ACRP-CP case studies
ACRP-CP · Put your knowledge to work in context.
The ACRP Certified Professional (ACRP-CP®) is a credential awarded by the Association of Clinical Research Professionals to clinical research professionals who pass a standardized certification exam. ACRP describes it as a mark of excellence recognizing demonstrated proficiency across the diverse roles and functions that make up a clinical study team, which makes it a fit for coordinators, monitors, project managers, regulatory and data staff, and others with broad cross-functional exposure rather than deep specialization in a single job title. The ACRP-CP case studies are 5 cases and about 4,034 words.
1The Interim Analysis Nobody Pre-Specified
A 240-participant Phase 2b trial in moderate-to-severe plaque psoriasis randomizes 1:1 to an investigational IL-23 inhibitor or placebo, with PASI-75 at Week 12 as the primary endpoint. Historical placebo response is 30%; the sponsor assumed 62% on drug and powered at 90% two-sided alpha 0.05.
805 words, about 4 min2A Fatality at the Other Site
A first-in-human Phase 1/2 CAR-T trial at a single academic site enrolls adults with relapsed or refractory B-cell lymphoma. Participant 014, aged 34, is recovering from Grade 3 cytokine release syndrome and Grade 3 immune effector cell-associated neurotoxicity on tocilizumab and dexamethasone.
849 words, about 4 min3Four Findings at a Community Oncology Site
During a routine monitoring visit at a community oncology site enrolling a Phase 3 non-small cell lung cancer trial, you document four findings. Three participants were consented by a board-certified oncologist who is listed as a sub-investigator in the regulatory binder but does not appear on the delegation log and has no documented protocol-specific training.
783 words, about 4 min41,540 Against a 4,000 Milestone
A Phase 3 vaccine trial plans 30 sites and 6,000 participants over 12 months. At Month 9: 12 sites are open, 1,540 participants are enrolled against a 4,000 milestone, screen failure is 41% against the 18% assumed in feasibility, and per-participant payments are triggered only at database lock.
783 words, about 4 min5Three Weeks to Lock
In a 900-participant Phase 3 diabetes trial, the central laboratory transmits HbA1c in NGSP percent while the eCRF field is configured for IFCC mmol/mol; the mapping table was built but never validated. Separately, 14 serious adverse events entered in the safety database have no matching record in the clinical database, and the medical coder has applied MedDRA preferred terms from a newer version than the one specified in the SAP.
814 words, about 4 min