CCRC case studies
CCRC · Put your knowledge to work in context.
The Certified Clinical Research Coordinator (CCRC®) credential is offered through the Association of Clinical Research Professionals (ACRP), a non-profit founded in 1976 whose stated mission is to promote excellence in clinical research. ACRP describes its certification as the most widely recognized benchmark of excellence in clinical research competency, and reports a member community of more than 22,000 clinical research professionals across the globe. The CCRC® is aimed at coordinators and site-level research staff who manage day-to-day study conduct - participant recruitment and consent, protocol adherence, source documentation, investigational product accountability, regulatory binders, and IRB communication - and at those seeking recognition, advancement, or expanded responsibility. The exam is built from a Job Task Analysis (JTA). The CCRC case studies are 5 cases and about 2,943 words.
1Washout Window Under Enrollment Pressure
A phase II rheumatoid arthritis trial is screening Mr. D, a 57-year-old man with a 6-year history of seropositive RA.
650 words, about 3 min2Turning 18 During an Amendment Re-Consent
A 16-year-old, Maya, enrolled 5 months ago in a pediatric asthma trial. Her mother signed the parental permission form and Maya signed the assent form.
593 words, about 3 min3Refrigerator Excursion Before a Scheduled Dose
A phase III placebo-controlled trial of a weekly injectable for type 2 diabetes stores prefilled pens at 2-8°C, protected from light. On Saturday, a 3.5-hour power outage caused the site pharmacy refrigerator to reach 1.2°C; the data logger shows the pens never went above 8°C.
568 words, about 3 min4Infusion Reaction and Emergency Unblinding
During a phase III double-blind trial of an intravenous monoclonal antibody for severe asthma, Subject 2117 develops stridor, diffuse urticaria, and hypotension (82/50 mmHg) about 10 minutes into the first infusion. The investigator gives intramuscular epinephrine, stops the infusion, and starts oxygen and fluids.
572 words, about 3 min5Recruitment, Privacy, and Undue Influence
A site is recruiting for a 12-week trial of a new antidepressant in adults with major depressive disorder. The PI is a psychiatrist who treats most participants in the same clinic.
560 words, about 3 min