rt_gcp_research

Basics of Good Clinical Practices for Clinical Research Coordinators

Objective: To introduce, apply, and analyze internationally accepted guidelines for clinical research on humans, including those of the International Conference on Harmonization (ICH) and the Food and Drug Administration (FDA).
Selected Topics: Focus on Primary CRC Responsibilities, Document Management and Ethics
Exercise in Source Documentation and Adverse Events
Exercise in Study Conduct
Guidelines for Trial Document Completion and Acceptance
Audience: Clincal research coordinators