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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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Clinical Quality Management

The Division of Microbiology and Infectious Diseases (DMID) requires supported clinical research sites to develop a Clinical Quality Management Plan (CQMP). A CQMP serves as a management tool for sites to internally evaluate and document the performance of protocol-related procedures and processes. DMID developed CQMP guidance and sample tools to assist sites in meeting the requirements for the development and implementation of a CQMP.

DMID Clinical Quality Management Policy

Guidance: CQMP Guidance and Tools—This site includes

  • CQMP Guidance
  • CQMP Fact Sheet
  • CQMP Instructional Template
  • Sample Chart Audit Tool
  • Sample Regulatory File Review Tool
  • Sample CQMP Summary Report Tool
  • Sample Annual CQMP Evaluation Tool

Related Links

Last Updated February 20, 2014