A well-designed Data Management Plan (DMP) provides a detailed description of how to handle data under any foreseeable circumstances and establishes processes for how to deal with unplanned issues. The DMP is study specific, is considered a “living document,” and is subject to audit; therefore, it is important to understand the content requirements and rationale for its creation.
In this web seminar, we will focus on the importance of the creation of a DMP and the expected content that this document should contain. Attendees will be provided with a sample template for review.
- Identify the rationale for creation of a robust DMP
- Describe the documentation required for a DMP when utilizing both paper and Electronic Data Capture (EDC) applications
- List the components of a DMP as defined in the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP) document
- Apply standards for creating, approving, and maintaining DMPs
- Clinical Data Managers
- Project Managers
- Clinical Research
Personnel
Denise G. Redkar-Brown, MT
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Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.