Central Lab Work Group Work members — including representatives from sponsors, central labs, CROs and subject matter experts worked collaboratively to review, revise and add to the MCC’s Lab Performance Metrics 2.1, issued in 2014. The MCC Central Lab Metric Toolkit 3.0 represents a major upgrade from version 2.1. The revised metric set includes 31 metrics definitions — a substantial increase from the 12 metrics in the previous version. Additionally, five tools were developed to guide organizations through the metric selection process.
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.
MCC Central Lab Metric Toolkit v3.0
|Metric Toolkit Overview and Implementation Guide||Document providing an overview of the Metrics Toolkit and recommended approaches for selecting metrics for your program|
|Metric Toolkit Overview (Recorded Webinar)||To provide 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 Map with Metrics||To show the location of the MCC metrics in relation to the high level process — All metrics, portfolio, study, site and KRIs|
|Metrics Workbook||To define each metric. Includes purpose, recommended usage, target, glossary and process map|
|Metric Selection & Implementation Support Tools*|
|Tool A: Key Performance Questions to Metrics||To determine recommended metrics and data elements that help you answer for key performance questions|
|Tool B: Issues to Metrics||To determine recommended metrics and data elements for particular issues|
|Tool C: Basic/Advanced Metrics to Data Elements||To select basic vs advanced metrics and determine data elements needed to calculate selected metrics|
|Tool D: Data Elements to Metrics||To determine metrics available with a given set of data elements|
|Tool E: Metrics Reporting Planning Worksheet||For use between sponsor, CRO and other vendors. Specifies metrics to be used along with reporting frequency and responsibilities|
*Each tool has a short associated “How-To-Use” demo.
MCC member organizations can download the MCC Central Lab Metric Toolkit 3.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.
- Central Lab Work Group explored the following topics:
- Potential impact of ICH E6 (R2) on the overall process, how success is defined and the most important performance questions that can be answered with metrics.
- Broadening the scope of the metrics to consider how data might be used to assist in the overall Quality Risk Management of clinical trials.
- Defining metrics at different levels – portfolio, study and site – to more clearly delineate between metrics for vendor oversight versus metrics for study oversight and monitoring of site risk.
- Existing performance metrics developed by the MCC that could be used, possibly with modification.
Looking for additional information?
Those interested in joining the work group should log into their member account and select Central Lab Work Group in their user profile. For additional information about joining the Central Lab 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.
Download White Paper
MCC Central Lab Metric Toolkit v3.0*
- Metrics Toolkit Overview and Implementation Guide
- Metric Toolkit Overview (Recorded Webinar)
- Process Map with Metrics
- Metrics Workbook
Metric Selection & Implementation Support Tools:
- Tool A: Key Performance Questions to Metrics
- Tool B: Issues to Metrics
- Tool C: Basic/Advanced Metrics
- 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 the MCC Central Lab LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.