CPCD case studies
CPCD · Put your knowledge to work in context.
The Certified Professional in Clinical Data Management (CPCD) is a professional credential for people who run the data side of clinical trials: data managers, clinical data coordinators, database builders, and the programmers and monitors who work alongside them. It signals that a practitioner can take a study from protocol to locked database while keeping the record defensible under GCP and applicable regulatory expectations. The CPCD case studies are 5 cases and about 2,211 words.
1Conflicting Eligibility Criteria at Screening
A Phase II oncology study has inclusion criterion 3: 'Absolute neutrophil count (ANC) ≥1.5 × 10^9/L within 7 days before first dose.' The site screens a patient on 1 June. The local lab reports ANC 1.6 × 10^9/L on 28 May.
449 words, about 2 min2CRF Design for a Complex Dosing Regimen
A Phase I study uses a dose-escalation design with three dosing schedules: once daily (QD), twice daily (BID), and three times daily (TID). The protocol allows dose modifications at the investigator's discretion, including dose reduction, interruption, and re-escalation.
422 words, about 2 min3Query Management for a High-Volume Site
A Phase III cardiovascular outcomes trial has 200 sites. Site 101 has enrolled 45 subjects and has 312 open queries, the highest of any site.
450 words, about 2 min4SAE Reconciliation Discrepancy
During SAE reconciliation for a Phase II study, the data manager compares the clinical database SAE log with the safety database. The clinical database has 23 SAEs; the safety database has 25.
462 words, about 2 min5Database Lock Readiness with Outstanding Issues
A Phase III study is scheduled for database lock in 10 days. The data manager runs a readiness report and finds: 12 open queries (8 for missing lab dates, 4 for inconsistent AE terms), 3 subjects with missing primary endpoint data, 2 SAE reconciliation discrepancies, and 5 protocol deviations not yet coded.
428 words, about 2 min