Version 2.0 of MCC’s Protocol Development Quality Scoring Tool launches today!

Monday, December 8, 2014

Version 2.0 of MCC’s Protocol Development Quality Scoring Tool launches today! All MCC members are invited to attend a webinar noon-1 p.m. EST to learn how their protocol development process could be improved using this new tool. (The webinar will be posted and available for viewing after its conclusion.)


The Microsoft Excel®-based tool provides protocol development teams with a set of questions for reviewers to consider in the protocol review process and a means to score (1) protocol design quality, (2) protocol feasibility quality and (3) editorial quality.


The tool generates four scores: an overall score and three sub-scores (design, feasibility and editorial quality), that provide the development team a means to check whether the protocol is ready for approval. Each score reflects how well these aspects of protocol composition and review were conducted: Who should have participated in composition/review vs. those that did participate?; What was the nature/quality of their contributions?; What proportion of the critical review elements/questions were considered by each reviewer, and how thoroughly and were data applied?;  and Did the protocol development team incorporate/address reviewer comments?


Ultimately, the tool helps sponsors gain approval of quality protocols that can be successfully executed with few, if any, amendments.


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