Sponsors are expect to maintain a complete set of essential documents as required by federal and international regulations for evaluation by the regulatory bodies. Many of these documents originate at the trial sites, labs, and other locations outside the sponsors’ control.

The GCP predicate rules are clear in that the TMF must be kept up to date, with documents placed in the TMF in a timely manner, as Regulation 31A (3) of SI 2004/1031 states: ‘The master file shall at all times contain the essential documents relating to that clinical trial’.

Therefore the eTMF must support the establishment and maintenance of expected documents at the study, country and trial level with notification and reporting mechanisms that inform trial stakeholders when documents are required, available, changed, reviewed, signed, and read.

The Itrica eTMF includes a Milestones module that allows the TMF Manager the ability to assign due dates to essential documents along with comprehensive reporting tools to ensure the necessary stakeholders are aware and have read the required documentation.

Key Benefits

Sponsor/CRO

• Simple to administer over multinational/multilingual studies
• DIA v2 Reference Model compatible
• Document lifecycle management and version control
• Increased efficiency by ensuring all trial stakeholders have access to the correct documents
• Part 11 Compliant

Clinical Site

• Direct access to Trial and Subject documentation via Web Browser on and device
• Simple and intuitive Windows Explorer folders look-and-feel
• Automatic notification of essential documentation

Key Features:

Configurable

• Manage any document of any type and format in any folder structure as desired per trial
• Configure document lifecycles and user access permissions
• Control who can create, change, review, publish and read the documents

Searching

• Full-text search capability on document titles and content

Document Management

• Part 11 compliant eSignatures
• Assign milestones and due dates to essential documents
• Automatically route documents to correct folders based on metadata tagging

Robust Reporting Out-of-the-box

• Automatic notifications when documents are added, changed, and transition through the documents lifecycle
• Read receipts for tracking site acknowledgements

Audit History

• Full audit trail of who, what, where, and why documents are added, changed, signed, and read