Documents

The Documents section is the central repository for all clinical trial documents in their original digital format, including Digital Signatures where applicable. It also includes records or documents converted from other formats, such as paper documents, images converted to PDFs, videos, and recordings related to trials.

Here, users can configure and store essential documents about clinical trials, view and edit document attachments, manage security privileges, import and export documents and their metadata, and share them with other users.

To ensure eTMF Completeness, users can track the progress of documents from collection to finalization. The application also allows users to post Questions and Answers and generate FAQs for further insights.

The documents are then subjected to Quality Controland Quality Review checks as per FDA regulations. Users can access the Documents Viewby clicking the Documents icon in the menu bar on the left-hand navigation pane.