The Egnyte eTMF app has an “Import” functionality where the user can bring their TMF data from completed studies, typically stored in other eTMF applications, into the Egnyte system. The import process is done using an XML standard (Exchange Mechanism Standard/EMS) created by the same group who developed the eTMF Reference Model.
Exchange Mechanism Standard (EMS)
When a TMF is exported to an XML file based on the EMS, the following document metadata is captured:
- Site/country/trial info
- File name
- File checksums
- Metadata and audit details
Once the import file (from the external system) is created, the user will follow a four-step process to complete the import:
- Upload import file
The user can upload the import file into the Import screen in the Egnyte eTMF app.
The Egnyte system will perform a scan of the import file to verify that there are no critical errors which will cause the import to fail.
Once the initial verification is completed and there are no errors in the import file, the user can start the actual import process.
Once the import is completed, the user can choose to accept or reject the import.