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Every clinical study should have prospective plans for how data will be collected, processed and stored. Likewise, every study should have defined data elements and objective evidence of how data were processed. This chapter outlines the purpose of, and regulatory basis for, such documentation in the form of a Data Management Plan (DMP). Although the clinical data manager (CDM) may not personally prepare all sections of the data management plan, he or she is often responsible for assuring that comprehensive data documentation exists.