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- What is a Trial Master File (TMF) in clinical trials?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
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What is a Trial Master File (TMF) in clinical trials?
A Trial Master File (TMF) is the structured collection of essential documents that demonstrate how a clinical trial was planned, conducted, and controlled. It provides evidence of compliance with Good Clinical Practice and regulatory requirements while supporting participant safety, data integrity, and inspection readiness.
Where is it used in clinical trials?
The TMF is used across the entire clinical trial lifecycle, from study start-up through close-out and archival. It supports sponsor and CRO oversight and serves as a primary source during regulatory inspections and audits. Documents are maintained continuously to reflect study progress and demonstrate that trial activities were performed according to approved plans and procedures.
How does Clinion implement it?
Clinion implements TMF through a defined electronic structure that aligns documents, controls, and oversight to the trial lifecycle. The system is configured using a predefined TMF model, with user roles mapped to document responsibilities. DIA is applied to support document classification and indexing, while controlled workflows manage review, quality checks, and approvals. System rules track expected documents against study milestones, and audit trails record all document-related actions. Locking and archival controls ensure the TMF is finalized and preserved in a compliant state at study close-out.
What does it look like in practice?
At the study setup, the TMF structure and user access are configured in Clinion. As trial activities begin, study teams upload documents into the TMF and route them through review and QC workflows. Reviewers approve documents electronically, and the system highlights missing or overdue items as the study progresses. Before close-out, teams confirm TMF completeness and quality, after which the TMF is locked and archived, creating a final, inspection-ready record.
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