Protocol Quality Metrics Working Group

white paper
The MCC Protocol Quality Metrics Working Group conducted a “gap-analysis” of the MCC Protocol Quality Scoring Tool (v1) and the protocol-related metrics in the MCC Clinical Trial Performance Metric set (v1.2). The Working Group determined that both the tool and the metrics needed to be updated to align with current industry practices.


Working Group output that is available to members:

  • Protocol Development Scoring Tool (ProDevST) – A tool for assessing the quality of the protocol while the protocol is still in development. This provides an opportunity to improve the quality prior to its release.
    • Scoring Tool Instructions.
    • Blank version of the scoring tool
    • Example version with mock data are available
    • Protocol Editorial, Feasibility, and Scientific Reviewer Scoring Sheets
  • Protocol Development Scoring Tool White Paper – An overview and the value a protocol assessment tool with an objective rating scale can bring to raising the quality of a portfolio of studies.
  • Recorded launch session that introduces the tool
  • Protocol Quality Metric set that align with the ProDevST sections

MCC members should contact Customer Service ( for assistance accessing the information on the MCC Member Portal.

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