MCC Releases Protocol Operational Complexity Tool

Wednesday, December 20, 2017

Carmel, IN – MCC’s Study Quality Trailblazer Work Group is excited to release its first iteration of the MCC Protocol Operational Complexity Tool. It is designed to assign an operational complexity rating at subject, site and study levels.

“I have often wondered about the reliability of comparing performance between studies and sites using historical metrics but not taking account of the study operational complexity,” said Linda Sullivan, MCC Co-founder & President who launched the MCC Study Quality Trailblazer Work Group in 2016. “In discussions with member organizations, we thought there would be real value in developing a tool to assess operational complexity. Taking complexity into account means better metric comparisons and ultimately better decisions on site selection, comparisons between CROs and Sponsors, and on subject burden, which impacts recruitment and retention.”

The Protocol Operational Complexity Tool will:

  • Help determine an operational complexity rating based on the protocol and implementation
  • Generate a rating for subject, site and study
  • Allow organizations to focus on elements that are contributing to operational complexity to determine if actions can be taken to reduce that complexity

The tool is designed in Excel to be simple to use. It provides guidance on rating of each of the complexity elements. The complexity elements are aligned with the TransCelerate Risk Assessment and Categorization Tool (RACT).

View the webinar on the MCC website. Members can view the full webinar and toolkit by logging into their MCC user accounts.

For more information please contact Keith Dorricott or Linda Sullivan.


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Jane Jones
MCC Markeing Manager
(317) 622-0266 ext. 110