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April 2019

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  Important News

MCC Metric Implementation Q&A Discussions Support Expansion of Metric Implementation Support Tools
Since the fall of 2018, the MCC has been running regular Implementation Q&A sessions on the metric toolkits and tools. In March, there were sessions for Data Management, ECG, eCOA, Site Contracting and TMF metrics as well as one session on the MCC Risk Assessment & Mitigation Management Tool v2.0. It was a chance for attendees to ask specific questions, see demos of the implementation tools and make suggestions for updates.

There was a lot of good discussion and topics covered including:

  • Issue-Driven Metric Selection Tools: Implementation sessions included demonstrations of a new implementation support tool designed to help organizations select metrics that relate to specific issues they might be having.
  • Metric Selection – Data Element Metric Selection Tools: The MCC has been introducing a tool into the metric sets that map metrics to required data elements and data elements to metrics. This is not in all toolkits yet, but will be over time. Each metric set includes a glossary of terms and wherever possible, we use industry definitions from ICH E6, CDISC, etc.
  • Comparison of ECG and eCOA Metrics: Why are the metric sets not similar? MCC metrics are developed by starting with developing the process map. While the process of eCOA and ECG are similar in some areas, there are significant differences. For example, eCOA include instrument validation and help desk services that are included in ECG. These differences are reflected in the metrics defined for each set.
  • Practicalities of Risk assessment: Members discussed the importance of leadership buy-in and why risk assessments should be carried out during the process of protocol amendment rather than after.
  • Timing of eTMF Set-Up: How early should an eTMF be set up? One of the MCC metrics specifically measures this and we discussed why it is defined the way it is, rather than on setup being by the time of first patient in.

We will continue with these Implementation Q&A sessions throughout the year. Those in MCC member organizations can secure their place by logging into the MCC member portal and using the available registration links next to the toolkit downloads and/or the work group meeting schedule.
 

Central Lab Metric Set Expanding to Include KRIs and Cover Portfolio, Study, and Site Level Performance
The Central Lab metrics have been undergoing review. The discussions with MCC member organizations have raised a number of interesting questions that we have been working through. They have implications for how we plan to develop metric sets in the future.

Different metrics users have different needs and we have expanded the metrics definitions to accommodate those needs. For example:

  • A small number of the metrics have been selected as potential Key Risk Indicators (KRIs) that could be used to monitor the risk to the study of the central lab process. Are there early indicators of staff turnover at site? Are there early indicators of missing critical data?
  • The metrics have been segmented into portfolio, study and site level metrics – each with their own formulas for calculating the metric, performance targets and metric reporting schedule. Portfolio level metrics can be used for vendor oversight across studies; study level metrics can be used for an individual study and if they are not to target, site level metrics will become useful.

We have also been developing tools to help with implementation:

  • Metrics Reporting Worksheet: This is for the vendor and sponsor/CRO to work through together and decide which metrics they are going to implement, whether the MCC definitions and targets will be used as-is, who will report and when. It helps to establish expectations from the start, at portfolio and/or study/site level.
  • Issues to Metrics Tool: This tool allows users to select common issues in the central lab process and see a list of recommended MCC metrics to consider that will help monitor the issues. It also lists the associated data elements and metadata that are needed to calculate the recommended metrics.

The developments in this metrics set will be adopted in other MCC metric sets over time. We are gathering feedback about top priority issues for Imaging, Cardiopulmonary, eCOA and Data Management. Survey results will be used as input to develop the Issues to Metrics Tools for each of those metrics sets. Click here to learn more information about the surveys.
 

MCC Work Group to Review Draft FDA RBM Q&A Guidance on April 17
The FDA issued expanded guidance (in draft) on A Risk-Based Approach to Monitoring of Clinical Investigations. The document consists of eight common questions and answers.

The MCC Centralized Monitoring Work Group will be reviewing the document at their meeting on April 17, 2019. They will be discussing whether the guidance affects any of the content in the comprehensive MCC Centralized Monitoring Guidance Document. We will consider whether we want to provide feedback within 60 days after publication. Those in MCC member organizations are encouraged to register for the meeting to join the discussion by logging into the MCC member portal and using registration links available on work group webpages and/or the work group meeting schedule.
 

Save the Date! MCC’s 2019 Summit will be held Sept 4-5, 2019 in Philadelphia
MCC’s 2019 Clinical Trial Risk and Performance Management Summit will take place at the Lowes Hotel in Philadelphia. More information will soon be released. The 2018 summit was a huge success! Don’t miss out on this year’s meeting. MCC members receive a registration discount. Learn more about the 2019 MCC Summit at visit www.mcc-summit.com.


Surveys icon

Surveys

New Tool to Link from Issues to Recommended Metrics: We Want Your Input
The Site Contracting and Trial Master File metrics toolkits include a novel tool to help organizations select the right MCC metrics. There has been great feedback on the tool and we are developing it for other metric sets.

With the tool, you can select the issue(s) that you have with the process (or those you want to guard against) and the tool provides recommended metrics for you to consider implementing. When the metrics were developed, the work group – experts in site contracting from across the industry – provided their input into the typical issues they come across. From this, MCC mapped the most relevant metrics and developed the “Issues to Metrics” tool. It helps organizations select the right metrics to help them improve. We are focused on developing a similar tool for Cardiopulmonary (ABPM, ECG, Spirometry), Data Management & Biostatistics and eCOA.

Are you interested in seeing the typical issues others have in these areas? We would like your input on what the common issues are that you face. We can map these to the existing metrics. Where this feedback highlights metric gaps, we will look at developing additional metrics. You can access the surveys below.

Cardiopulmonary
Data Management & Biostatistics
eCOA

The surveys close on April 30, 2019.
 

Risk Assessment – What Are Your Thoughts About Risk Scoring, Operational Complexity and KRIs?
MCC is soliciting feedback on:

  • How organizations are scoring risk (using a 1-3, 1-5 or a 1,4,7,10 scale)
  • Interest in developing a KRI selection tool
  • Updating the MCC Protocol Operational Complexity Scoring Tool

Let us know by taking this short survey and we’ll summarize the results at the Study Quality Trailblazer meeting on April 24, 2019.

Survey button

The survey closes on April 17, 2019.

Interested in working with others in the industry on these metrics? If your organization is not already a member, contact MCC Membership Director Terry Holland for more information.


Member news icon

  Member News

MCC Membership Increasing as Consortium Welcomes New Members
MCC welcomes the following new members and thanks those for their continued membership.

MCC’s newest members are:

  • Covance
  • CPC Clinical Research (Colorado Prevention Center)
  • GW Pharmaceuticals plc

MCC thanks the following members for their renewal:

  • AstraZeneca
  • Bluebird Bio
  • Clinical Pathways LLC
  • inSeption Group
  • Mitsubishi Tanabe Pharma Development America

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  Featured Work Group

Centralized Monitoring Work Group Agrees Approach to Quality Tolerance Limits
Quality Tolerance Limits (QTLs) is a regular topic area at industry conferences on Risk-Based Quality Management. Many organizations are finding implementation of QTLs challenging.

This month’s Ask The Expert features a question received by the MCC on QTL implementation. The Centralized Monitoring Work Group has dedicated two meetings to QTLs this year and these were two of the best-attended meetings to date. By considering the TransCelerate Biopharma approach, real life examples from member organizations and some of the challenges of metrics definition, the work group has come to a consensus approach for implementing QTLs. Later in 2019, there will be an addendum to the MCC Centralized Monitoring Guidance Document focusing on QTLs to help organizations navigate the challenges of QTL selection, implementation and use.


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  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
Apr 17, 2019
May 15, 2019
Jun 19, 2019
Imaging Performance
3rd Tuesday of the Month
at 10AM EDT
Apr 16, 2019
May 21, 2019
Jun 18, 2019
Study Quality Trailblazer 
2nd Wednesday of the Month
at 10AM EDT
Apr 24, 2019*
May 23, 2019*
Jun 20, 2019*
Vendor Oversight
1st Wednesday of the Month 
at 10AM EDT 
May 2, 2019*
Jun 5, 2019
*Meeting deviates from regularly scheduled frequency.
 

MCC Metric Sets and Tools Implementation Support Group Meetings
These newly created type of online meetings are 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
TBD
Data Management, Biostatistics & Medical Writing Toolkit 2.0
Jun 11, 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
Site Contracting Metrics Toolkit 1.0
Jun 13, 2019 10 AM EDT
TMF Metrics Toolkit 2.0
Jun 11, 2019 11 AM EDT

 

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

Clinical Trial Innovation Summit
May 13-15, 2019
Boston, MA

Session Title: Connecting CAPA Preventative Actions to Quality Risk Management to Reduce Systemic-Level Risks on New and Ongoing Studies

Session Information:

  • Explore the link between sections 5.0 (Quality Management) and 5.20.1 (Noncompliances) in ICH (R2)
  • Discuss the importance of documentation of CAPA Action Plans and Quality Management decisions and actions
  • Describe resources developed by an industry consortium that support CAPA Management and Quality Risk Management

Session Participation: Linda B. Sullivan, MBA, Executive Director, Metrics Champion Consortium

Session Title: Using Site Contracting Performance Metrics in Site Selection – Do You Have Access to the Right Data to Understand How the Site Performed?

Session Information:

  • Explore why site contracting cycle times vary by country
  • Discuss approaches organizations are using to reduce cycle time results
  • Review the data your organization should be reviewing to gain insights about which sites perform well in the context of local regulatory and ethical review requirements  

Session Participation: Linda B. Sullivan, MBA, Executive Director, Metrics Champion Consortium
 

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

Session Participation: Keith Dorricott, Ambassador, Metrics Champion Consortium
 

DIA Annual Meeting
Tuesday, June 25, 2019 10:30 am - 11:30 am
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

Ask icon

  Ask the Experts

MCC Answers Your Metric Questions
Q: ICH E6(R2) specifies that “predefined quality tolerance limits should be established.” Is such a quality tolerance limit a metric? And does the MCC have any recommendations on approach to implementing these?

Meet The Experts

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




  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium
 
 
 

A: The MCC Centralized Monitoring Work Group discussed quality tolerance limits at the February and March meetings. Those in MCC member organizations can access webinar summaries of those meetings on the MCC website. The work group plans to develop an addendum to the Centralized Monitoring Guidance Document that was published in November to cover the practicalities of quality tolerance limits.

The graphic below summarizes the basic approach and aligns with the approach described by TransCelerate Biopharma:

As shown, the quality tolerance limit is at a defined level of specific parameter (or metric) – the quality tolerance limit is not itself a metric. The parameter (in this example, percent of subjects not meeting the protocol inclusion/exclusion criteria) is what is tracked over time. When the parameter goes above the quality tolerance limit, action should be taken to try to bring the parameter back into an acceptable range.

A secondary limit can also be defined to specify when action should be considered prior to breaching the quality tolerance limit, with the aim of keeping the parameter inside the acceptable range at all times. There are a number of different approaches across MCC member organizations to the selection of the specific parameters. Some aim to use the same parameters across all studies whereas others vary between studies. In our discussions, all organizations agree the use of quality tolerance limits is still in its infancy and they are learning through the practice of implementation.


Education icon

  Education

Does Your Organization Understand Risk and How to Implement Risk Management in Your Clinical Research Program? MCC Risk Management Course is Available – Register Today
MCC is pleased to announce that MCC eLearning Course 301 – Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2): Fundamentals of Clinical Trial Risk Management is available for purchase in the MCC store (MCC members receive a 20% discount).

This course is an expanded, upgraded version of a complimentary live webinar presented by Linda Sullivan, MCC Co-Founder and Executive Director and Keith Dorricott, MCC Ambassador in October 2018. Due to the overwhelming response and positive feedback, the webinar content was expanded into a one-hour, hands-on, on-demand training course during which Linda and Keith walk 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.

At the conclusion of the course, learners are 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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Metrics Champion Consortium,  300 N. Washington St.,  Falls Church, VA 22046,  United States 
Phone (617) 948-5100 | Toll free (866) 219-3440

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