Latest SCDM CCDM Practice Questions BY Clark

To monitor site variability in eligibility screening, you must analyze the number of subjects screened versus the number of subjects enrolled at each site. This allows identification of sites that are over- or under-screening relative to their enrollment yield.

The GCDMP (Chapter: Data Quality Assurance and Metrics) emphasizes that screening-to-enrollment ratios are 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 reveal screening efficiency or variability, which depend on both screening and enrollment data.

Thus, option B correctly 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