Protocol Operational Complexity Scoring Tool

NEWS: The MCC Study Quality Trailblazer Group met on 13-Nov-2019 to discuss use of the tool and possible updates. The discussion included the increasing interest across the industry in measuring protocol complexity and how the MCC tool can help. We considered how to develop a score from 1-100 in addition to a complexity rating of high/moderate/low. We also discussed splitting the scientific/protocol elements from the operational elements. These enhancements will help teams identify draft protocols with high burden scores that could benefit from gathering input from patient advisory boards, investigator sites and other partners. The tool revisions support the tracking of the impact of protocol modifications resulting from actions taken based on the input. The draft version of the tool is in development and will serve as the foundation for the group to build version 2.0 to be released in Q1 2020.

Members can register for upcoming meetings by visiting the Study Quality Trailblazer page on the MCC member website or contacting Lara Knitter, MCC Customer Service & Product Support, at for assistance.


The MCC Study Quality Trailblazer Work Group was formed in 2016 as a collaborative group to work on metrics and tools. The aim is to demonstrate that investing time and resources up front can yield higher quality clinical study performance at a lower cost than fixing quality issues during the study.The MCC Study Quality Trailblazer Group has developed an easy-to-use, Excel®-based tool that enables users to assess operational complexity of implementing a particular protocol and scores each protocol as a low, moderate or high. This is determined from the perspective of patients, sites and the study. It pulls from public sources – such as reports on the impact of the number of unique procedures in a protocol – and knowledge of MCC member organizations.


  • Identify and address complexity to patients, sites and study before protocol approval
  • Increase likelihood of successful implementation of a protocol
  • Potentially reduce study timelines
  • Decrease burden on sites and study patients
  • Allow fair comparisons of performance data between studies and sites
  • Improve the richness of data for site selection

How it works

The tool includes 20 elements from Vendors and Lab Sampling to Visit Burden and Patient Population. Each element is linked to one or more of the patient, site and study dimensions of operational complexity. Visit Burden, for example, is linked to patient, site and study whereas Vendors is linked only to the study dimension. The user scores each element for a particular protocol implementation as low, moderate or high complexity. There is guidance to help determine the level for each element. The tool uses these scores to provide an overall score for the protocol in the three dimensions.

Representatives of MCC member organizations are invited to log in to the MCC site to download the tool.

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