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May 2019

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  Important News

MCC’s 2019 Summit Agenda Now Available – Register Today!
MCC’s 2019 Clinical Trial Risk and Performance Management Summit will take place September 4-5 at the Loews Hotel in Philadelphia. Secure your spot by registering today! Early Bird pricing will be in effect through July 25. MCC members receive a registration discount. To learn more about the 2019 MCC Summit, view the agenda and register, please visit www.mcc-summit.com.
 

MCC Launches New Small Sponsor Community of Practice Group
In response to feedback about the unique needs of smaller sponsors, the MCC formed the Small Sponsor Community of Practice Group. The first meeting will take place on June 4, 2019 at 11 AM EDT. Meetings will take place every other month.

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 page on the MCC website where self-help resources such as short videos, implementation guides and links to relevant MCC resources are available.

MCC members interested in joining the Small Sponsor Community of Practice Group can log into the MCC member site and use the registration link found under the “Meetings & Work Groups” tab and then “Small Sponsor Community of Practice Group” to register for the June 4, 2019 meeting.

Not an MCC member? Contact MCC Membership Director Terry Holland for information on becoming an MCC member.
 

New MCC Central Lab “Next Generation Metric Toolkit” Includes Metric Selection and Implementation Tools
MCC is pleased to announce the introduction of “Next Generation Metric Toolkits” that include significant upgrades, metrics segmented by level (portfolio/study/site), metric selection tools and a metric reporting planning worksheet.

After undergoing an extensive review, the MCC Central Lab Metrics v3.0 toolkit is now available on the member portal. MCC plans to release additional enhanced metric toolkits over the next six months. Why are the updates important? These tools solve a major problem for organizations seeking to adopt MCC standardized metrics, namely how to select the right metrics for their program.

The new tools enable organizations to select metrics that:

  • Answer key performance questions (identified by consortium members)
  • Manage common issues (identified by consortium members)
  • Provide the basic measures all organization should adopt
  • Can be reported based on availability of data elements

In addition to the metrics selection tools, a metric reporting planning worksheet has been developed that sponsors/vendors teams or internal teams can use to record which metrics are going to be used, who will report the metrics and how often metric results will be reviewed.

MCC members can download the updated Central Lab Performance Metrics v3.0 by logging into the member website and clicking on the Existing Metrics Sets tab.
 

Site Contracting Metrics Toolkit v1.0 Updated to Include Full Compliment of “Next Generation Metric Toolkit” Components
The Site Contracting Metrics Toolkit v1.0 is being converted to a “Next Generation Toolkit” that will include updated and new components designed to help organizations seeking to adopt MCC standardized metrics to select the right metrics for their program.

“We are not changing any of the metrics but are putting together a more comprehensive set of tools to help with the selection and implementation,” said Keith Dorricott, MCC Ambassador.

Support tools include:

  • Metric Toolkit and Implementation Guide that provides an overview to the toolkit and a step-by-step guide to help with metric selection and implementation
  • Recorded webinar introducing the toolkit
  • Process Map showing the location of the MCC metrics in relation to the high-level process
  • Metrics workbook to define each metric

Support tools include five easy to use tools. Each has a short three-minute demo:

  • Key Performance Questions (KPQs) to metrics to determine recommended metrics to help answer KPQs 
  • Issues to Metrics to determine recommended metrics for particular issues
  • Basic/Advanced Metrics to Data Elements to determine the data elements needed to calculate selected metrics
  • Data Elements to Metrics to determine metrics available with a given set of data elements
  • Metric Reporting Planning Worksheet for use between sponsors, CROs and other vendors to define the responsibilities and frequency of reporting
     

MCC Ambassador Ranks are Growing! Searchable Data Base Connects You to Consultants
MCC has a membership designed especially for our consulting companies, both solo practitioners and consulting firms of two or more. We are building our Ambassador network of consultants, who have both functional area expertise and performance metric knowledge. Upon meeting program selection criteria, MCC Ambassadors are given MCC member privileges and invited to add their contact information to the MCC Industry Profile Database available to the public on the MCC’s public website.

To be eligible for the MCC Ambassador program, you need to:

  • Have 10-plus years of experience in the Clinical Research Industry
  • Provide consulting services to Sponsors, Service Providers or Investigator Sites
  • Successfully complete our MCC metric eLearning courses
    • MCC e201 – Elements That Make Metrics Effective
    • MCC e202 – Developing Effective Metrics Using a Structured Process

Membership Benefits at the MCC Ambassador Silver-level include:

  • Access to extensive library of proprietary MCC metric toolkits and metric implementation support tools (Metric toolkits include process maps, detailed metric definitions and performance targets, implementation guide and metric selection tools)
  • Access to MCC Risk Assessment & Mitigation Management Tool
  • Access to MCC Cost of Poor Quality Estimator Tool
  • Access to MCC Protocol Operational Complexity Scoring Tool
  • Access to MCC Site Key Risk Indicators library
  • Access to MCC Risk-based Monitoring Pilot Success Factor Metrics
  • Company name and logo displayed on MCC website
  • Firms with two or more consultants may have one consultant listed on our Searchable Database
  • Eligible to participate in MCC online work groups
  • Access to MCC Member-only LinkedIn Community groups
  • Access to MCC Resource Library - MCC Case Studies
  • Complimentary MCC Work Group News (monthly)
  • 20% off conference registration, management reports, eLearning courses
  • Complimentary pass – Member-only dinner event for MCC Risk and Performance Management Summit registered attendees

Our rates are based on your company size, including a Solo Practitioner rate. If you are interested in joining the MCC Ambassador Network, please contact our Membership Director, Terry Holland.


Member news icon

  Member News

MCC Membership Increasing as Consortium Welcomes New Members
MCC welcomes the following new members.

MCC’s newest members are:

  • Alcoam by Design
  • Astellas Pharma
  • Bill & Melinda Gates Medical Research Institute
  • Mallinckrodt Pharmaceuticals
  • Pharma Initiatives
  • Pure Health Consulting - Jacob Ehrlich

Working group icon

  Featured Work Group

Centralized Monitoring Work Group Discusses Draft FDA Risk-Based Monitoring Q&A
In March, the FDA issued the risk-based monitoring draft as further guidance to the FDA’s 2013 Guidance Document “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.” The Centralized Monitoring Work Group had record attendance at their April meeting with more than 35 attendees and 25 organizations represented.

The lively discussion included points such as:

  • Is there an opportunity to clarify some terms – such as “monitoring” and “monitoring plans”? Are these meant to be focused on site monitoring or more broadly on quality oversight?
  • Two of the questions could be clearer in the use of the term “corrective action” and also referencing root cause analysis per ICH E6(R2) 5.20.1.
  • The requirements for recording activities related to centralized monitoring could be clearer.

The feedback has been collated and is undergoing final review before providing feedback to the FDA.


Calendar icon

  Upcoming Meetings

MCC Monthly Work Group Meetings
Meetings are open to participants from MCC member organizations. To register for a work group meeting or for a detailed list of meeting dates and times, please log into the member portal or contact Customer Service for assistance. Not a member? Join today!

 Work Group Meeting
Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month at 10AM EDT
May 15, 2019
Jun 19, 2019
Jul 17, 2019
Sep 25, 2019*
Oct 16, 2019
Imaging Performance
3rd Tuesday of the Month
at 10AM EDT
May 21, 2019
Jun 18, 2019
Jul 16, 2019
Small Sponsor Comm of Practice
Every Other Month at 11AM EDT
Jun 4, 2019
Study Quality Trailblazer 
2nd Wednesday of the Month
at 10AM EDT
May 23, 2019*
Jun 20, 2019*
Vendor Oversight
1st Wednesday of the Month 
at 10AM EDT 
Jun 5, 2019
Jul 10, 2019*
Sep 11, 2019*
Oct 2, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Metric Sets and Tools Implementation Support Group Meetings
These newly created meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing specific metric sets or tools.

 Metric Set/Toolkit Implementation Q&A
Date & Time
Cardiopulmonary Metric Toolkit v2.1 (ABPM, ECG, Spirometry)
May 22, 2019 10 AM EDT
Central Lab Metrics v3.0
Oct 9, 2019 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Jun 11, 2019 10 AM EDT
Oct 8, 2019 10 AM EDT
eCOA Metric Toolkit v2.0
May 22, 2019 11 AM EDT
Risk Assessment & Mitigation Management Tool v2.0
Jun 13, 2019 11 AM EDT
Oct 10, 2019 10 AM EDT
Site Contracting Metrics Toolkit 1.0
Jun 13, 2019 10 AM EDT
Oct 9, 2019 10 AM EDT
TMF Metrics Toolkit 2.0
Jun 11, 2019 11 AM EDT
Oct 8, 2019 11 AM EDT

 

Connect with MCC
MCC staff looks forward to having good conversations with you in 2019.

Meet with MCC Ambassador Keith Dorricott at the European Inspection Summit
European Clinical Trials Inspection Readiness Summit
May 16–17, 2019
London, UK

Session Title: Bridging the Gap Between CAPA and Quality Risk Management to Prevent Systemic-Level Issues

Session Information:

  • Examine the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH E6(R2)
  • Explore toolkits developed by an industry consortium that support Quality Risk Management and align with inspector expectations
  • Discuss the importance of documentation of Quality Management decisions and actions for inspection readiness and approaches to achieve this

MCC’s Linda Sullivan Looks Forward to Connecting With You During DIA
DIA Annual Meeting
Tuesday, June 25, 2019 10:30am - 11:30am
San Diego, CA

Session Title: Retooling Risk Assessment to Align with ICH-E6(R2) and Connect to Centralized Monitoring and Risk-Based Monitoring

Session Information:

  • This session will explore new approaches to quality risk management implemented by stakeholders since the adoption of ICH E6(R2) and the vital role of critical thinking and metrics in bridging from risk assessment to centralized monitoring

Moderator

  • Linda B Sullivan, MBA Executive Director, Metrics Champion Consortium

Panelists:

  • Suzanne Lukac, Senior Account Director, CluePoints
  • Ann McCabe, Director, Process Excellence and Risk Management, Daiichi Sankyo Inc.
  • Sherry Merrifield, Senior Director, Global Operations Management, Syneos Health

MCC Staff Invite You to Attend the 2019 Summit
MCC 2019 Summit
September 4-5, 2019
Philadelphia, PA

Go to www.mcc-summit.com for more information.


Ask icon

  Ask the Experts

MCC Answers Your Metric Questions
Q: I've been reviewing the MCC corrective and preventive action (CAPA) metrics and similar to ICH E6(R2), corrective and preventive actions are referred to together. I have always thought the corrective actions are to contain the immediate issue and preventive actions are to try and stop it recurring. But that's not the definition in the glossary in the MCC metric workbook. Can you explain some more?

Meet The Experts

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




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: You're right – ICH E6(R2) 5.20.1 states "[for a significant noncompliance] the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions." This is an important addition to ICH E6(R2) but it doesn't help clarify the terms corrective action and preventive action. It is immediate actions (sometimes called containment actions or corrections) that are aimed at trying to contain an issue. These are the actions that you can implement without knowing the root cause(s). For example, in a car accident they are the actions such as getting passengers safe and turning off the engine.

Corrective actions, meanwhile are the ones where ideally, you have a good understanding of root cause(s). They are actions designed to act on those root causes or to stop the cause-and-effect chain of events so that a similar issue doesn't recur. In a car accident, you might discover it was caused by a tire failure and that an inferior re-tread brand was used. A corrective action would be to use better quality tires in future.

ICH E6(R2) does not link preventive actions and reducing risk by risk-based quality management (section 5.0) but the international quality standard ISO9001:2015 does make that important link between preventive actions and risk reduction. Preventive actions are really risk reductions or risk controls. They are aimed at reducing the risk of the issue from occurring in the first place. In the car accident example, a preventive action may involve a regulatory agency taking action to ensure only a certain quality of tire can be purchased and fitted.

MCC staff will be presenting on this topic at events in May and MCC will be issuing a white paper on this topic shortly.


Education icon

  Education

Learn How to Develop and Implement Risk-Based Quality Management Programs to Comply with Regulatory Updates – Register Today
Recent updates included in ICH E6(R2) section 5 (Quality Management) mean that the quality management methods used to assure and control the quality of the trial 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 you 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

You have to develop and implement risk-based quality management programs to comply with ICH E6(R2). You owe it to yourself to discover how.

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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Phone (617) 948-5100 | Toll free (866) 219-3440

© Copyright 2019 by Metrics Champion Consortium

 
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