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Theo FDA: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf
The CDM process, like a clinical trial, begins with the end in mind. This means that the whole process is designed keeping the deliverable in view. As a clinical trial is designed to answer the research question, the CDM process is designed to deliver an error-free, valid, and statistically sound database. To meet this objective, the CDM process starts early, even before the finalization of the study protocol.
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