Member Case Study: Inspection Readiness / TMF Community of Practice Discusses Use of Metrics for Improvement

Tuesday, December 14, 2021

There was great attendance and engagement at the Inspection Readiness/TMF CoP meeting on 7-Dec-2021 during which Virendra Alate and Kirk Richter from ICON TMF Operations presented on how they have used MCC-defined TMF metrics to drive improvement in processes and TMF performance. They described their four key metrics (completeness, timeliness, quality of incoming documents, quality review compliance) and shared historic data on the trends over time. During the session, they gave examples of how the process has been changed to improve performance including, implementing automated flow of certain documents directly into the TMF and providing departments with performance feedback to assist with continuous improvement efforts.

It was a lively, interactive session with many questions from the attendees both during and after the presentation. One of the four metrics discussed in the case study is not in the current WCG-MCC TMF Metrics Toolkit v2.0 and attendees discussed whether the metric should be added to the metric set at the next review. Additionally, attendees were polled about future meeting topics and results showed two clear areas of interest – “Accurate measurement of TMF completeness” and “Practicalities of a risk-based TMF review”. If you, or your colleagues, are interested in being on a panel, or presenting on these topics in 2022, please contact the facilitator, Terry Holland.