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June 2020

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  Important News

 

STAY TUNED … MCC’s Clinical Trial Optimization Podcast Channel is Launching in July 2020!
MicImagesMCC is pleased to announce the launch of 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. 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.

Sign-up to be notified when the first podcast is released.

MCC Relaunching eCOA Process Metric Work Group to Review eCOA Set-Up and Oversight – Initial Meeting on 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, after the initial meeting in July. The first meeting is open to the public.

Wednesday, 15-July-2020 11am 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’s Executive Director to Present Connecting Issue and Risk Management at MCC Compliance & CAPA Community of Practice Meeting on 14 July
QualityStampImageHave you ever wondered why the language of issues (CAPA, root cause, preventive actions) is so different to that in RBQM (risk identification, risk control, mitigation)?  Linda Sullivan will show how these two worlds are closely connected and discuss the implications for managing both issues and risks in clinical trials. Linda’s presentation will be based on an article published in the May Issue of Applied Clinical Trials.

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.
 

MCC Adds Metric Selection and Implementation Support Tools to Data Management/Biostatistics & Medical Writing Metric Toolkit v2.0
MetricImageMCC Data Management, Biostatistics & Medical Writing Metric Toolkit v2.0 -  released in 2018 – has the full complement of metric selection and implementation support tools.

Additional information about the MCC Data Management and Biostatistics Work Group can be found on the MCC website  MCC Members can log onto the MCC member portal to download the updated toolkit.

New - Metric Selection & Implementation Support Tools
Tool A: Key Performance Questions to Metrics
Allows you to select metrics based on the key performance questions you seek to answer
Tool B: Issues to Metrics
Allows you to select metrics based on the issues you seek to manage
Tool C: Basic/Advanced Metrics to Data Elements
Allows you to select metrics based on whether they are the basic ones recommended by the work group or are advanced ones for a deeper dive
Tool D: Data Elements to Metrics
Allows you to determine which metrics you could report when you select the data elements you have available
Tool E: Metrics Reporting Planning Worksheet
For use between sponsor and CRO. Specifies metrics to be used along with reporting frequency and responsibilities

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  Member News

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

MCC’s newest members are:

  • CrossPhase Consulting LLC

MCC thanks the following members for their renewal:

  • Daiichi Sankyo
  • Takeda
  • Technical Resources International

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  Work Group

Centralized Monitoring Community of Practice
Has COVID-19 Led to New KRIs? Find out what others are doing at next meeting!
The MCC Centralized Monitoring Community of Practice group will meet on Wednesday, 24-Jun-2020 at 10AM EDT to discuss the topic, Has COVID-19 Led to New KRIs? The discussion will be led by Nechama Katan, Director Data Science Lead at Pfizer. We anticipate this will be a lively session based on discussions in the COVID-19 work group where organizations have noted an increase in the use of Centralized Monitoring during the pandemic and the utilization of new KRIs to monitor the emerging risks.

Last month, the Centralized Monitoring Community of Practice explored the topic, Help, we can’t do SDV due to the pandemic – why Centralized Monitoring is the answer! MCC members can log into the member portal to watch a summary recording (8 minutes) and download the meeting slides.


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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
Jun 25, 2020*
Jul 16, 2020
Sep 17, 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
Jul 7, 2020
Aug 4, 2020
Oct 6, 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
Sep 24, 2020
Oct 13, 2020
Centralized Monitoring
3rd Wednesday of the Month at 10AM ET
Jun 24, 2020
Jul 15, 2020
Aug 19, 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
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
Sep 29, 2020 10AM EDT
Central Lab Metrics
Jun 24, 2020 11AM EDT
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: I work for a MCC member company and we are ramping up our Risk Based Quality Management processes and have found the MCC RAMMT v2.0 as an extremely helpful tool. In review of the tool, I was hoping to receive clarification on how KRIs play into #2 [Critical Data and Risks] and #3 [Risk ID Eval & Control]. After reading the instructions, I understand you utilize #2 to define critical data and processes, creating your if/then statement. These are not always detectable/controllable and may not always lead to a KRI. If the risk is something that is detectable/controllable, it’s my understanding KRI(s) would then be developed setting thresholds and/or QTLs.  Can you clarify where the KRIs are initially developed and thresholds are set?

A: Great to hear that you are finding the MCC Risk Assessment & Mitigation Management Tool (RAMMT) 2.0 useful. You are right that tab 3 “Critical Data & Risks” is designed to help develop your risks. You should consider the critical data, the associated processes to capture that critical data, and any other critical processes. The risks should be transferred onto tab 2 “Risk ID Eval & Control” where they can be evaluated. We also recommend you review reference tab A “Risk and Control Library” in case there are additional significant risks that should be added to your list of risks on
tab 3.

Once the risks have been scored for (L)ikelihood, (I)mpact and (D)etectability, you can order the risks by their risk scores and review the risks with high scores. With these risks, you will want to try to reduce them or eliminate them if at all possible – and this will involve taking actions to reduce one or more of the L, I or D scores. Example ways to reduce the likelihood score are improved instructions, training, checklists etc. It may be possible to reduce the impact score by developing a contingency plan that is ready to implement. And the detectability score can be reduced by improving or implementing a detection measure such as a Key Risk Indicator (KRI). The detection method should be one that provides a signal in plenty of time to act – see the MCC paper referenced below for more advice on developing leading metrics. Note that it is not necessary for all risks to be reduced – focus on the risks that matter, those with high risk scores. And not all risks need a detection method. In terms of Quality Tolerance Limit (QTL) parameters, these are really study level KRIs that are focused on key risks. They are focused on risks that if they are realized will lead to study failure e.g. patient dropout too high. The QTLs are the thresholds for those parameters.

Further MCC resources available:

  1. Paper: “Measure the Right Things at the Right Time: Design KRIs and KPIs that provide timely insights during study conduct” – available here.
  2. RAMMT Implementation Q&A meeting on 17-Jun-2020 at 10am EDT – Log into the Member portal to register for the meeting
  3. MCC eLearning Course 301: “Retooling Risk-Based Quality Management Approaches in the Era of ICH E6 (R2): Fundamentals of Clinical Trial Risk Management” – available at a discount to MCC member organizations. Details here.

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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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