When is Site Data Entry Complete? The Need for a Universal Definition

Monthly Archives: February 2018

When is Site Data Entry Complete? The Need for a Universal Definition

Wednesday, February 28, 2018

MCC’s Clinical Trial Site Date Entry Study finds there is a lack of agreement on how the industry defines the “data entry complete” time point.

The MCC Industry Practices Insight Report, “Clinical Trial Site Data Entry Study: An examination of how organizations measure site data entry cycle times, performance expectations compared to actual results and site management strategies,” reveals that the “Site Data Entry Cycle Times” metric is very important to organizations but there is no consistency on when data entry is considered complete.

Some organizations define data entry as “complete” when a single data point for the visit has been entered into the Electronic Data Capture (EDC) system, while others define data entry as “complete” when all data for a complete visit have been entered into EDC.

Timely data entry by sites following subject visits is becoming more important with the adoption of the ICH E6 (R2) Addendum and the increasing focus on risk management in clinical trials. Delayed data entry can lead to increased risk to both subjects and the trial.

This study reveals an industry gap could be a significant source of risk unless quickly addressed and a resolution of definition, use, expectation and continuous improvement of this important cycle time metric is needed. Additionally, the study looks at performance expectations compared to actual results and site management strategies.

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You’ve Run Your Partnership Survey and Have Your Data, Now What?

Tuesday, February 27, 2018

The MCC Vendor Oversight Work Group will address how to analyze partnership survey data when they examine a case study and look at the analysis and metrics used. All MCC member organizations are invited to attend the March 7, 2018 meeting and be a part of the discussion.

The Vendor Oversight Work Group has developed 10 metrics for use when analyzing data from a partnership survey. These metrics are aimed at assessing different aspects of a partnership such as:

  • Clarity of expectations
  • Issue resolution
  • Decision-making
  • Partnership value
  • Resources

An MCC member organization has tested the approach to a partnership survey and has analyzed the data. They conducted the survey twice with a baseline and follow-up to see if any changes occurred. At the meeting, a representative from the organization will share the summary data from the surveys and discuss some of the challenges when analyzing survey data. She will also be available for a Q&A session.

Meeting attendees will review the proposed metrics and decide if any modifications or additions need to be made based on the case study findings.

To register for the meeting, log into the MCC Member portal and click on the Vendor Oversight Work Group webpage.

For more information contact the Vendor Oversight facilitator Keith Dorricott, MCC Ambassador.

Imaging Performance Work Group Readies for First Meeting in March

Monday, February 26, 2018

The MCC Imaging Performance Work Group’s first meeting will take place on March 15, 2018 at 10 AM EST. The exciting relaunch of this work group will focus on the current set of Imaging Performance Metrics to determine if any modifications or additions need to be made. MCC Ambassador Ciaran Cooper will help facilitate the work group and lead the review of the Imaging Performance Metrics survey results.

MCC Imaging Performance Work Group members will work collaboratively to review, revise and add to existing Imaging Performance Metrics to develop best current practices for today’s clinical trial environment, while anticipating the requirements of the near future.

Some deliverables of the Imaging Performance Work Group will be:

  • A newly revised set of imaging metrics that accommodates current industry practices, technologies and regulatory requirements
  • High-level process maps showing imaging vendor oversight metrics
  • Critical Success Factors and Key Performance Indicators
  • Guidance on implementation
  • Recommendations for further exploration and development

The Imaging Performance Work Group meets the third Thursday of the month at 10 AM EST. Those interested in joining the work group should log into their member account and select “Imaging Performance Work Group” in their user profile. Contact work group facilitator Ciaran Cooper or MCC Customer Service for more information.

Click here for more information on the Imaging Performance Work Group.

Take the Imaging Survey

MCC Risk Assessment and Mitigation Management Tool Ready for Update

Thursday, February 22, 2018

It is time to review and update the MCC Risk Assessment and Mitigation Management Tool v1.0 (RA&MMT) that was launched in 2015 and uses definitions from the publicly available RACT tool (TransCelerate Biopharma) along with a number of additional features.

The MCC is seeking feedback from all who have seen or used RA&MMT to further develop, improve and update the tool to align with ICH E6 (R2). The survey will take less than 10 minutes to complete and all responses will remain confidential

MCC member organizations are invited to join the MCC Study Quality Trailblazer Work Group at a meeting on March 14, 2018 to review the results and help develop the updated tool. Log in to the member portal on the MCC website and click on the Study Quality Trailblazer Work Group link to register.

Take the survey Here

Invest in Quality First vs. Fixing Problems Later with MCC’s Cost of Poor Quality Estimator Tool

Saturday, February 10, 2018

A complimentary White Paper detailing the MCC Cost of Poor Quality Estimator Tool (CoPQ) is now available to download. Developed with input from the MCC Study Quality Trailblazer Group members, the CoPQ Tool provides a way to quantify the impact quality-related problems have on operational costs and study timelines.

The White Paper details how the work group’s focus was on the costs of internal failure, such as the cost of avoidable protocol amendments, non-enrolling sites and non-core procedures. Estimating the costs of important errors occurring prospectively can aid in the implementation of prevention and appraisal measures up front, and in providing cost justification for those measures.

The MCC CoPQ Tool is an easy-to-use Excel®-based tool and has three categories for cost of poor quality: direct, operational costs (16 items), operational cost of study extension and delay to market costs.

The CoPQ Tool will be prominently featured at SCOPE when Linda Sullivan, MCC Co-Founder & President, participates in a panel discussion around finding a balance between investing in quality and the cost of fixing quality problems. If you are attending SCOPE, Linda invites you to connect with her!

MCC Cost of Poor Quality Estimator Tool is available to all MCC member organizations. MCC representatives are invited to log in to the MCC Member Portal to download the toolkit.

Download White Paper

Download Presentation Slides

Time to Assess MCC’s Cardiac Safety (ECG) Metrics

Tuesday, February 6, 2018

MCC is seeking survey feedback to determine if the current set of Cardiac Safety (ECG) Metrics are keeping pace with changes in technology and industry practices.

Survey participants will be asked to provide input on MCC Cardiac Safety (ECG) Performance Metric v2.0 descriptions. The metrics will be presented in two sets; metrics related to the Setup and Relationship between Sponsor and Core Lab, and metrics related to the Sample Collection, Overread and Data Management.

All suggestions will serve as a reference for a formal working group that decides upon any changes to the metrics.

Thank you for taking the time to provide us with your feedback. Your survey responses will remain confidential.


Data Management/Biostatistics Work Group Seeking Feedback on How to Revise Current Metrics

With the adoption of ICH E6 (R2) and recent advances in drawing data together across systems, the MCC’s Data Management/Biostatistics Work Group sees the opportunity to renew and revise the current MCC metrics. The work group has created a survey to obtain feedback from organizations – whether members of MCC or not – on the proposed industry standard metrics such as:

  • Are they valuable?
  • Are they used?
  • How easy are they to calculate?

There is a 12-minute webinar introducing the survey here and a complimentary White Paper available on the MCC website describing how the metrics were developed.

You will be asked to provide input on any or all of the 26 metrics. MCC wants to understand whether the metrics are being measured currently, are easy to report and are (or could be) useful. The survey will take less than 15 minutes to complete

Survey participants will receive an executive summary of results once the survey is closed and will be informed when the metrics are published.

Thank you for taking the time to provide us with your feedback. Your survey responses will remain confidential.

MCC’s Protocol Operational Complexity Scoring Tool White Paper

Friday, February 2, 2018

Metrics Champion Consortium recently published a complimentary White Paper discussing its Protocol Operational Complexity Scoring Tool.

The Protocol Operational Complexity Scoring Tool White Paper provides a description of the tool’s developmental approach and explains how the tool works. Developed by the MCC Study Quality Trailblazer Work Group after realizing there was a lack of tools to assess protocol complexity, the tool to assess protocol operational complexity from the study, site and subject perspectives.

Read about the benefits of the MCC Protocol Operational Complexity Scoring Tool:

  • Identify and address complexity to subjects, sites and study before protocol approval
  • Increase likelihood of successful implementation of a protocol
  • Potentially reduce study timelines
  • Decrease burden on sites and study subjects
  • Allow fair comparisons of performance data between studies and sites
  • Improve the richness of data for site selection

Download the complimentary White Paper

Learn more about the MCC Study Quality Trailblazer Work Group


MCC Ambassador Keith Dorricott to Lead Workshop at the eXL 2nd European Clinical Quality Oversight Forum

Thursday, February 1, 2018

MCC is excited to have a presence at the eXL 2nd European Clinical Quality Oversight Forum, in London, when Keith Dorricott, MCC Ambassador, co-leads the preconference workshop. The workshop is titled: Aligning to ICH E6 R2: Identifying Critical Variables, Assessing Risk and Defining Control Measures for Aligning With ICH E6 R2 and is on Monday, February 26, 2018 from 8:30 AM –Noon.

Keith and Tammy Finnigan (COO, Triumph Research Intelligence) will work through the practicalities of determining critical data in a protocol, identifying and evaluating the associated risks and ways to control the risks. They will be using ICH E6 (R2) 5.0 Quality Management as the guide.

Keith and Tammy will be providing an approach to each of the steps along with background and examples, such as using the bow-tie analysis to demonstrate how risk events, causes, consequences, preventions and contingencies tie together. The workshop will involve participants working together through a mock protocol with guidance from the workshop leads.

Participants will have the opportunity to share their knowledge and learn from others on aspects of the practical implementation of Quality Management.

For more information or if you would like to connect with Keith, email him at keith@dorricottmpi.com.