Quality-by-Design: Assessing Study, Site and Patient Burden with the Protocol Operational Complexity Scoring Tool

The MCC Protocol Operational Complexity Scoring Tool provides the means to quantify subject, site and study team operational burdens. The tool can be used during protocol design to highlight areas of operational complexity so opportunities to reduce that complexity can be implemented before protocol approval resulting in:

  • Increased likelihood of successful implementation of a protocol
  • Reduced study timelines
  • Decreased burden on sites and study subjects.

Additionally, the tool can be used to assess study, site and subject level operational complexity burden at study close, providing essential metadata measurements to enable fair comparison of performance data across studies. Download the paper to learn more.