Inspection Readiness/TMF Community of Practice

The MCC Inspection Readiness/TMF Community of Practice is comprised of MCC member organizations of various sizes that include Sponsors, CROs and Consultants.  Their aim is to share knowledge on inspections and best practices on Inspection Readiness and to explore the use of metrics, tools and checklists.  The MCC TMF Metrics Toolkit 2.0 contains metrics that can be used to assist with Inspection Readiness – measuring the timeliness of filing, document quality, TMF completeness and the effectiveness of an organization’s TMF process.

Meeting Schedule

The Community of Practice meets every other month focusing on specific topics each meeting.  Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal.

Team Output:

MCC TMF Metric Toolkit v2.0

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 is Exploring:

  • Metrics, tools, checklists to assist with inspection readiness
  • Experiences and learnings from inspections at MCC member organizations
  • Use and implementation of the MCC TMF Metrics Toolkit v2.0
  • Leading practices on inspection readiness

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. Contact Linda Sullivan to discuss additional study team-related details. Return to Work Group List

Metric Info Sheet DOWNLOAD

MCC TMF Metric Toolkit 2.0

  • Metrics Toolkit Overview
  • Metric Toolkit Overview (Recorded Webinar)
  • Metric Toolkit Implementation Guide
  • TMF Artifact Mapping Tool
  • TMF Assessment Tool
  • Metrics and Process Maps Workbook

Metric Selection & Implementation Support Tools:

  • Tool 1: Metrics to Data Elements
  • Tool 2: Data Elements to Metrics
  • Tool 3: Issues to Metrics

Additional Resources

MCC follows the metric development process. For more information about the process:

MCC’s Metric Development Framework: Defining Metrics That Answer Key Performance Questions View white paper, Listen to podcast

Unlock the Value of MCC Metric Sets: Use MCC Metric Selection Tools to Select the Right Metrics for Your Organization View white paper, Listen to podcast

Additional white papers available here.

Contact MCC Membership Director Teresa Holland to learn how your organization can access the entire library of metric toolkits in the MCC Knowledge Portal!

Episode 11: TMF Accredited Training Program is Key To Building Your World-Class TMF with Linda Sullivan and Sholeh Ehdaivand
 

Join Our LinkedIn Community

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.