Is It Time To Switch Your Paper Trial Master File To An eTMF?

Investigators/institutions and sponsors of a pharmaceutical clinical trial are required to maintain a Trial Master File (TMF), a collection of essential regulatory documents. The TMF enables scrutiny, by independent auditors and regulatory authorities, of the conduct of a trial and the quality of the data produced. These essential regulatory documents are critical to substantiate adherence to GCP standards and regulatory compliance by the trial's investigators/institutions and sponsors.

With over 50 categories of documents to track for numerous individuals spanning the three major phases of a trial, a paper-based TMF represents a tremendous financial and governance risk to all parties invested in a trial's outcome. Results of a successfully executed trial can be substantially delayed because of problems with the TMF.

Challenges with a paper-based TMF

• Extremely difficult to ensure regulatory compliance throughout all phases of a trial
• Costly and labor-intensive to manage and maintain
• Does not track the status of required document submissions or follow up action items
• Requires auditors and reviewers to access hard copies in person
• Prohibits analysis and mining of the data
• Substantially increases risk