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July 2019

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  Important News

MCC’s Clinical Trial Risk and Performance Management Summit is September 4–5, 2019 in Philadelphia
Reserve your seat at the Clinical Trial Risk and Performance Management Summit to explore opportunities and address challenges related to vendor management, metrics, risk-based quality management, recent regulations and team building skills. Early bird discount ends on July 25. Register today! Register today!
 

MCC’s Executive Director Participates in Public Workshop — Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations
The FDA is seeking feedback from stakeholders on the challenges, barriers and enablers that might be impacting the adoption of Risk-Based Monitoring (RBM) and related opportunities to improve RBM implementation.

This public workshop, held under a cooperative agreement with the U.S. Food and Drug Administration, was an opportunity to capture stakeholder input on:

  • The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction with central monitoring approaches
  • Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
  • Enablers that support implementation and execution of risk-based monitoring
  • How stakeholders assess impact of their RBM program
  • Remaining challenges to implementation or execution that need to be addressed

The workshop was in Washington DC on July 17. Linda Sullivan participated in two sessions:

  • Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
  • Session 6: Synthesis and Next Steps

Additional information is available at: https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-investigations
 

NEW! Vendor Oversight Quality Metric Toolkit Available to Members
The MCC Vendor Oversight Work Group – comprised of 75 individuals representing 33 organizations – worked collaboratively from June 2018 to March 2019 to develop 19 quality oversight metrics.

The work group used the MCC Metric Development Framework to explore:

  • Potential impact of ICH E6(R2) and how success is defined and the most important performance questions that can be answered with metrics
  • The most critical questions for the quality aspect of vendor oversight that we want metrics to help answer
  • Tools that can be used to help select the right metrics and to calculate them

The metrics are grouped into three categories: CRO oversight, CRO sub-contracted vendor oversight and functional oversight. A series of Key Performance Questions (KPQs) were developed to guide the metric development process. Detailed metric definitions that align with each of the KPQs are posted in the MCC Member Portal – Existing Metric Sets area, along with tools to aid selection, implementation and use of the metrics. A bonus feature is included in this toolkit – a spreadsheet that can be used to track the staff-related information and automatically calculate the MCC metrics.

A nine-minute video with confidential sections redacted is available on the Vendor Oversight public page on the MCC website. MCC members can access the un-redacted video by logging into the member portal.
 

Centralized & Site Monitoring Process Metric Work Group Needs Your Input
MCC is launching a Work Group to develop metrics that assess centralized monitoring and site monitoring processes. In preparation for that launch, we are seeking input on high level processes, current process issues and current metrics utilized to oversee and manage the processes.

This information will be used to help ensure the metrics we develop are in line with industry needs in this important area. Those in MCC member organizations can register for the first meeting on October 17, 2019 at 10 AM EDT by logging on to the MCC site.

Survey respondents will receive a summary recap of results. Your survey responses will be kept confidential.

Take Survey
 

Site Selection & Study Start-Up Metric Work Group Needs Your Input
MCC’s Site Selection & Start-Up Metrics Work Group will convene on October 1, 2019 to develop metrics that assess site selection and site start-up processes. In preparations for that meeting, we are seeking input on high level processes, current process challenges and issues, and current metrics utilized to oversee and manage these processes.

This information will be used to help ensure the metrics we develop are in line with industry needs in this important area. Those in member organizations can register for the first meeting on October 1, 2019 at 10 AM EDT by logging into the MCC member portal.

Survey respondents will receive a summary recap of results. Your survey responses will be kept confidential.

Take Survey
 

Help MCC Prioritize Topics to be Discussed in the Small Sponsor Community of Practice Group
The MCC Small Sponsor Community of Practice Group (CoP) has been established in response to feedback about the unique needs of smaller-sponsor members. This survey is designed to gather input from small sponsors about how they would like to use the CoP and the topics they would like to explore.

Survey respondents will receive a summary recap of results. Your survey responses will be kept confidential.

Take Survey
 

Member news icon

  Member News

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

MCC’s newest members are:

  • BAFallen Consulting - Betsy Fallen (MCC Ambassador)
  • Just In Time GCP
  • Rho, Inc.
  • St. Jude Children's Research Hospital

MCC thanks the following members for their renewal:

  • Baxter Healthcare
  • Cripps Clinical Consulting – Martin Cripps (MCC Ambassador)
  • Cyntegrity Germany GmbH
  • Kyowa Kirin Pharmaceutical Development, Inc. (US & UK only)
  • Merck Sharp & Dohme

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  Work Group

MCC Expands Opportunities for Members to Participate in Virtual Work Groups
Opportunities for members to participate in online virtual meetings and LinkedIn Communities have grown since its inception in 2006. Today, MCC members have the opportunity to participate in three types of online groups.

These groups are:

  1. Metric Development Work Groups: Members work collaboratively, through structured discussions, to develop and refine metric sets and tools
  2. Best Practice Communities: Members share ideas and practical approaches to address challenges unique to these communities
  3. Implementation Q&A Support Groups: Members are provided the opportunity to ask questions and share experiences related to implementing specific metric sets or tools at quarterly web-based meetings

Visit the upcoming meetings newsletter section for details about upcoming meetings.


Calendar icon

  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 at 10AM EDT
Oct 17, 2019
Dec 5, 2019
Imaging Performance
3rd Tuesday of the Month
at 10AM EDT
Sep 19, 2019
Oct 15, 2019
Site Selection and Start-Up Metrics
1st Tuesday of the Month 10AM EDT
Oct 1, 2019

Vendor Oversight
1st Wednesday of the Month 
at 10AM EDT 
Sep 11, 2019*
Oct 2, 2019
*Meeting 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!

 Work Group
Meeting Frequency
Date
Centralized Monitoring
3rd Wednesday of the Month 10AM EDT
Sep 12, 2019*
Oct 9, 2019
Small Sponsor Community
of Practice
Every Other Month 11AM EDT
TBD
Study Quality Trailblazer
2nd Wednesday of the Month 10AM EDT
Sep 12, 2019* **
*Meeting deviates from regularly scheduled frequency.
**Combined Meeting with Centralized Monitoring Work Group.
 

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)
Oct 3, 2019 11 AM EDT
Central Lab Metrics v3.0
Oct 9, 2019 11 AM EDT
Data Management, Biostatistics & Medical Writing Toolkit v2.0
Oct 8, 2019 10 AM EDT
eCOA Metric Toolkit v2.0
Oct 3, 2019 10 AM EDT
Risk Assessment & Mitigation Management Tool v2.0
Oct 10, 2019 10 AM EDT
Site Contracting Metrics Toolkit v1.0
Oct 9, 2019 10 AM EDT
TMF Metrics Toolkit v2.0
Oct 8, 2019 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.

MCC Staff Invite You to Attend the 2019 Clinical Trial Risk and Performance Management Summit
MCC 2019 Summit
September 4-5, 2019
Philadelphia, PA

Discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure, establishing your data requirements, aggregating reliable data, designing easy to understand metric report, and using metrics to identify areas of concern and conduct root cause analysis.

A sampling of what you’ll explore during the information-packed day-and-a-half summit include:

  • ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and other. How do regulators use data to determine where to conduct inspections? What challenges has risk-based quality management presented to others? How should you address such challenges? Get ready for answers from FDA, NHRA and EMA officials as well as industry top thinkers.
  • Squeezing Max Value Out of Data: Do your metrics answer the high-priority questions, reward the right behaviors, give you reliable time/quality readings? Speakers and panelist are ready with answers.
  • Data Quality: Designing data reports end-users can read and understand; aggregating in-house and CRO/vendor data; data governance and stewardship; and much more.
  • Predictive Analytics: Predictive analytics can help you with site selection, quality indicators and more. Discover savvy new ways to apply and test findings.
  • Critical Thinking Skills: Staff can be the weakest link. Discover creative new ways to move away from a “check the box” mentality.

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


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: We are a CRO and one of our customers has asked us to report staff turnover metrics on their studies. Staff might be moved due to promotion etc., but the client wants us to keep those in the metric. Does the MCC define a staff turnover measure and if so, what is included?

A: MCC’s Vendor Oversight Work Group discussed this topic at a meeting earlier this year. When staff work on a study, they gain knowledge about that study. Some is easily handed on to others but some is not – it is knowledge they don't even realize they have and is sometimes termed tacit knowledge. It is likely that more senior members of the team have more tacit knowledge and are going to be a higher risk in turnover. Here are some of the concerns associated with staff turnover:

  1. Has a handover of information been carried out appropriately?
  2. How long will it take for the new person to get up to speed?
  3. Is there a loss of tacit knowledge that might impact the quality and delivery of the study?
  4. Will there be a good working relationship with the new member of the team?

MCC work group participants decided to focus on turnover of key roles only as this is where most concerns arise. Additionally, the metric includes turnover only for those staff who have been replaced – so if a start-up specialist, for example, leaves the CRO after start-up has been completed, that person is not included in the metric. Departure of key staff who are replaced for any reason, including promotion or request from sponsor, are included in the metric calculation because even in these cases, the concerns A to D above remain. The metric definition includes a section Additional Analysis for Missed Target that describes how the data can be analyzed further. This is where we mention reviewing the reasons for turnover and give examples.

As you can see, there is a lot of thought, discussion and review in developing an MCC metric such as this. It is a collaborative effort. The MCC Vendor Oversight Quality Metric Toolkit is now available, including a staff turnover metric. The toolkit includes a tool to help with tracking the data and reporting on the staff turnover metric for those organizations that don't currently have the reporting mechanisms needed.


Education icon

  Education

MCC’s Learning Institute Helps Improve Clinical Trial Processes and Save Money
Clinical trial performance data can help save millions of dollars in improved processes but only if your people understand how to harness them. MCC’s “Mastering Performance Metrics” eLearning Program helps your key people master performance metrics and eliminate inefficiencies.

Metrics are the key to improving clinical research processes. But without an ability to translate the often overwhelming performance data stream, metrics are useless. Only people can link the numbers to improved processes and “Mastering Performance Metrics” eLearning courses make that link possible.

These courses use fast-paced audio, video and text to accommodate different learning styles — all on your own schedule. Your team members can choose to take one, two or all three courses as appropriate. All three courses allow you to earn ACRP and SOCRA CE credits and prepare you for Metrics Master Certification.

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

© Copyright 2019 by Metrics Champion Consortium

 
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