Module 12 2019
➢ The Data Management Plan(DMP) is written to define and document the data management tasks, responsibilities, and deliverables for each clinical trial. ➢ The DMP allows the company to proactively assess and plan for the study- specific data management processes, from the receipt of the Case Report Form (CRF) to the study file archiving. ➢ The DMP is based on the clinical trial protocol, the CRF, and the CRF instructions . Data Management Planning and Plans (DMP)
The Organisation for Professionals in Regulatory Affairs
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