Program Overview
This program equips clinical research professionals with comprehensive knowledge and practical skills to efficiently manage essential documents in clinical trials. Led by a seasoned industry expert, the program focuses on the fundamentals of CDM, regulatory frameworks, Trial Master File (TMF) management, and quality assurance. Participants will explore real-world case studies, engage in workshops, and gain hands-on exposure to Electronic Document Management Systems (eTMF). By the end, attendees will be prepared to optimize clinical documentation processes, ensure audit readiness, and leverage technology for streamlined compliance and operational efficiency.
Features
- Understand the importance, components, and lifecycle of Clinical Document Management (CDM).
- Apply regulatory guidelines (ICH-GCP, US FDA, EMA) to ensure compliance in clinical documentation.
- Implement best practices for managing Trial Master Files (TMF) and improving audit readiness.
- Leverage technology, such as eTMF systems, to enhance efficiency and streamline clinical document workflows.
Target audiences
- Clinical Research Professionals
- Clinical Trial Coordinators
- Data Managers
- Regulatory Affairs Teams
- Quality Assurance Personnel
Curriculum
- 6 Sections
- 22 Lessons
- 2 Days
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- Overview of Clinical Document Management4
- Regulatory Requirements and Guidelines4
- Structure of the Trial Master File (TMF)3
- Best Practices for Document Management4
- Ensuring Quality and Audit Readiness4
- Real-World Case Studies and Group Discussion3
Instructor
