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December 2019

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  Important News

Last Chance to Save on Your MCC Membership!
MCC’s Membership Rates will increase effective January 1, 2020. If you have been considering becoming an MCC member now is the time to act to guarantee the lower membership rates. We have extended the deadline to December 13, 2019 to request your invoice. MCC thanks those who have already locked in their 2020 renewal at the 2019 rates.

So much has changed in the past few years. MCC has become the place to meet industry peers, exchange ideas, collaborate and think. We have more metrics, tools, implementation and guidance documents, and knowledge portals for our members. We bring together clinical research stakeholders, including sponsors, CROs, partners, investigational sites, academic research organizations and consultants to collaboratively develop standardized performance metrics and associated tools that help organizations oversee, manage and optimize clinical trial execution.

Contact our Membership Director Terry Holland if you would like to take advantage of this opportunity to renew with the lower rates. If your company is not yet a member, maybe now is the time to join. Terry is happy to assist with the invoicing process and provide membership benefits and pricing.

We thank you for your continued support and participation in the MCC. It is with your help that we are the thought leader in providing performance process metrics and tools for the clinical trial industry.
 

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2020 MCC Clinical Trial Risk and Performance Management Summit – Call for Abstracts
Is your organization interested in sharing a case study about using MCC metrics and/or quality tools? Contact Linda Sullivan, MCC Co-Founder and Executive Director, or Keith Dorricott, MCC Ambassador, to learn how your organization can be a part of the 2020 MCC Clinical Trial Risk and Performance Management Summit.

The 2020 Summit will be September 9-10 in Philadelphia. This year’s Summit was a huge success with themes exploring: Tracking the Patient Engagement Movement and its Impact on Clinical Research Execution, Metric Program Implementation, Risk-based Quality Management, Risk-based Vendor Oversight and Applying Critical Thinking Skills to Utilize Metrics Effectively. Contact Linda or Keith 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. Click here to learn more.
 

Dr. Frank M. Berger to Present Protocol Complexity Case Study at January Study Quality Trailblazer Meeting
Dr. Frank M. Berger, Head of Analytics, Global Clinical Operations at Boehringer Ingelheim, will present “Case Study – Protocol Complexity” during the January 23, 2020 Study Quality Trailblazer meeting at 10AM EST.

Dr. Berger will cover the following topics:

  • What is complexity?
  • Trial complexity and protocol complexity
  • Common beliefs around trial complexity
  • Different perspectives
  • How to measure trial /protocol complexity
  • Call to action: Let’s collaborate!

MCC members can register for the January 23 meeting by visiting the Study Quality Trailblazer Work Group page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.
 

MCC Draft Imaging Metrics v3.0 Ready for Review by MCC Members
HeadScanFollowing all the discussion and review of the Imaging Metrics 2.0 in 2019, the draft metrics 3.0 are available for review.

The metrics are contained in one workbook that members can download from the MCC Imaging Metrics Work Group page located on the MCC member portal. The workbook includes a glossary of terms, a process map, change log for each metric in 2.0 and the full detail of each of the draft metrics.

Please provide your feedback on the metrics to Keith Dorricott, MCC Ambassador, by the close of business on January 15, 2020. Members will discuss the feedback at the next work group meeting on Tuesday, January 21, 2020 at 10AM EST.


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  Member News

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

MCC’s newest members are:

  • Avanir Pharmaceuticals
  • H3 Biomedicine
  • LMK Clinical Research Consulting

MCC thanks the following members for their renewal:

  • Jazz Pharmaceuticals
  • Eli Lilly & Co.
  • University Health Network

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  Work Group

Small Sponsor Community of Practice Group
MeetingTableThe December meeting started with a brief overview of the MCC TMF Metrics Toolkit 2.0, which includes short explanatory and demo videos. Sholeh Ehdaivand, LMK Clinical Research Consulting, then presented the case study “Opportunities and challenges of implementing metrics for a TMF Process at a small sponsor.”

The engaged attendees participated in positive and productive discussions. Areas discussed include:

  • The importance of taking time to set up the TMF from the start: The TMF Reference Model is not designed to be rigidly followed
  • “I don’t know what I don’t know”: The challenge of the unknown in research and that teamwork is needed across the study team to make sure the TMF is up to date
  • Start by using a small number of metrics to focus on the key performance questions: The MCC TMF Working Group has already defined these
  • eTMF systems often have huge capabilities but much of the capability is often not needed for a small sponsor eTMF rollout
  • Use of sponsor eTMF vs. use of CRO eTMF

A 43- minute recording of the presentation and subsequent Q&A and discussion is available to members on the Small Sponsor Community of Practice MCC member webpage.

The next meeting on Tuesday, February 11, 2020 will focus on the topic of vendor oversight. Maria Makarovskaya and Jacob Ehrlich from Pure Health Consulting will lead a discussion about “Working with CROs – Small Sponsor Edition: How do you do vendor oversight?” MCC members can learn more about the Small Sponsor Community of Practice Group by logging into the member portal and visiting the Community of Practice webpage and knowledge portal.


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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 Metrics
3rd Thursday of the Month 10AM EST
Jan 16, 2020
Feb 27, 2020*
Mar 19, 2020
Imaging Performance
3rd Tuesday of the Month 10AM EST
Jan 21, 2020
Feb 25. 2020*
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EST
Jan 9, 2020*
Feb 4, 2020
Mar 3, 2020
Vendor Oversight
1st Wednesday of the Month 10AM EST 
Jan 8, 2020
Feb 5, 2020
*Meeting date deviates from regularly scheduled frequency.
 

MCC Best Practices Communities
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!

Best Practice Community
Meeting Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month 10AM EST
Jan 22, 2020*
Feb 12, 2020*
Mar 18, 2020
Small Sponsor Community
of Practice
Every Other Month 11AM EST
Feb 11, 2020
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EST
Jan 23, 2020*
Feb 12, 2019 at 11AM EST**
*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.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Cardiopulmonary Metric Toolkit v2.1 (ABPM, ECG, Spirometry)
Mar 4, 2020 11 AM EST
Central Lab Metrics v3.0
Mar 11, 2020 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Mar 10, 2020 10 AM EDT
eCOA Metric Toolkit v2.0
Mar 4, 2020 10 AM EST
Risk Assessment & Mitigation Management Tool v2.0
Mar 12, 2020 10 AM EDT
Site Contracting Metrics Toolkit v1.0
Mar 11, 2020 10 AM EDT
TMF Metrics Toolkit v2.0
Mar 10, 2020 11 AM EDT

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

Connect with MCC at Industry Events 
MCC staff looks forward to having good conversations with you in 2020. Please let us know if you are interested in scheduling a one-on-one meeting at any of the following events.

SCOPE
February 18-21, 2020
Orlando FL

Track: Implementing Risk-Based Monitoring – Part 1
Date: February 19, 2020
Session Title: “Risk-based Quality Management Strategy”
Session Participants: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium and Ann McCabe, Director, Process Excellence & Risk Management, Daiichi Sankyo, Inc.

Track: Managing Outsourced Clinical Trials
Date: February 21, 2020
Session Title: Vendor Oversight: Metrics, KPIs and ICH E6(R2)
Session Participant: Keith Dorricott, Ambassador, WCG-Metrics Champion Consortium

Learn More

Clinical Trial Innovation Summit
April 6-8, 2020
Cambridge, MA

Track: Risk-based Monitoring
Presentation: “Is Your Centralized/Onsite Site Monitoring Program Being Implemented per ICH E6(R2)? How Do You Know?”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Roundtable Discussion: “Implementation of Clinical Development Risk Management”
Session Participants: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium and Jonathan Rowe, Pfizer

Learn More

DIA 202 Global Annual Meeting
June 14-18, 2020
Washington D.C.

Track: 02 Clinical Trials and Clinical Operations
Presentation: “Management of Centralized, Remote, and Site Monitoring Models Using Metrics to Improve Process and Oversight”
Session Participant: Linda Sullivan, Co-Founder & Executive Director, WCG-Metrics Champion Consortium

Learn More

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

Please contact MCC Co-Founder and 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


Ask icon

  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 last month’s Ask The Expert and I wanted to ask advice on something I’ve often seen with risk assessment. As we go through the exercise of risk assessment, the study team comes up with lots of ideas on how to reduce risks. But during the study, those risks often still seem to materialize. Where might we be going wrong?

A: The exercise of managing risks is just that – most risks are managed rather than eliminated and so there is always a possibility for them to materialize as issues. It seems unlikely we will be able to eliminate all issues in clinical trials but good risk management should help reduce them (and their impact). Teams are typically working with imperfect information when they carry out risk assessments – clinical trials have many moving parts after all. Hopefully, many of the important risks have been identified through the risk assessment itself. The prioritization of those risks can be challenging with limited information though. If there is little past experience for a particular risk, then how do you score the likelihood of occurrence, for example? This really does emphasize the importance of an iterative and learning approach. Reviewing the risk assessment at points during the study will allow the team to remove risks that are no longer relevant, identify new risks, and reprioritize based on updated information.

There is another process error that you should watch out for when scoring risks. The MCC Risk Assessment Mitigation Management Tool allows you to score the Likelihood (L), Impact (I) and Detectability (D) of each risk. Sometimes, when scoring risks initially, teams will factor in risk controls they plan to put in place. So, for example, due to concern about the reproducibility of a particular lab measurement, the study team determines they will implement additional cross-checks and comparisons. Implementing these cross-checks and comparisons will mean they can detect an issue sooner (i.e. they will have an improved detectability score and a lower risk score). This may mean the risk score is low enough that that risk is not prioritized for risk reduction actions. However, if the study team fails to implement the cross-checks and comparisons, the true risk will be higher than the score assigned to the risk during evaluation. Thus, the scores for the risk assessment should be based on the existing processes otherwise you may end up with risks that are higher than you realized. Implementing the previously mentioned cross-checks could be implemented as a risk reduction step and the risk could be reassessed once the process is in place.

When issues occur, after the initial actions to contain and address the issue, you should take time to reflect. Was the issue recognized as a risk in the risk assessment? If not, should it have been? If it was, was it correctly scored and actioned? How should the risk assessment be updated given that the issue has occurred? What can you learn to help reduce the risk of recurrence?

MCC has resources that can help you:

  • The Risk Assessment and Mitigation Management Tool v2.0 (RAMMT 2.0) is available to those in member organizations. In 2020, we will be carrying out a further review and update of this tool
  • A new web-based course launched this year which is available at a discount to those in MCC member organizations – “MCCe301 Retooling Risk-Based Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management”
  • Study Quality Trailblazer LinkedIn Community where you can raise questions and debates on risk-based quality management with our user community

Education icon

  Education

Give the Gift of Metrics Knowledge with the MCC eLearning Institute
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

Learn more about the entire MCC Education Program on the following eLearning courses:

MCC e201: The Elements that Make Metrics Effective

MCC e202: Developing Effective Metrics Using a Structured Process

MCC e203: Effective Metric Visualizations to Gain Valuable Performance Insights 

MCC e204: MCC Metric Master Certification Independent Project

MCC e301: Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management


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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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