CRNO case studies
CRNO · Put your knowledge to work in context.
The CRNO is a certification examination for clinical research nurses and other research professionals who coordinate and deliver care to study participants. It is aimed at nurses working in clinical research settings - investigational sites, academic research centres, and hospital research units - who want to demonstrate competence across the full trial lifecycle rather than in a single task. The CRNO case studies are 5 cases and about 2,987 words.
1Consent Documentation and Re-Consent After a Mid-Study Amendment
At a monitoring visit for a Phase II rheumatoid arthritis trial, the CRA reviews consent documents for eight enrolled participants. Three consent forms lack the signature of the person obtaining consent.
591 words, about 3 min2Febrile Neutropenia in a Blinded Trial: SAE Reporting and Unblinding
An 18-site Phase III double-blind trial is evaluating an investigational oral JAK inhibitor in adults with moderate-to-severe ulcerative colitis. A 42-year-old participant randomized 5 weeks ago calls the research nurse reporting fever of 39.1°C, sore throat, and painful oral ulcers that began 3 days ago.
720 words, about 4 min3Screening Pressure in a Phase I Healthy Volunteer Cohort
A Phase I first-in-human study in healthy volunteers is enrolling a cohort of 12. On Thursday, a 29-year-old applicant presents for screening.
538 words, about 3 min4Temperature Excursion and a Already-Dosed Participant
At a satellite clinic, the research pharmacist receives a shipment of 24 kits of an investigational monoclonal antibody for a Phase II asthma study. The data logger inside the shipment shows a 5-hour excursion to 31.2°C during transit; the label requires storage at 2–8°C and says 'do not freeze.' The pharmacist quarantines the shipment but notices that two kits from the same lot had already been transferred to the clinic's refrigerator the previous week and one was dispensed to a participant, who received the first subcutaneous dose yesterday.
563 words, about 3 min5Source-to-ECRF Discrepancies Before a Sponsor Audit
During a routine monitoring visit for a Phase III hypertension trial, the CRA compares five subject files with the eCRF. In subject 014, the source note from visit 3 documents 'mild headache since Tuesday, no medication, resolved' but the eCRF has 'no adverse events.' The visit date in the eCRF is 12 June; the source note is dated 14 June.
575 words, about 3 min