Introduction to eTMF

The Electronic Trial Master File (eTMF) application functions within eClinical as a storage repository and management center for clinical trial files.

The application provides users with quality checks, granular access control, and approval workflow to enable integrity, timeliness, and accuracy by enhancing standardized file management procedures. Thus, with the eTMF application, users can organize the collected clinical trial files more easily and effectively.

Sources of eTMF documents

The files in eTMF can originate from other eClinical applications (CTMS, EDC, and others), S3 platform, local PC, and by copying existing files in eTMF.

Figure 1. Sources of eTMF documents

• Other eClinical applications. The documents stored or generated in other eClinical applications can be uploaded into eTMF.

• S3 platform. Users can use the TMF import function to upload TMFs from the S3 platform to eTMF in batches.

• Local upload. Users can manually upload files via File Management or via Essential Documents functionality.

• File copying. eTMF provides users with the ability to copy files to a different location within the eTMF application.