Objective: The workshop aims to provide participants with a comprehensive understanding of Electronic Trial Master File (eTMF) systems and their role in clinical research documentation management.
Agenda:
- Introduction to eTMF
- Overview of Trial Master File (TMF) and its evolution to eTMF
- Importance of eTMF in modern clinical research
- Key Components of eTMF
- Document management: Organizing and categorizing trial documents
- Version control and document tracking
- Audit trails and electronic signatures
- Regulatory Compliance
- Regulatory requirements for eTMF systems (e.g., FDA 21 CFR Part 11)
- Ensuring data integrity and security
- GCP compliance and inspection readiness
- Implementing eTMF Systems
- Selection criteria for eTMF software vendors
- Integration with other clinical trial systems (e.g., EDC, CTMS)
- Best practices for system implementation and user training
- Hands-On Training
- Interactive sessions demonstrating eTMF functionalities
- Practical exercises for document upload, versioning, and retrieval
- Troubleshooting common issues and system maintenance
- Case Studies and Examples
- Real-world examples of successful eTMF implementation
- Challenges encountered and lessons learned
- Case studies illustrating the benefits of eTMF in clinical trials
- Future Trends and Considerations
- Emerging technologies and trends in eTMF
- Role of eTMF in decentralized and virtual clinical trials
- Anticipated regulatory changes and their impact on eTMF systems
- Q&A and Discussion
- Open forum for participants to ask questions and share experiences
- Facilitated discussion on challenges, opportunities, and best practices in eTMF management
