The Four Elements—Toward a Harmonised Recruitment Tracking

About this session

Recruitment performance is a critical determinant of clinical trial timelines, yet current approaches to assessing delays—primarily comparing planned versus actual randomisations—lack a consistent framework to explain why deviations occur. Root cause analysis is often fragmented, as each stage of the process is measured in different units, from country and site activation to screening and randomisation. This paper introduces CSSR, a standardised analytical framework that decomposes recruitment into four key drivers: Clinical Trial Applications (C), site initiations (S1), screening/informed consent (S2), and randomisations (R). CSSR translates the impact of each stage into a common metric—days gained or lost—using defined formulas and algorithms based on planned and actual milestones. By harmonising how recruitment performance is measured and communicated, CSSR enables clearer root cause analysis, improves transparency, and supports more informed decision-making across clinical trial stakeholders.

Speaker

• FB

  Frank M Berger

  Expert, Data & Analytics Solutions · Boehringer Ingelheim Pharma GmbH & Co KG

  Speaker