Overview
The Egnyte eTMF (Electronic Trial Master File) app offers flexible artifact/document filing and clinical trial management capabilities, which fully align with the DIA TMF Reference Model(v3.1.0). The TMF Reference Model provides standardized taxonomy, metadata and definitions of TMF content. The app comes with complete and pre-configured artifacts required for each filing level.
Artifact Configuration
- To view the required and optional artifacts for each filing level in a study, go to Configuration from the home screen. All required or 'Core' artifacts for each filing level, according to the TMF Reference Model, have been pre-selected:
- You can manually add additional or Recommended artifacts to any filing level by selecting them:
- You can also remove required or Core artifacts from any filing levels by 'unselecting' them. The system will ask for confirmation when unselecting Core artifacts.
- Add any custom artifacts that are not present in the DIA reference model v3.1 by selecting Add artifact.
- Indicate whether any artifacts will contain unblinded content by checking the box in the Unblinded column. This will require users to have Filing Level Unblinded Access in addition to their other permissions in order to access documents filed to that artifact