Risk-based
TMF Quality Control

The Trial Master File (TMF) is the collection of essential documents that demonstrate the Sponsor's compliance with the applicable regulations and guidelines, as well as the quality and validity of the clinical trial data. The TMF also serves as a source of information for audits and inspections by regulatory authorities or other authorized parties.

A risk-based approach to TMF Management allows the Sponsor to prioritize the most critical and relevant aspects of the TMF and allocate resources accordingly.

A risk-based approach also helps the sponsor to adapt to changing circumstances and address emerging issues in a timely and proportionate manner.

Regular quality control (QC) of the TMF is an essential part of the Sponsor Oversight process. QC activities ensure that the TMF is complete, accurate, consistent, and up-to-date, and that any gaps, errors, or discrepancies are detected and resolved promptly.

QC also verifies that the TMF reflects the current status and progress of the clinical trial and complies with the protocol, the functional plans, and the applicable standards and regulations.

This Template already includes many examples of the criticality assessment and auto-calculated risk scores. Thus, you have a good starting point for your risk-based TMF QC.

  • User Group

    Professionals Involved in TMF Quality Control


  • Format

    Microsoft Excel


  • Content

    • Based on the DIA Reference Model v3.3
    • Define the Criticality per Document
    • Define the Document Status
    • Accept or Deny the Risk per Document
    • Define your Quality Tolerance Limits
    • Define your Risk Mitigation

  • Benefits

    •  Documentation for your risk-based TMF Quality Control Plan
    • Documentation for your risk-based TMF Quality Control Process

With a risk-based TMF Quality Control, you will

  • Ensure the Completeness, Accuracy and Timeliness of your TMF documentation throughout the Clinical Trial Lifecycle
  • Identify and address potential Issues or Gaps in your TMF before they become critical or affect your Inspection Readiness
  • Reduce the Cost and Effort of conducting full TMF Reviews by implementing ongoing Quality Checks focused on Critical Documents
  • Align your TMF Quality Control activities with the ICH-GCP E6(R3) guidelines and the risk-based Quality Management Principles
  • Enhance the Transparency and Accountability of your TMF Stakeholders and improve Collaboration across Sites, Service Providers and Sponsor
Created with