Clinical Trial Complexity Measure – Balancing Constraints to Achieve Quality

With limited clinical research funding, it is imperative that costs associated with clinical research studies be transparent and measureable to ensure optimal use. The Pediatric Ontario (Oncology) Protocol Assessment Level (Peds-OPAL) provides a mechanism to assess research coordinator workload, a significant component of a clinical research study budget by measuring study complexity. Reflecting research practices congruent with the International Conference on Harmonization Good Clinical Practices, the Peds-OPAL scoring instrument affords investigators and project managers the ability to assess impact on trial quality in relation to ­constraints of time, cost and scope.