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July 2020

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  Important News

Clinical Trial Risk & Performance Management vSummit – Sept. 8-10, 2020
Are you searching for a way to meet industry peers and collaborate on complex clinical trial topics? Hoping to exchange ideas with experts on managing trial risks? Working to dig deeper on performance management with your team? This Metrics Champion Consortium summit is made for you. Industry experts will share how to manage risk in a high-octane environment, assess risk during and after a pandemic, work toward centralized monitoring, decide on a remote or onsite monitoring process, maintain data quality, run risk-based audits, and manage vendors and partnerships. Don’t miss out on this chance to connect with your peers and engage around topics that will change your clinical trial practice for the better. Learn More

MCC’s Clinical Trial Optimization Podcast Show Launched July 13 – Subscribe Now!
PhoneTestImageMCC is pleased to announce the launch of the Clinical Trial Optimization a twice-monthly podcast that brings together clinical research stakeholders to exchange ideas, share knowledge, and think creatively about how to oversee, manage and optimize clinical trial planning and execution. 

Listen to Episode #1 – Laurie Halloran, Founder Halloran Consulting Group

Subscribe to the podcast show

The podcast includes discussions with clinical research industry thought leaders and practitioners about how the industry is transforming clinical research design and operations to speed up the delivery of life-changing therapies.

The podcast is aimed at clinical research professionals, including R&D executives, clinical operations managers, study managers, data scientists, quality assurance managers, biostatisticians, principal investigators, clinical research associates (CRAs), safety monitors, clinical scientists and other healthcare professionals.
 

Has COVID-19 Led to New KRIs? Record Number of Registrants Discuss the Topic at MCC Centralized Monitoring Group Meeting
RegistrationsByMeeting_ImageNearly 150 people registered for the June MCC Centralized Monitoring Community of Practice virtual meeting – a group that has seen a steady increase in participation this year.

The topic discussed at the June meeting was Has COVID-19 led to new KRIs?  The initial portion of the session included short presentations by Jianfu Zeng (Pfizer), Jennifer Campbell (CluePoints) and Artem Andrianov (Cyntegrity) who shared their learnings so far on the challenges of conducting centralized monitoring during the pandemic. KRIs such as missing visits rate, missing assessment rate, and careful monitoring of statistical power were recommended. An engaging discussion followed the presentations as people took the opportunity to exchange ideas, collaborate with their peers and think.

We would like to thank everyone who has come forward to present and participate in our Community of Practice meetings.

Additional information about the MCC Centralized Monitoring Community of Practice Group can be found on the MCC website.

This is a member-only group. Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal. 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.
 

MCC Relaunched eCOA Process Metric Work Group to Review eCOA Set-Up and Oversight – Initial Meeting Open to Public Held on July 15th
PhoneTestImageThe use of eCOA methods to collect clinical trial data is rapidly expanding – especially during the COVID-19 pandemic. MCC members requested that the consortium reconvene the eCOA Metric Work Group to discuss possible updates to the metric set.

Meetings will be held on the third Tuesday of the month at 10am, after the initial meeting in July. The first meeting discussed the following topics:

  • Work group purpose
  • Existing MCC eCOA Metrics Toolkit v2.0
  • Developments in eCOA and implications for process metrics
  • Plan for process map and metric updates and next steps

Additional information about the MCC eCOA Process Metric Work Group can be found on the MCC website.

This is a member-only group. Registration links are available on the Upcoming Meetings Webpage in the MCC Member Portal. 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.


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  Member News

MCC welcomes the following new members and thanks those for their continued membership.

MCC’s newest members are:

  • Incyte Corporation

MCC thanks the following members for their renewal:

  • Merck Sharp & Dohme

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  Work Group

MCC Compliance & CAPA Community of Practice
QualityStampImage“Should we categorize issues by type or root cause?”
During the July meeting, the group discussed the importance of connecting issue management (CAPA, root cause, preventive actions) and risk-based quality management (risk identification, risk control, mitigation)?  Linda Sullivan (MCC) showed how these two areas are closely connected and discussed the implications for managing both issues and risks in clinical trials. Linda’s presentation was based on an article published in the May Issue of Applied Clinical Trials.

The next meeting will focus on a related topic – issue and root cause categorization. As sponsors gather data for the teams identifying risks in new studies, many discover that issue and root cause data are not tracked and reported in a format that makes it easy for the risk management teams to utilize. How does your organization categorize issues and root causes? How are preventive actions shared with risk management teams to facilitate implementation with new studies? MCC members are invited to participate in the online meeting on 16 Sept 2020.

Additional information about the MCC Compliance & CAPA Community of Practice Group can be found on the MCC website  MCC Members can log onto the MCC member portal to register for the session.


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  Upcoming Meetings

MCC Metric Development Work Groups
Members work collaboratively, through structured discussions, to develop and refine metric sets and tools. Work group members are encouraged to regularly participate in monthly, 60-minute web-based meetings. On occasion members will be asked to complete structured reviews and provide feedback outside of meetings (assignments typically require 15-30 minutes to complete).

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

 Work Group
Meeting Frequency
Date
Centralized and Site Monitoring Process Metrics
3rd Thursday of the Month at 10AM ET
Sep 17, 2020
Oct 15, 2020
eCOA Metrics
3rd Tuesday of the Month at 10AM ET
Sep 15, 2020
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM ET
Aug 4, 2020
Oct 6, 2020
Nov 3, 2020

MCC Communities of Practice
Members share ideas and practical approaches to address challenges unique to these communities.

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Communities of Practice
Meeting Frequency
Date
Artificial Intelligence (AI)/
Machine Learning (ML)
2nd Tuesday every other Month at 10AM ET
Sep 24, 2020
Oct 13, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Oct 21, 2020
Nov 18, 2020
Compliance & CAPA
2nd Tuesday every other Month at 10AM ET
Sep 16, 2020*
Nov 10, 2020
Inspection Readiness/TMF
Quarterly
Sep 22, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
Aug 11, 2020
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
TBD
*Meeting date deviates from regularly scheduled frequency.
 

MCC Implementation Support Group Meetings
Members are provided the opportunity to ask questions and share experiences related to implementing specific metric sets or tools at quarterly web-based meetings.

To register or for more information please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

Work Group
Date & Time
Cardiopulmonary Metrics
Sep 29, 2020 10AM EDT
Central Lab Metrics
Oct 8, 2020 10AM EDT
Data Management & Biostatistics Metrics
Sep 29, 2020 11AM EDT
Imaging Process Metrics
Oct 7, 2020 11AM EDT
Risk Assessment & Mitigation Management Tool
Sep 30, 2020 11AM EDT
Site Contracting Metrics
Sep 30, 2020 10AM EDT
Vendor Oversight
Oct 7, 2020 10AM EDT
 

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2020.

WCG-MCC Clinical Trial Risk and Performance Management Virtual Summit
Live Sessions 8-10 September 2020 - Access to pre-recorded presentations beginning 26 August

Learn More


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  Ask the Experts — MCC Answers Your Metric Questions

Meet The Experts

  Keith Dorricott
  MCC Ambassador and Director
  Dorricott Metrics and Process Improvement, LTD




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

Q: My organization is implementing a cloud-based Quality Management System (QMS) to help us manage audits, quality issues etc. Does the MCC have a standard approach to categorizing issues that we could use?

A: MCC does not currently have a set of standard categories for issues. However, we have recently launched the Compliance & CAPA Community of Practice and at the meeting on July 14th, Linda Sullivan presented on “Connecting Issue and Risk Management”. The plan for that Community of Practice is to discuss categorization of issues at the September meeting. It is a fascinating area and, if done right, can be extremely powerful in pulling together different parts of the QMS and making use of disparate data sources. Some regulators, in particular the MHRA, report annually on their inspection observations by category. Their categories are focused on the process where the inspection observation occurred. And this raises the question of whether the categorization should be for the issue itself, or for its root cause(s). Both have value – see the table below.

Issue
Root Cause
Monitor trends by issue type / process
Monitor trends by root cause
Input into risk-based quality management (RBQM) – what issues occur frequently and should be included as risks?
Input into risk-based quality management (RBQM) – if linked with risks that are prioritized for mitigations, root causes would help in developing effective mitigations.
Valuable for process owners to monitor to show the health of the process
Valuable for strategic leaders to monitor to indicate fundamental weaknesses
Input into process improvement – what are the process areas that need further process improvement?
 

By standardizing categories for both issues and root causes and then harmonizing across different issue types (e.g. quality issues, audit findings, inspection observations, protocol deviations) it is possible to develop a powerful tool for monitoring the health of the processes and systems. And this can be used to determine where improvement efforts need to be focused and later on, whether those improvement efforts have been successful.


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  Education

Unlock the Power of Your Data to Dramatically Improve Clinical Research Efficiency
Organizations have to do more than just collect data – they have to understand what the data is saying. MCC’s eLearning Institute is the tool every organization needs to give employees that needed knowledge.

The unique eLearning education program allows professionals to gain a solid metric knowledge foundation with a flexible format that can be customized to meet your needs. The MCC eLearning Institute:

  • Teaches industry-leading metric understanding and risk management concepts
  • Provides a self-study, on-demand learning program to accommodate your busy schedule
  • Accommodates several learning styles
  • Allows you to pause and pick up at a later time
  • Can be easily customized and deployed on your organization’s Learning Management System

Click HERE to learn more about the entire MCC Learning Institute and on the “Mastering Performance Metrics” eLearning Program:

MCCe201: The Elements that Make Metrics Effective

MCCe202: Developing Effective Metrics Using a Structured Process

MCCe203: Effective Metric Visualizations to Gain Valuable Performance Insights


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  MCC Membership and User Accounts

Access to MCC metric sets, tools and other assets are limited to employees of MCC member organizations. Please visit the MCC website or email MCC Membership Director Terry Holland for membership information.

Setting Up User Accounts to Log onto Member Portal
If you work for a MCC member organization, you are welcome to set up an individual user account to take advantage of the benefits MCC Membership offers. Click HERE to start the process.

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Join the MCC LinkedIn Group to learn about industry performance metrics and stay informed of new developments.

 
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Metrics Champion Consortium,  300 N. Washington St.,  Falls Church, VA 22046,  United States 
Phone (617) 948-5100 | Toll free (866) 219-3440

© 2020 Metrics Champion Consortium

 
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