Trial Master File Performance Metrics Work Group

The MCC TMF Work Group, comprised of MCC member organizations of various sizes that include Sponsors, CROs, eTMF Vendors and Consultants, worked to define a set of performance metrics that can be used to assess the timeliness of filing, document quality, TMF completeness and effectiveness of an organization’s TMF process. The recently updated MCC TMF Metric Toolkit v2.0 contains additional advanced metrics, metric selection tools and a detailed Implementation Guide.

Meeting Schedule

The work group has moved into the Implementation Support stage of the metric set life-cycle. Online meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing the metric set. Registration links are available on the Upcoming Meetings Webpage in the MCC Members Portal.

Team Output:

MCC TMF Metric Toolkit v2.0

Component Purpose
At-A-Glance Short document to describe the purpose of the MCC TMF Metrics Toolkit v2.0 and updates since v1.0
MCC TMF Metrics Toolkit 2.0 Overview (Recorded Webinar and Slides) To provide an overview of purpose of the metrics and how to use the toolkit
MCC TMF Metric Implementation Guide To provide guidance on how to implement and use the MCC TMF metrics
MCC TMF Artifact Mapping Tool* To capture expectations of who is responsible for uploading/filing artifacts and when they are due
MCC TMF Assessment Tool* To capture TMF assessment results, calculate metrics and track numbers of queries
MCC TMF Metrics and Process Maps Workbook* To define each metric. Includes purpose, recommended usage, target glossary and process maps
Metric Selection Tools:
Tool 1: Metrics to Data Elements* To determine data elements needed to calculate specific metrics
Tool 2: Data Elements to Metrics* To determine metrics available with a given set of data elements
Tool 3: Issues to Metrics* To determine recommended metrics and data elements for particular issues

*Each tool has a short associated “How-To-Use” Recorded Webinar.

MCC member organizations can download the MCC TMF Metric Toolkit v2.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.

Team Explored:

  • How well the TMF process is being executed and managed throughout a study’s start-up, conduct and closeout.
  • How well the TMF process is being performed across studies.
  • Criteria that defines an “acceptable level” of performance.
  • Establishing a “basic” metric set that can be used in paper and/or eTMF programs and a more “advanced” metric set that can be adopted by organizations with more advanced eTMF systems and experience using TMF metrics.

MCC Membership Information

This is a member-only group. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland or call 317-622-0266, ex.108. Contact Linda Sullivan to discuss additional study team-related details. Return to Work Group List

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Employees of MCC member organizations are invited to join the MCC Trial Master File LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.