MCC Data Management and Biostatistics Work Group

The MCC Data Management and Biostatistics Work Group developed the MCC Data Management, Biostatistics & Medical Writing Metric Toolkit v2.0 after conducting a comprehensive review of the metrics in the original MCC Clinical Trial Performance metric set v1.2. The 26-metric toolkit was updated to follow the regulatory change with ICH E6 (R2) and to keep pace with the industry trend for system integration that has made it easier to combine data and calculate new, insightful metrics. The updated metric set includes new metrics that focus on critical data and measure missing data.

Meeting Schedule

The work group has moved into the Implementation Support stage of the metric set life-cycle. Online meetings will be held on a quarterly basis to provide MCC members the opportunity to ask questions and share experiences related to implementing the metric set. Registration links are available on the Upcoming Meetings Webpage in the MCC Members Portal.

Team Output:

Component Purpose
At-A-Glance Short document providing an overview of the MCC DM/Bios/MW Toolkit v2.0
MCC DM/Bios/MW Toolkit v2.0 Overview (Recorded Webinar and Slides) Provides an overview of the purpose of the metrics and how to use the toolkit. Includes demonstrations of the Metric Workbook and Metric Selection Tools.
Process Maps Provides a listing of the metrics shown on a high-level process map
Metrics Workbook Contains metric definitions, purpose, recommended usage, target, glossary and process map
Metric Implementation Support Tools:
Tool 1: Metrics to Data Elements To determine data elements needed to calculate specific metrics
Tool 2: Data Elements to Metrics To determine metrics available with a given set of data elements

MCC member organizations can download the MCC Data Management, Biostatistics & Medical Writing Metric Toolkit v2.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.

Team Explored:

  • The impact of ICH E6 (R2) on Data Management and Biostatistics metrics.
  • Data Management and Biostatistics metrics developed previously by the MCC and any updates / modifications needed.
  • The opportunity to measure new metrics using data from separate systems that industry members are now able to consider due to system integrations.
  • Establishing a “basic” metric set that can be used by most organizations and a more “advanced” metric set that can be adopted by organizations with more advanced systems and experience using metrics.

 

Looking for additional information?

Those interested in joining the work group should log into their member account and select Data Management and Biostatistics Work Group in their user profile. For additional information about joining the Data Management and Biostatistics Work Group, please contact Customer Service at customerservice@metricschampion.org.

MCC Membership Information

This is a member-only group. For additional information about MCC membership options or to find out if your organization is a MCC member, please visit the MCC Membership webpage or contact MCC Director of Membership, Teresa Holland or call 317-622-0266, ex.108. Contact Linda Sullivan to discuss additional study team-related details. Return to Work Group List

 

MCC Data Management, Biostatistics & Medical Writing Toolkit v2.0*

  • Toolkit At-A-Glance
  • Toolkit Overview Recorded Webinar and Slides
  • Process Maps
  • Metrics Workbook
  • Metric Implementation Support Tools:

  • Tool 1: Metrics to Data Elements
  • Tool 2: Data Elements to Metrics

*Available to MCC Member Organizations. For more information on membership options contact Membership Director Terry Holland.

 

Join Our LinkedIn Community

Employees of MCC member organizations are invited to join MCC Data Management and Biostatistics LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.