ABSTRACT
Data management plans (DMPs) are created by clinical data management (CDM) to document how data management for a given study was carried out. Data management plans are not required by any law or regulation but are so common across biopharmaceutical companies that they are considered an auditable document. After looking at standard operating procedures (SOPs) and training records, an auditor investigating clinical data management practices will typically ask for the data management plan for a study being reviewed. This chapter discusses what is typically found in a DMP and how to use these documents ef—ciently.
