Module 12 Presentations

• 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 and where available , the Statistical Analysis Plan Data Management Planning and Plans (DMP)

The Organisation for Professionals in Regulatory Affairs