Announcing New TMF Metric Toolkit that Improves Inspection Readiness

Wednesday, June 21, 2017

Chicago; June 21, 2017 –

Metrics Champion Consortium (MCC) announced today the release of its Trial Master File Metric Toolkit during a poster session at the Drug Information Association Annual Meeting. “The Importance of Measuring TMF Health for Continuous Inspection Readiness” was presented by Dawn Niccum, inSeption Group (formerly Endocyte); Sholeh Ehdaivand, LMK Clinical Research Consulting; and Keith Dorricott, MCC Ambassador.

“Over the last few years, our members have been investing a great deal of resources in updating and improving their TMF filing processes to meet regulatory expectations,” said MCC President, Linda Sullivan. “We are pleased to release the MCC TMF Basic Metric Toolkit which includes a set of core metrics and supporting tools that enables any sized organization to use the widely-adopted Plan-Do-Check-Act iterative management approach to manage and improve TMF inspection readiness.”

The MCC Trial Master File (TMF) Toolkit provides a comprehensive approach to enable organizations to apply Plan/Do/Check/Act to the TMF management process. Specifically, the following are included in the toolkit:

  • MCC TMF Artifacts Mapping Tool (based on the TMF Reference Model v3)
  • MCC TMF Basic Metric Set (includes metric definitions, performance targets and reporting frequencies)
  • MCC TMF Assessment Tool (includes recommended TMF assessment schedule)
  • MCC TMF Implementation Scenario Guide

The toolkit provides sponsors with the means to update their TMF filing and oversight approaches to align with regulatory expectations. Used together, these tools and metrics reinforce the importance of establishing expectations, measuring actual performance and fixing the problems that arise.

“While most organizations utilize the TMF Reference Model as a starting point, the MCC TMF Metrics Work Group participants recognized the need to expand upon the TMF Reference Model to establish role-specific and milestone-/event-based expectations in order to generate meaningful metrics,” explained Sullivan. “This is where the toolkit’s components help by providing a comprehensive way to measure and help manage the TMF.”

For additional information, please visit the TMF Hompage.

About Metrics Champion Consortium (MCC)

MCC—a trusted partner in the clinical trials industry—identifies what to measure, how to assess the crucial components of what is changing and how the industry is responding to address these changes to make improvements. MCC continually brings you new insights into the leading trends within the industry. For more information about MCC metric sets and tools, metric education programs and how you can participate in MCC work groups, please visit

Linda Sullivan