e-FORM

e-TMF (Trial Master File) is a solution implemented integrated within e-FORM or in a standalone version for managing clinical studies.
It ensures compliance with the TMF Reference Model, a widely used and consolidated reference model or any other tailored model.
Here are the characteristics:

• Compliance with the TMF Reference Model
• Differentiated access to Zones based on privileges
• Ability to customize the reference model to handle specific situations or adopt a completely new one
• Secure uploading of files/documents to a dedicated and protected area, inaccessible via HTTP/HTTPS
• Support for document versioning and associated metadata
• Ability to search for and download files/documents
• Security of access
• Tracking of significant actions (logs) and user modifications (audit)
• Full integration with the e-FORM 5.0 clinical study management system
• Metrics and reporting

The advantages of e-TMF include:

• A single repository, where all users share the same, up-to-date set of files/documents, eliminating paper and digital copies.
• A standardized system with controlled access, adopting the TMF Reference Model and ensuring documentation is shared only with authorized personnel, stored in a secure, centralized area inaccessible via HTTP.
• Real-time updates during the trial.
• Ensuring inspection readiness.
• Classification according to the TMF Reference Model.
• The ability to search for documentation by Zones/Sections/Artifacts and other metadata.
• Quality Review (QR) of the documentation.
• Tracking of all significant actions performed on the Trial Master File, recorded in the system's Event Log and Audit Trail.
• Electronic signatures to guarantee document integrity.