Metrics Champion Consortium
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November 2019

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  Important News

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Save the Date! MCC's 2020 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. Please contact MCC Executive Director and Co-Founder 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 panellist. Click here to learn more.
 

MCC Small Sponsor Community of Practice Group Meeting on December 3 to Discuss Inspection Readiness and TMF Metrics
The MCC Small Sponsor Community of Practice Group will meet on December 3, 2019 to discuss how adoption of the MCC TMF metrics and associated tools can help organizations improve TMF quality.

The TMF Artifacts Mapping Tool helps organizations define when artifacts are needed in the TMF and the TMF Assessment Tool can be used to track and calculate the QC metrics defined in the MCC TMF metrics toolkit. There will be opportunities for questions and discussions on the practicalities of ensuring TMFs meet quality and timeliness requirements.

MCC is launching the Small Sponsor Community of Practice Group in response to feedback about the desire of smaller sponsors to have an opportunity to interact with their peers to discuss the unique needs of smaller sponsors.  The purpose of this new group is to provide members with the opportunity to:

  • Get up-to-date news on MCC Performance Metric Sets and Tools
  • Provide feedback to MCC about the metric selection and implementation support tools
  • Share ideas and practical approaches that work in small sponsor settings
  • Learn from their peers

The Small Sponsor Community of Practice Group has a dedicated area in the MCC member portal where self-help resources such as short videos, implementation guides and links to relevant MCC resources are available. Additionally, a special LinkedIn community has been established for MCC members to interact online outside of the meeting times.

Members can register for the December 3 meeting by visiting the Small Sponsor Community of Practice page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.
 

MCC Best Practices Group to Discuss Updates to the MCC Protocol Operational Complexity Scoring Tool to Support Use by Patient Engagement Programs 
MCC staff and a subset of members have been exploring how the MCC Protocol Operational Complexity Scoring Tool v1.0 could be modified and used to identify study team, site and patient burden prior to study conduct during the protocol development process.

For example, the tool could be used to identify draft protocols with high patient burden that could benefit from gathering input from patient advisory boards and track protocol modifications resulting from the input. A revised version of the tool will be shared at the Study Quality Trailblazer meeting on Wednesday, November 13, 2019. The draft version of the tool will serve as the foundation for the group to build version 2.0 to be released in Q1 2020.

 Members can register for the November 13 meeting by visiting the Study Quality Trailblazer page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.

Click here to learn more about the MCC Protocol Operational Complexity Scoring Tool.
 

MCC Membership Fees Increasing in 2020 – Act Now to Lock In 2019 Rates!
MCC thanks our members for their support to develop standardized process performance metrics and tools to improve clinical trials. Together, we are working to achieve our mission to bring clinical research stakeholders together, including sponsors, CROs, partners and investigational sites, to collaboratively develop standardized performance metrics and associated tools that help organizations oversee, manage and optimize clinical trial execution. Over the last 13 years, our focus has expanded beyond the original time, cost and quality metrics to include risk-based quality management and protocol operational quality tools. MCC has become the place to meet industry peers, exchange ideas, collaborate and think.

 Today, MCC programs support the mission through helping organizations:

  • Gain insights about what others are doing. Interactive communication among our members participating in surveys, best practice community discussions and metric development work group activities allows for multi-industry stakeholders, including sponsors, CRO’s, sites and vendors to share ideas in a pre-competitive environment to learn how to work together more effectively.
  • Define what to measure. MCC metric experts facilitate member-only work groups that develop/update performance metrics and risk/quality tools. Members report that participation in the virtual work groups is a high value activity. 
  • Determine which metrics are right for their program and how to communicate selection with other stakeholders. During the last 12 months, MCC has invested in developing implementation support resources to help small, medium and large organizations select the right MCC metrics for their programs. This significant breakthrough has been highly praised by members and will be rolled out across the metric sets in 2020. Specifically, four new metric selection tools allow users to select MCC metrics based on the following criteria:
      • Key performance questions they are trying to answer
      • Issues they are trying to manage
      • Basic-level vs. advanced-level metrics
      • Data they have readily available
  • Learn how to implement risk-based quality management and performance metric programs. Successful implementation of risk-based quality management and performance metric programs requires both selecting the right metrics and tools AND training staff to use metrics and tools to effectively manage your programs. The MCC Learning Institute eLearning program offers foundational training in two tracks: Mastering Risk Management and Mastering Performance Metrics, including a Metric Master Certificate program. MCC members receive a discount on single and group e-courses rates. Some members have licensed the e-courses for use on their internal learning management systems.

In order to continue to provide these benefits including the most current metrics and toolkits, detailed and user-friendly implementation tools, facilitated interactive work groups, access to industry subject matter experts, industry reports and white papers, and on-line education, we will be increasing our membership rates beginning January 1, 2020. 

In 2020, our fees will go to support the development of the following:

  • New metric toolkits (e.g. Vendor Oversight Financial Metrics, Site Selection and Study Start-Up Metrics, and Centralized and Site Monitoring Process Metrics)
  • Review and updates of existing metric toolkits including ECG, eCOA and Imaging metrics
  • Release of an expanded version of the Protocol Operational Complexity Scoring Tool that generates study management, site and patient burden scores
  • Release of version 3.0 of the Risk Assessment and Mitigation Management Tool
  • Development of metric selection tools for all our metric sets
  • Expansion of the MCC Knowledge Portal
  • Hosting of Subject Matter Expert Webinars

We will continue to offer our three tiers of membership – Silver, Gold and Platinum. If you would like information on the benefits and pricing for each level, please contact MCC Membership Director, Teresa (Terry) Holland at tholland@metricschampion.org. If you would like to join the MCC, lock in your 2019 rate for next year, or would like to learn more about multi-year agreements and discounts, Terry will be happy to help you. Thank you again for your support of the MCC!


Member news icon

  Member News

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

MCC’s newest members are:

  • Abbott

MCC thanks the following members for their renewal:

  • CluePoints SA
  • Kaiser Foundation Research Institute
  • Novo Nordisk US / Canada
  • Wool Consulting Group

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  Work Group

MCC Hosts Implementation Q&A WG Meeting to Discuss MCC CAPA Metrics on Dec 4
The MCC Clinical Corrective Actions, Preventive Actions (CAPA) Progress Metrics Toolkit v1.0 was released in May 2016 and a meeting on December 4, 2019 at 11 AM EST will assess the success of its implementation and if additional metrics are needed.

MCC members who are currently using or have used the MCC CAPA metrics are encouraged to join this meeting, led by Keith Dorricott, MCC Ambassador, to give their input. Members can register for the December 4 meeting by visiting the Meetings page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at lknitter@metricschampion.org for assistance.

The MCC offers quarterly Implementation Support meetings to provide members the opportunity to ask questions and share experiences related to implementing current MCC metric sets, as well as gather suggestions for additional metrics to be considered.


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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
Dec 5, 2019*
Jan 16, 2020
Feb 27, 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 14, 2020*
Feb 4, 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*
Small Sponsor Community
of Practice
Every Other Month 11AM EST
Dec 3, 2019
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EST
Nov 13, 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
Clinical Corrective Actions, Preventive Actions (CAPA) Toolkit v1.0
Dec 4, 2019 11 AM EST
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
MCC staff looks forward to having good conversations with you in 2019.

Clinical Trials Europe 

Date: November 21, 2019
Location: Barcelona, Spain

Session Title: “The Impact of Risk-based Quality Management on Vendor Oversight”

Session Participant: Keith Dorricott, Contractor for Metrics Champion Consortium (MCC)

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’ve taken over as Study Manager and we are reviewing the risk assessment that was carried out prior to study start. The risks have been scored for Likelihood, Impact and Detectability but it is difficult to understand what the actual risks are that each score represents. We have some examples where my team can think of several risks related to a single question in our risk tool. I know the MCC has a risk assessment tool and wondered if you had any advice on this?

A: The good news is that a risk assessment, prioritization and control exercise was carried out prior to study start. The bad news is you are encountering difficulties because the assessment team did not provide adequate documentation of their discussions and decisions. Your situation demonstrates how important it is to standardize your approach and document decisions clearly. Ideally, there should be a rubric defining what each Likelihood (L), Impact (I) and Detectability (D) score means so scoring is completed in a consistent manner across studies. Additionally, each high risk score should have information about what the risk is and what was considered when the score was generated. MCC’s risk tool, named Risk Assessment and Mitigation Management Tool (RAMMT) includes a standardized scoring rubric and field to add a risk statement which helps everyone understand the risk, the conditions that can lead to the risk becoming an issue and impact of the issue.

Unfortunately, if the documentation is as poor as you describe, you may need to repeat the exercise to ensure the right risks are prioritized and controlled. As you do that, make sure the approach is documented as well as the decisions you make. This exercise could be extremely valuable in the case of a regulatory inspection – as long as it is well documented.

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.” (See Education)
  • Study Quality Trailblazer LinkedIn Community where you can raise questions and debates on risk-based quality management with our user community

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  Education

Learn the Fundamentals of Risk-Based Quality Management through MCC’s eLearning Course 301
Quality management methods used to assure and control the quality of clinical trials should be proportionate to the risks inherent in the trial and the importance of the information collected. MCC’s eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management will help organizations understand risk-management concepts.

Presented by Linda Sullivan, MCC Co-Founder and Executive Director and Keith Dorricott, MCC Ambassador, this one-hour, hands-on, on-demand training course walks through risk management concepts, and learners apply the concepts by reviewing a case example and completing the risk assessment and control log included in the course material.  All MCC members receive a 20% discount!

At the conclusion of the course, learners are be able to:

  • Explain the concept of risk and its management
  • Describe risk management in clinical research and the relevance of ICH E6(R2)
  • Identify critical data and processes and use process maps to identify areas of risk
  • Develop risk statements and evaluate risk
  • Describe approaches to controlling risks in clinical research
  • Mitigate some common implementation challenges

To comply with ICH E6(R2), organizations have to develop and implement risk-based quality management programs. Discover how with MCC’s Risk-Based Quality Management eLearning course.

Learn more about the MCC e301 eLearning course.


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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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