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.
1. 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:
2. You can manually add additional or 'Recommended' artifact(s) to any filing level by selecting it:
3. You can also remove required or 'Core' artifact(s) from any filing levels by 'unselecting' it. The system will ask for confirmation when unselecting 'Core' artifact(s).