Course Description

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.

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Learning Objectives

• 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

Who Should Attend

• Clinical Data Managers
• Project Managers
• Clinical Research Personnel

Instructor

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.