CRNO study guide
CRNO · Work through your exam, one topic at a time.
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 study guide has 9 sections and about 4,122 words.
01Clinical Research Foundations and Regulatory Framework
This domain tests whether you can name which rule governs a situation - not just recall acronyms. Items combine ICH GCP principles, US FDA regulations, the Common Rule, and the division of responsibility between sponsor, investigator, IRB/IEC and monitor.
479 words, about 2 min02Study Design and Protocol Development
This domain asks whether you can read a protocol critically: is the question answerable, does the endpoint actually measure the objective, and is the design protected against bias? Questions frequently hinge on the difference between an objective and an endpoint, on why a particular control or blinding level was chosen, and on whether the sample size justification is coherent.
449 words, about 2 min03Patient Recruitment, Screening, and Enrollment
This domain tests the practical pipeline: how participants are found, how eligibility is proven from source documents, and at what moment a person formally becomes a study participant. Items often present a borderline candidate - a lab value one decimal outside the range, a washout period not quite complete - and ask what the coordinator may do next.
461 words, about 2 min04Informed Consent and Participant Protection
This domain tests consent as a regulated process rather than a signature. Items ask which elements must appear, who may sign, when re-consent is required, and what extra safeguards apply to children, prisoners, pregnant women and adults with impaired decision-making capacity.
447 words, about 2 min05Study Conduct, Visits, and Data Collection
This domain covers the day-to-day conduct of a visit: doing only what you are trained and delegated to do, performing assessments inside the protocol window, capturing source contemporaneously, and handling anything that departs from plan. Questions usually present a common friction point - a late visit, a missed assessment, a task performed by an undelegated staff member.
478 words, about 2 min06Investigational Product and Device Management
This domain tests custody of the investigational product and the study device: receipt, storage, dispensing, return, destruction, blinding, and the paperwork that proves all of it. Items often hinge on a temperature excursion, a kit-number mismatch, or an unblinding that was not medically necessary.
427 words, about 2 min07Safety Reporting and Adverse Event Management
This domain tests the definitions and clocks that decide whether an event becomes an expedited report. Most errors come from confusing severity with seriousness, or from assuming the site decides what gets reported to the regulator.
442 words, about 2 min08Data Management, Source Documentation, and Recordkeeping
This domain tests whether the data can survive a monitor's review and an inspector's questions years later. Items focus on what counts as source, how corrections are made, how eCRF data are controlled, and how long records must be kept and made available.
485 words, about 2 min09Monitoring, Audits, Inspections, and Quality Management
This domain tests whether you understand who is watching, against what standard, and what happens after findings. Items contrast a sponsor's monitoring visit or audit with a regulatory inspection, and then ask for an appropriate corrective and preventive action rather than a vague promise to retrain.
454 words, about 2 min