The Protocol Development Scoring Tool (ProDevST) is a Microsoft Excel®-based tool that provides protocol development teams with a set of questions for reviewers to consider in the protocol review process and a means to score:
- protocol design quality
- protocol feasibility quality
- editorial quality
How it Works
This Microsoft Excel®-based tool includes quality review questions and a proprietary algorithm designed to assess the protocol process and generate scores based on scientific design, feasibility and editorial quality to address potential problems before the protocol is approved.
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. Ultimately, the tool helps sponsors gain approval of quality protocols that can be successfully executed with few, if any, amendments. MCC members are invited to log onto the member area and download the scoring tool toolkit.
- Identify and address issues before protocol approval
- Reduce overall complexity and re-work efforts
- Prevent costly “avoidable” amendments
- Decrease burden on sites and study subjects
- Improve timelines and study outcomes