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What Is Audit Trail? |
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Answer» It is the data which SHOWS that the STUDY was CONDUCTED according to the PROTOCOL. It tells the who, when and why of the entry/changes in data. It is the also defined as the "DOCUMENTATION that allows reconstruction of the course of events" according to SCDM (Society for Clinical Data Management). It is the data which shows that the study was conducted according to the protocol. It tells the who, when and why of the entry/changes in data. It is the also defined as the "Documentation that allows reconstruction of the course of events" according to SCDM (Society for Clinical Data Management). |
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