The 4th Annual WCG MCC Clinical Trial Risk and Performance Management Virtual Collaborative vSummit Receives High Marks!

Thursday, October 21, 2021

The MCC Risk and Performance Management Virtual Summit had a record number of attendees view presentations and participate in “virtual” mini-workshops and discussion groups 28-30 September 2021. We’ve received very positive feedback about the topics covered as well as the experience of participating in virtual groups that used white board technology to gather input and share knowledge.

The keynote presentation ICH E6(R3) Guideline for Good Clinical Practice – An Important Global Standard for Clinical Trial Conduct featured M. Khair ElZarrad, Acting Director – Office of Medical Policy CDER | US FDA sharing his views on the following topics:

  • Rapidly evolving evidence generation ecosystem
  • ICH-E6(R3) development approach
    • ICH E6(R3) development strategy
    • Analysis of public input conducted by the Expert Working Group
    • Stakeholder engagement
  • Published E6(R3) introduction and principles
    • Overview of the draft introduction
    • Overview of the draft principles
  • Expert Working Group web-conferences – May 18 & 19
  • Lessons learned and moving forward

At the end of his presentation, he answered questions posed by Summit attendees. Summit participants can download his presentation and view a recording of the entire 1.25-hour session by logging in the MCC Summit event portal.

Throughout the three-day event, participants had opportunities to “collaborate” in virtual mini-workshops and discussion groups that covered a variety of quality-by-design / risk-based quality management, process improvement and vendor oversight topics.


  • Risk-Based Quality Management Critical Thinking Workshop — What Can Go Wrong?
  • The Value of and the Approach to a Retrospective Risk-Based Quality Management Analysis
  • How to Define Critical Processes and Critical Data
  • Identifying Common Risk Factors to Support Tiering Sites for Monitoring
  • Oversight of RBQM with a CRO
  • IT System Selection – Don’t Make These Mistakes
  • Using Metrics to ID Issues and Drive Improvement Activities

Discussion Groups

  • Managing Risk Across a Portfolio of Studies
  • RBQM with CROs — Best Practice Discussion
  • RBQM Documentation Approaches: Lessons Learned and Points to Consider
  • The Central Monitor Says a Risk Threshold has been Breached … Now What?
  • Linking Issues/CAPAs and Risks — Still a Challenge?
  • Selection, Implementation and Use of KPIs in a Sponsor-CRO Collaboration
  • How to Use Metrics to Gain Insights About Site Activation and Patient Enrollment
  • Decentralized Trials: How Do You Oversee, Manage New Vendors
  • How to Measure Success in a Decentralized Trial
  • From Reactive Spreadsheets to Predictive Applications: Modern Approaches to Effective Oversight

The summit closed with a panel session entitled, Quality Tolerance Limits (QTLs): Why Are They So Challenging? And How Can MCC Help? During the live, virtual session, representatives from MCC’s QTL sub-team, Maureen Cunningham (United Therapeutics Corporation), Keith Dorricott (MCC QTL sub-team facilitator), Kristin Stallcup (Labcorp) and Steve Young (CluePoints) shared their perspectives on the challenges organizations are facing with QTL implementation and summarized some approaches discussed in the MCC group and shared with the MCC Centralized Monitoring Community of Practice earlier this year.

A summary report will be provided to attendees later this year. For additional information about the MCC Summit, please visit