Which data are needed to monitor site variability in eligibility screening?

To monitorsite variability in eligibility screening, you must analyzethe number of subjects screenedversusthe number of subjects enrolledat each site. This allows identification of sites that are over- or under-screening relative to their enrollment yield.

TheGCDMP (Chapter: Data Quality Assurance and Metrics)emphasizes thatscreening-to-enrollment ratiosare critical indicators of protocol compliance and data quality. Sites with unusually low conversion rates may have unclear understanding of inclusion/exclusion criteria, requiring targeted training or monitoring.

Other options (A, C, D) provide enrollment metrics but do not revealscreening efficiency or variability, which depend on bothscreening and enrollment data.

Thus,option Bcorrectly identifies the data necessary for monitoring eligibility screening performance across sites.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Quality Assurance and Metrics, Section 5.4 – Site Performance Metrics

ICH E6(R2) GCP, Section 5.18 – Monitoring and Site Oversight Requirements