Data Management/Validation Plan
A Data Management/Validation Plan in a clinical trial outlines the systematic approach for collecting, verifying, and maintaining accurate and reliable data. It includes strategies and procedures to ensure the quality and integrity of the data collected during the trial. This plan typically covers data entry, data validation, discrepancy management, data storage, and the roles and responsibilities of the data management team. It’s a crucial component of clinical research to ensure that the trial results are valid, credible, and can be used for regulatory submissions and scientific analysis.
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