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

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

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