Thebest methodto identify sites withhigh subject attritionis to calculate theproportion of patients for which two visit periods have passed without data, by site.
According to theGCDMP (Chapter: Data Quality Assurance and Control), subject attrition is an important performance indicator for data completeness and site compliance. Evaluating missing or delayed data acrossmultiple consecutive visit periodsallows for early detection of potential dropouts or site-level operational issues.
By assessing this proportion at thesite level, the Data Manager can distinguish between random missing data and systematic site underperformance. Counting or proportioning late visits (options B and C) identifies scheduling delays, not attrition. Looking at missing data without site context (option D) fails to identify site-specific patterns, limiting corrective action.
This metric aligns withrisk-based monitoring (RBM)practices recommended byICH E6 (R2)andFDA RBM Guidance, which promote proactive identification of sites at risk of data loss.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 5.4 – Site Performance Metrics
ICH E6 (R2) Good Clinical Practice, Section 5.18 – Monitoring and Site Performance Evaluation
FDA Guidance for Industry: Oversight of Clinical Investigations – Risk-Based Monitoring, Section 6 – Site Performance Metrics
