TMF Reference Model & eTMF Exchange Mechanism Standard
The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. This session will give an update on the model and exchange mechanism standard, along with issues and future trends.
- TMF Reference Model v3.1.0
- Overview of the standard
- Project overview and next steps
- eTMF Exchange Mechanism Standard (eTMF-EMS) v1.0
- How does it work?
- Use Cases:
- Final eTMF transfer to sponsor from CRO for archiving
- Interim transfer of eTMF content to central eTMF or other trial management system
- Migration of eTMF content following merger and acquisition
- Migration of eTMF content following upgrade or change of eTMF system
- Long term archiving of eTMF content and associated metadata
- Solving interoperability issues
- Vendor adoption & the way forward?