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.