TMF Metrics

February 2, 2023

There are several key metrics and KPIs (Key Performance Indicators) when working with the Trial Master File (TMF) that are important to track and monitor to ensure that the trial is progressing as planned and that the TMF is complete, accurate, healthy, and easily accessible. Some of the most important metrics to consider include:

  1. Document completeness: This metric measures the percentage of required documents that have been submitted to the TMF and checks if all the necessary information is present in the documents.
  2. Document accessibility: This metric measures the ease of accessing the documents in the TMF, both in terms of physical accessibility (if the TMF is paper-based) and electronic accessibility (if the TMF is electronic).
  3. Audit readiness: This metric measures the readiness of the TMF for an audit by regulatory authorities, ensuring that all required documents are present and that the TMF is organized in a manner that is easy for the auditor to review.
  4. Compliance with regulatory guidelines: This metric measures compliance with regulatory guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, ensuring that the trial is conducted in accordance with these guidelines and that the TMF is aligned with regulatory requirements.
  5. Query resolution time: This metric measures the time it takes to resolve any discrepancies or questions related to the documents in the TMF, ensuring that any issues are resolved quickly and effectively.
  6. Document accuracy: This metric measures the accuracy of the information contained in the documents submitted to the TMF and ensures that all the information is accurate and consistent.
  7. Timeliness of document submissions: The timeliness of document submissions is critical in ensuring that the TMF is complete and up-to-date. This metric measures the time between when a document is generated and when it is submitted to the TMF.

All of the key metrics above represent important actions you can track to establish the foundation of a healthy TMF. Through continuous verification of the expectations for your study (whether SOPs or regulatory requirements), issues can be addressed before they spiral out of control. Over time, as you review your TMF metrics, the health of your TMF steadily improves. TMF Metrics also improves your mental health by preventing last-minute surprises.

These key metrics and KPIs are important in ensuring that the TMF is complete, accurate, easily accessible, and in compliance with regulatory guidelines. Monitoring these metrics helps to identify areas where improvement is needed and helps to ensure that the trial is progressing as planned.