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November 2018

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  Important News

Successful MCC Webinar on Risk-Based Quality Management Leads to New Education Course
More than 200 participants joined Linda Sullivan, MCC Executive Director, and Keith Dorricott, MCC Ambassador, who facilitated the webinar, Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2) on October 18. The webinar was so successful that a new MCC eLearning course is now in development.

“The feedback we received was so positive that we are going to add some additional content to create a risk management course that will be available through the MCC eLearning education courses,” said Linda Sullivan. “The demand for such a course is so great that we plan to have the new course available by the end of 2018.”

During the fast-paced hour, Linda and Keith led discussions over:

  • Exploring new risk-based quality management requirements described in ICH E6(R2) section 5.0
  • The importance of critical thinking in risk assessment and risk control
  • Explaining the meaning of high and low detectability and the relevance to risk prioritization
  • Describing leading practices to improve risk assessment and quality oversight
  • Discovering how to develop and implement risk-based quality management programs to comply with ICH E6(R2)

MCC Releases Centralized Monitoring Guidance Document
Developed for MCC member organizations by a subgroup of the Centralized Monitoring WG, the guidance document, Considerations for Developing and Implementing Centralized Monitoring in Clinical Trials, discusses some of the key challenges, best practices and other factors that may influence the approach used by different organizations and study teams.

Centralized monitoring uses review methods that assess data and risks in a more comprehensive way across all sites in a study. Risk assessment methods may result in the identification of risk at various levels, including patient, site, country, region or study.

The guidance document covers:

  • The scope of centralized monitoring
  • How centralized monitoring impacts organizations
  • How centralized monitoring should be managed under an outsourcing model
  • Pre-study risk planning
  • The relationship between pre-study risk planning and centralized monitoring
  • If study-specific centralized monitoring plans are needed
  • Centralized Monitoring During Study Conduct
  • Study Closeout

MCC members can download the guidance document by visiting the Tools or Centralized Monitoring Work Group pages.

Keith Dorricott, Work Group Members Discuss Risk-Based Monitoring at SCOPE Europe
MCC Ambassador Keith Dorricott and members of the MCC Centralized Monitoring and Study Quality Trailblazer Work Groups had the chance to connect and discuss risk-based monitoring during the SCOPE Europe Summit for Clinical Ops Executives in Barcelona, Spain October 16-17.

Keith’s session, The Risk Assessment Is Done – Now What? Setting up Centralized Monitoring and Addressing the Gap in Critical Thinking, presented a case study on assessing risk, implementing a Key Risk Indicator and reviewing the risk after an unexpected issue occurred in a trial. Keith’s session generated much discussion and was well received. In addition to Keith’s presentation, four Centralized Monitoring Work Group members presented sessions on risk-based monitoring.

“The Risk-Based Monitoring track was a great opportunity to connect with not only the four work group members presenting at the summit, but also the other work group members who were in attendance,” said Keith. "There was a great atmosphere of sharing, questioning and learning at the conference with the challenges of critical thinking skills and Quality Tolerance Limits coming up many times. We're going to take this thinking back into our MCC work groups and explore some of the themes further at future meetings.”

MCC Congratulates the 2018 Class of MCC Champions
MCC bestows this special honor to those individuals who made significant contributions in 2018 in advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials.

The 2018 MCC Champions are:

Ciaran Cooper, USA
Nurcan Coskun, Switzerland
Kevin Douglass, USA
Amy Furlong, USA
Sindee Grossman, USA
Catherine Hall, USA
Alice Houzer, Netherlands
Bartek Jarosz, Poland
Linda King, USA
Olgica Klindworth, USA
Tracey Lavery, United Kingdom
Keith Morgenstern, USA
Rachel Oakley, United Kingdom
Armelde Pitre, USA
Johann Proeve, Germany
Sandra SAM Sather, USA
Diane Thornton-Chandler, USA
Steve Young, USA

Please join us in congratulating the 2018 MCC Champion award recipients!

A New Breakthrough MCC Report Takes a Hard Look at Site Payment Practices
One of the most surprising facts to emerge from MCC’s Industry Report Improving Clinical Site Payment Practices is the disconnect between clinical sites and sponsors/CROs.

Delayed payments from sponsors and CROs are putting their study sites in financial difficulty, leading many to turn away from clinical research altogether. Eighty-seven percent of sponsors/CROs believe clinical site payment is a critical process, but study findings show they don’t give it the attention it requires. In fact, the study finds most of them don’t even see the problem.

This research also gives you benchmarking data that can help you target specific payment practices for improvement. It covers the following payment issues:

  • Triggers sponsors and CROs use to initiate the payment process
  • Cycle time metrics used
  • Cycle time performance targets
  • How well “the payer” is performing against established performance targets
  • Frequency of occurrence of various payment problems
  • Strategies that have proven to speed the payment process

This report offers sponsors and CROs a detailed roadmap to the source of the most troublesome payment issues.

To purchase “Improving Clinical Site Payment Practices,” CLICK HERE now.

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  Member News

MCC Membership Increasing as Consortium Welcomes New Members
MCC welcomes 10 new organizations to the consortium and welcomes back returning members.

MCC’s newest member organizations are:

  • Analgesic Solutions
  • City of Hope
  • Gianni Benzi Pharmacological Research Foundation
  • Global Blood Therapeutics
  • Harper CRC
  • Innovaderm Research
  • Kaiser Foundation Research Institute
  • Saama Technologies
  • The Clinical Trial Company Ltd. (United Kingdom)
  • Yprime

MCC welcomes back the following member organizations:

  • CGI
  • CluePoints
  • Eli Lilly & Company
  • GSK (GlaxoSmithKline)
  • Inovio Pharmaceutical

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  Featured Work Group

MCC Metric Implementation Q&A Sessions Well Received
With the release of several new or revised metric sets, the MCC has started facilitating sessions for member organizations to ask questions and discuss implementation challenges.

The meetings have covered Data Management, Biostatistics & Medical Writing 2.0, Trial Master File 2.0 and RAMMT 2.0. The well-attended sessions have provided the opportunity for discussion and suggestions as well as demonstrations of metrics, tools and implementation support materials. The meetings have proven popular and the MCC will be running a further set in the New Year.

Go to the Upcoming Meetings section for the dates of the next session.

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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
Central Lab
1st Tuesday of the Month 10AM EDT
Dec 4, 2018
Jan 8, 2019
Feb 5, 2019
Mar 5, 2019
Central Monitoring
3rd Wednesday of the Month 10AM EDT
Jan 16, 2019
Feb 20, 2019
Imaging Performance
3rd Thursday of the Month 10AM EDT
Site Selection & Start-Up
2nd Thursday of the Month 10AM EDT
Study Quality Trailblazer 
2nd Wednesday of the Month 10AM EDT
Vendor Oversight
1st Wednesday of the Month 10AM EDT 
Dec 5, 2018
Jan 9, 2019
Feb 6, 2019
Mar 6, 2019

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
ECG Performance Metrics v2.1
Nov 27, 2018 11 AM EST
eCOA 2.0
Nov 27, 2018 10 AM EST


Take Advantage of an Opportunity to Connect with MCC in 2018
MCC staff looks forward to having good conversations with MCC Members at the following event.

December 11-12, 2018
ICH E6 Interactive Workshop: How to Build a Sponsor Risk Management Program
Raleigh, NC
Click here for more information and to register.

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  Ask the Experts

MCC Answers Your Metric Questions
Q: We've been looking at data on site contracting cycle time from draft contract sent to site to contract signed. We are struggling to know what to include in our comparisons and how to interpret the data. We saw the MCC had recently issued a set of site contracting metrics. Do you have any advice?

Meet The Experts

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

  Linda B. Sullivan
  Executive Director
  Metrics Champion Consortium

A: It's great to hear you're collecting data and then trying to interpret it. Understanding the underlying process behind the metrics is critical to being able to interpret the data correctly. The MCC Site Contracting Metrics 1.0 includes a process map and a glossary of terms to help ensure the metrics are used consistently. You might want to carefully consider the start and end point of your cycle time measurement. Processes prior to sending a draft contract to site can cause delays. And similarly, at the end of the process, if a signed contract is not actually available to be used, delays can be caused. The process map can also bring out other differences that might impact your comparisons. For example, if you include data from Phase IV studies, it may be that in those studies, the site contract is not negotiated but is rather a take-it-or-leave-it approach. In this case, the process is very different and including data from those studies will be likely to confuse and/or mislead.

The Site Contracting Metrics 1.0 introduced the MCC Global Start-Up Comparison Models. These show how ethics and regulatory submissions and approvals impact site contracting in different ways in different countries. In some countries, site contracting is completely independent of ethics and regulatory submission and approval, and is not on the critical path. For those countries, the cycle time may not be very important. However, for other countries, ethics and regulatory submissions can only take place once site contracting is complete. For these countries, the cycle time of site contracting is critical. There are five different models defined. Reviewing these as you compare cycle times would help you to make meaningful comparisons.

Validation of the underlying data is important, too. If dates of key timepoints are captured manually, there are likely to be errors (e.g. missing fields, wrong year entered). There will need to be a significant effort to clean the data prior to analysis so that the data does not mislead. Where dates are captured automatically in a system, there are likely to be fewer issues but you will need to understand what date is matched with what system activity and align it with the site contracting process.

Most importantly, when analyzing data such as this, be cautious before jumping to conclusions. Does what you are finding make sense? Can you trust the data? Would there be value in carrying out a statistical test to confirm significance? Analyzing the data can lead to great insights – based on fact rather than opinion. But make sure to always use your critical thinking skills so the data leads you in the right direction!

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MCC’s November Summit Included Metric Training Through Interactive Group Exercise
Critical thinking skills and how metrics influence behavior are just a few areas that were explored when participants took part in a case study group exercise during the MCC Clinical Trial Risk and Performance Management Summit November 14-15.

In this group exercise, participants separated into teams competing to uncover the root cause(s) of issues described in a case study. Each team was provided with a case study packet that included a description of the organization and outsourcing vendors, protocol synopsis, data reports, questions to explore and a worksheet to record the discussion. Teams compared results, discussed how they worked through the analysis and reflected on lessons learned.

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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.


Join the MCC LinkedIn Group to learn about industry performance metrics and stay informed of new developments.


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