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.
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.
|Metrics Toolkit Overview and Implementation Guide||Document provides an overview of the Metrics Toolkit and recommended approaches for selecting metrics for your program|
|Metric Toolkit Overview (Recorded Webinar)||Video provides an overview of purpose of the metrics and how to use the toolkit – includes demonstrations of the Metric Workbook and Metric Selection and Implementation Tools.|
|Process Maps||Visualization of the processes and the process tasks measured by MCC metrics|
|Metrics Workbook||Detailed documentation of the metric definitions, recommended usage, performance targets, glossary of key terms and change log|
|Metric Implementation Support Tools:|
|Tool A: Key Performance Questions to Metrics||Allows you to select metrics based on the key performance questions you seek to answer|
|Tool B: Issues to Metrics||Allows you to select metrics based on the issues you seek to manage|
|Tool C: Basic/Advanced Metrics to Data Elements||Allows you to select metrics based on whether they are the basic ones recommended by the work group or are advanced ones for a deeper dive|
|Tool D: Data Elements to Metrics||Allows you to determine which metrics you could report when you select the data elements you have available|
|Tool E: Metrics Reporting Planning Worksheet||For use between sponsor and CRO. Specifies metrics to be used along with reporting frequency and responsibilities|
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.
- 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 firstname.lastname@example.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. Contact Linda Sullivan to discuss additional study team-related details. Return to Work Group List
MCC Data Management, Biostatistics & Medical Writing Toolkit v2.0*
- Metrics Toolkit Overview and Implementation Guide
- Metric Toolkit Overview (Recorded Webinar)
- Process Maps
- Metrics Workbook
Metric Implementation Support Tools:
- Tool A: Key Performance Questions to Metrics
- Tool B: Issues to Metrics
- Tool C: Basic/Advanced Metrics to Data Elements
- Tool D: Data Elements to Metrics
- Tool E: Metrics Reporting Planning Worksheet
*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.