protect the rights, safety, and welfare of human research subjects; to verify the accuracy … goddess of garlic
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