CPEDC case studies
CPEDC · Put your knowledge to work in context.
The Certified Professional in Electronic Data Capture (CPEDC) is a vendor-neutral credential for people who build, run, and defend the systems that collect clinical trial data. Candidates are typically clinical data managers, EDC study builders, database programmers, and clinical systems or quality specialists who want their practical EDC knowledge recognized in a form employers and sponsors can evaluate consistently. The CPEDC case studies are 5 cases and about 2,558 words.
1The Late-Arriving Site and the Frozen Database
A Phase III oncology study reached its last-patient-last-visit on 14 March. The data management plan states the database will be soft-locked (data entry still permitted, queries active) for 30 days, then hard-locked for statistical analysis.
545 words, about 3 min2Mid-Study Edit Check That Would Re-Open 400 Queries
Six months into a 24-month Phase II study, the sponsor's medical monitor notices that a lab value (serum creatinine) is being entered in µmol/L by some sites and mg/dL by others - the CRF field has no unit control. Of 1,200 entered lab records, roughly 400 are suspected to be in the wrong unit.
492 words, about 2 min3The Shared Login at a High-Enrolling Site
During remote monitoring review, the CRA notices that 38 CRF pages at Site 07 were entered within a 2-hour window on a Sunday, all under the username 'site07 coord'. The site has three coordinators and one PI.
488 words, about 2 min4The Migration That Broke the Audit Trail
A sponsor is migrating an ongoing study from EDC Vendor A to Vendor B because Vendor A is sunsetting its platform. The migration plan extracts 85,000 records and loads them into Vendor B.
511 words, about 3 min5The Query That Was Closed Without an Answer
A data review of 60 open queries at a site shows that 14 were closed by the site coordinator with the response 'data correct as entered' but the flagged value was not changed and no supporting comment was added. The CRA's monitoring report from the prior month had already noted the same 14 values as 'to be verified against source.' The values in question are adverse event start dates that precede the informed consent date for 9 subjects.
522 words, about 3 min