Metrics Champion Consortium
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May 2020

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  Important News

 

COVID Question of the Week…
What stage are you in with reviewing study level risks on your clinical trials?

CLICK HERE TO RESPOND
[Results shared at next meeting.]
 

 

MCC COVID-19 Member Forum Discussing Remote Monitoring, Virtual/Remote Patient Visits and Restarting Clinical Trials
MCC launched a knowledge sharing group to allow MCC member organizations to share information and to support each other in running clinical trials during the COVID-19 pandemic. The weekly discussions are summarized in a 24-page document entitled, Clinical Trial Operational Challenges During COVID-19 Pandemic - MCC Member Knowledge Sharing Discussions available to members in the member portal. The following topics are included in the document:

  • Protocol deviations and protocol amendments
  • Informed consent form amendments
  • Inspection Readiness
  • Patient Communication         
  • Missing data and/or modified visits
  • Risk management & control
  • Minimizing On-Site Monitoring Visits
  • Centralized Monitoring
  • Remote/Virtual patient visits
  • Using local labs
  • Regulatory Inspections
  • Re-starting Clinical Trials
  • Lessons learned        

To learn more about the MCC COVID-19 virtual discussion group and knowledge portal, please visit the MCC COVID-19 Operational Challenges Knowledge Sharing Group page or contact MCC.
 

MCC Announces the Release of Cardiopulmonary Process Metric Toolkit v2.2 (ABPM, ECG, and Spirometry metrics)
The MCC Cardiopulmonary Process Metric Toolkit v2.2 is now available for MCC member organizations to download from the portal. Thank you to all who provided input and feedback as we carried out this update. The toolkit includes “core” metrics that are applicable to the set-up, conduct and oversight of ambulatory blood pressure monitoring (ABPM), electrocardiogram (ECG) and spirometry services in clinical trials. Additionally, the toolkit included ABPM-, ECG- and spirometry-specific metrics. The update includes the following modifications:

  • Consolidation of all metrics into one metric workbook – comprising the core metrics, and ABPM-, ECG- and Spirometry-specific metrics.
  • Metric “Core 3” has been split into two metrics – one measuring the proportion of sites where equipment was shipped on time and another measuring the proportion of sites where equipment is reported as having an error. In the original metric, the measurement was for the proportion of sites where equipment was received on time and members agreed that this was very challenging data to collect.
  • Performance targets updates for the ECG metrics 1a, 1b and 1c, and the example formula corrected for 1b and 1c.
  • The glossary has been added to the metric workbook - similar to other MCC metric sets.
  • Metric selection tools and implementation support tools have been developed

The changes were reviewed and accepted by MCC members in March 2020. Please visit the MCC Cardiopulmonary Process Metrics Work Group page for additional information.
 

MCC Relaunching eCOA Process Metric Work Group to Update Metric Toolkit – Initial Meeting Moved to July 15th [Meeting Open to Public]
PhoneTestImageThe use of eCOA methods to collect clinical trial data is rapidly expanding – especially during the COVID-19 pandemic. MCC members have 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 EDT, after the initial meeting in July. The first meeting is open to the public.

Tuesday, 15-July-2020 10am EDT [open to public]

Review 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
     

MCC Launching New Inspection Readiness / TMF Community of Practice Group on June 11th with Presentation COVID19 – Are you ready for remote inspections? [Meeting Open to Public]
MagnifyGlassPeopleThe 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.

Thursday, 11-June-2020 10am EDT  [open to public]

COVID19 – Are you ready for remote inspections?
Sholeh Ehdaivand, President & CEO, LMK Clinical Research Consulting 

During this session, we will explore the likely change in regulatory inspections brought about by the pandemic. Some regulatory authorities already carry out part of the inspection remotely e.g. with a remote TMF review. We expect this move to more remote inspections to accelerate due to the pandemic. Maybe this will become the new normal. Are you ready for what it entails? This Community of Practice will meet on a quarterly basis to discuss specific topics. Additional information about the new group can be found by visiting the MCC Inspection Readiness/TMF Community of Practice page.


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  Member News

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

MCC thanks the following members for their renewal:

  • Pharma Initiatives
  • Pure Health Consulting
  • Vertex Pharmaceuticals

Working group icon

  Work Group

MCC Compliance & CAPA Community of Practice Group to Discuss Categorization of Issues / Findings and Trending at May 19th meeting
Does your organization have an approach to categorization of issues and findings? Do you trend them over time? This topic will be explored at the next MCC Compliance & CAPA CoP meeting when Nancy Dynes, Consultant in Global Medical Quality Metrics, Eli Lilly and Company shares a brief presentation about the topic. Members can register for the meeting by logging into the MCC member portal and visiting the Meetings and Work Groups page or contact MCC for assistance.


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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
May 21, 2020
Jun 25, 2020*
Jul 16, 2020
eCOA Metrics
3rd Tuesday of the Month at 10AM ET
Jul 15, 2020* at 11AM**
Aug 18, 2020
Sep 15, 2020
Site Selection and Start-Up Metrics
1st Tuesday of the Month at 10AM ET
Jun 2, 2020
Jul 7, 2020
Aug 4, 2020
*Meeting date deviates from regularly scheduled frequency.
**Meeting time deviates from regularly scheduled frequency.
 

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
Jun 9, 2020
Aug 11, 2020
Oct 13, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
May 20, 2020
Jun 24, 2020*
Jul 15, 2020
Compliance & CAPA
2nd Tuesday every other Month at 11AM ET
May 19, 2020 at 11AM**
Jul 14, 2020
Sep 16, 2020
COVID-19 Operational Challenges
Every Tuesday at 11AM ET
May 19, 2020
May 26, 2020
Jun 9, 2020
Inspection Readiness/TMF
Quarterly
Jun 11, 2020
Small Sponsor Community
of Practice
Every other Month at 11AM ET
Jun 15, 2020
Study Quality Trailblazer
2nd Wednesday of the Month at 10AM ET
Jun 23, 2020
*Meeting date deviates from regularly scheduled frequency.
**Meeting time 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
Jun 10, 2020 10 AM EDT
Central Lab Metrics
Jun 16, 2020 10 AM EDT
Data Management & Biostatistics Metrics
Jun 10, 2020 11 AM EDT
Imaging Process Metrics
Jun 18, 2020 10 AM EDT
Risk Assessment & Mitigation Management Tool
Jun 17, 2020 10 AM EDT
Site Contracting Metrics
Jun 11, 2020 11 AM EDT
Vendor Oversight Finance Metric Toolkit 1.0
Jun 17, 2020 11 AM EDT
 

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

DIA 2020 Global Annual Meeting

How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should You Measure to Gain Insights? 
Monday, June 15 1:30 – 2:30 pm EDT

Session Moderator:
Linda B Sullivan, MBA
Executive Director
WCG MCC

Panelists:
Jacqueline Gough, MS
Director, Central Monitoring and Data Surveillance
Astellas, United States

Joe Kunakorn, MS
Associate Director, Oncology Risk Management for CAR-T and Apulutamide
Janssen Research & Development, LLC, United States

Charles Lawrence Liss, MS
Associate Director, Global Biostatistics
CSL Behring, United States

Barbara Novak
Systems and Process Management Lead, Clinical Operations- NA/EU
Kyowa Kirin Pharmaceutical Development, Inc., United States

For additional information, please visit https://www.diaglobal.org/Flagship/DIA-2020

MCC Clinical Trial Risk and Performance Management Summit
Sept 9-10, 2020
Virtual

Please contact MCC Executive Director Linda Sullivan or MCC Ambassador Keith Dorricott if there are topics you would like to see included for the 2020 Summit and if you are interested in participating as a presenter or panelist.

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: I saw recently that the MCC updated the Imaging Metrics set. Are there any significant changes?

A: Version 3.0, released in April 2020, represents a major update of the metric set. The MCC Imaging Process Metric Development work group used the MCC Metric Development Framework to review, revise and develop new metrics for the toolkit. They started by updating the process map and used it to highlight gaps in previous version of the metrics. The total number of metrics increased from 21 metrics to 36 metrics -  2 metrics were removed and 11 new metrics were added. The 25 metrics from v2.0 were updated to include more definition elements to bring them into line with the definition fields now used for other MCC metric sets. The new definition elements characterize the metrics to aid in the selection and use of the metrics:

  • Portfolio, study or site level designation – to ensure precise definition of the formula and potential use at the different levels.
  • Basic or advanced metric designation – Basic metrics are metrics the work group recommends all organizations consider implementing. Advanced are for a deeper dive and root cause analysis.
  • Potential Key Risk Indicator for use in Centralized Monitoring and risk control.
  • Metric Type (Timeliness, Cycle Time, Quality or Efficiency)

Additionally, each metric includes a listing of the data elements needed to calculate the metric and information about what the metric result does not tell you about performance.

The final components added to the toolkit are metric selection and implement support tools to help you select and implement the right metrics for your program.

Additional information about the metric toolkit and the work group are available at Imaging Process Metric Work Group. MCC members can download the complete metric toolkit by logging into the MCC member portal.


Education icon

  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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