A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan.

Background: The DIA Clinical Data Management Community created a committee to develop a model standard operating procedure (SOP) for writing a data management plan.

Methods: The goal of the committee was to develop a plan that could be used by industry and academic institutions. The model was based on contributed examples from committee members and their experiences with current practices and technologies.