Release Date: June 8, 2023
We are excited to announce the fourth release of the Egnyte eTMF app. In this release (v.4.0), we are introducing an importing function which allows CROs and sponsors to bring their TMF data in completed studies, typically stored in other eTMF applications, into the Egnyte eTMF system. The import process is done using the latest exchange mechanism standard (EMS) defined by the same group who developed the eTMF Reference Model.
Import Dashboard
In this release, an “Import” tab is added to the Study Configuration screen. Users can upload the import file (in the EMS XML format) and start the import process.
Import Errors and Warnings
Prior to the start of an import, the system will perform a verification check/scan on the import file for errors or issues that might cause the import to fail. The system will also display the errors and warnings found during the import. Examples of these errors and warnings are:
Errors:
- ‘File does not follow EMS schema format’
- ‘Country code is not an ISO-3166 Alpha-3 code’
- ‘{0} in the import file contains disallowed characters’
Warnings:
- ‘Redundant info on trial level: Country and site IDs will be ignored on trial-level document’
- ‘Redundant info on country level: Site IDs will be ignored on country-level document’
- ‘Study code inconsistency: Study ID in the import file differs from actual study’
Importing Custom Artifacts
In this release, we have defined and built in rules in the system to import external artifacts that do not conform to the Reference Model (for example, artifacts that are not associated with any milestones, artifacts that are filed at incorrect levels according to the Reference Model, etc.) To import these “custom” artifacts, the new importing feature automatically look for alternative locations to store them in the Egnyte TMF structure.
Available Options Post Import
After an import is completed, users can do the following options:
- Generate a report showing the following events:
- import created
- import confirmed
- import rejected
- import failed
- import succeeded
- Redo an import (if there were too many errors found during the import)
- View the metadata of the imported files from the eTMF Viewer screen