MCC Centralized & Site Monitoring Process Metrics work group members are working to define process metrics as this area has been transformed by Risk-Based Quality Management. Our industry survey has shown that the most common process metrics used in this area are based on traditional site monitoring. We are exploring how centralized, targeted and remote monitoring have impacted the process as we develop a high-level process map and glossary of terms. We are also discussing the challenges in the new process and the key performance questions we need answers to, to help monitor, manage and improve the process. Our revised and new metrics will be designed to help answer those key performance questions. As with all MCC metric sets, they will be developed as part of a toolkit designed to help select the right metrics, to implement and to use metrics. We launched the work group in October at a meeting with over 20 organizations represented – sponsors, CROs and vendors. A 13-minute video summary from the launch meeting is available to view on this page. The development effort will continue in to 2020.
Note that there are separate monthly meetings for the Centralized Monitoring Best Practice Community where members discuss case studies and SME presentations on topics of interest in Centralized and Risk-Based Monitoring.
3rd Thursday of the month, 11am – 12pm ET. Registration links available on the Upcoming Meetings webpage in the MCC Member Portal.
- Centralized and Site Monitoring Metrics Work Group is exploring the following topics:
- The process of site monitoring – including on-site and central
- Perspectives of member organizations on the important questions the metrics should answer (Key performance Questions)
- Metrics for site monitoring – both on-site and centralized
- Metrics at site, country, study and portfolio levels
- Metrics for timeliness and quality as well as for cycle time
Centralized and Site Monitoring Process Metrics Toolkit v1.0
|Metrics Toolkit Overview and Implementation Guide||Provide an overview of the Metrics Toolkit and recommended approaches for selecting metrics for your program|
|Metric Toolkit Overview (Recorded Webinar)||Provide the purpose of the metrics and how to use the toolkit components – including demonstrations of the Metric Workbook and Metric Selection and Implementation Tools.|
|Process Maps||Show the types and locations of metrics in relation to the high-level process|
|Metrics Workbook||Describe each metric in detail – including purpose, recommended usage, calculation formula, performance target(s), glossary and other details|
|Metric Implementation Support Tools:|
|Tool A: Key Performance Questions to Metrics||Determine recommended metrics that help you answer key performance questions|
|Tool B: Issues to Metrics||Determine recommended metrics for particular issues|
|Tool C: Basic/Advanced Metrics to Data Elements||Select metrics based on metric category (basic/advanced/aspirational) and determine data elements needed to calculate selected metrics|
|Tool D: Data Elements to Metrics||Identify metrics you can calculate with a given set of data elements|
|Tool E: Metrics Reporting Planning Worksheet||Establish reporting expectations including key performance questions to be answered, metric formulas, reporting frequency and responsibilities|
MCC member organizations can download the MCC Centralized and Site Monitoring Process Metric Toolkit v1.0 by logging into the member portal and visiting the MCC metrics sets and tool page. Contact MCC Customer Service if you need assistance.
Looking for additional information?
Those interested in joining the work group should log into their member account and select Centralized and Site Monitoring Process Metrics Work Group in their user profile. For additional information about joining the Centralized and Site Monitoring Process Metrics 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.
Metric Info Sheet → DOWNLOAD
MCC Centralized & Site Monitoring Process Metrics Toolkit v1.0*
- 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
Episode19: Optimizing Clinical Trial Monitoring with Keith Dorricott and Linda Sullivan
Join Our LinkedIn Community
Employees of MCC member organizations are invited to join the MCC Centralized and Site Monitoring/RBM LinkedIn Community to get the latest news on work group activities, share relevant news and participate in online discussions.