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 MCC Data Management and Biostatistics Work Group developed the toolkit after conducting a comprehensive review of the metrics in the original MCC Clinical Trial Performance metric set v1.2. The updated metric set includes new metrics that focus on critical data and measure missing data.
The toolkit includes:
- A detailed description of the 26 metrics, including performance targets
- An At-A-Glance document providing an overview of the MCC Data Management, Biostatistics and Medical Writing Metrics
- A recorded webinar that reviews the purpose of the metrics and provides an overview of how to use the toolkit
- Process maps to provide a listing of the metrics shown on a high-level process map
- Metric selection tools to determine metrics to data elements and data elements to metrics
MCC Member organizations can download the MCC Data Management, Biostatistics and Medical Writing Metrics Toolkit v2.0 by visiting the MCC metrics sets and tool page.
Learn more about the MCC Data Management and Biostatistics Work Group.
Not a member? Contact Terry Holland, MCC Membership Director, to discuss membership options.