CRNO study plan

Map the ICH-GCP E6(R2) principles to the CRNO exam's Domain 1 blueprint, listing each principle and where it appears in site-level work.

Define the roles of sponsor, CRO, site investigator, sub-investigator, and study coordinator, and state who holds which regulatory responsibility.

Identify the FDA regulations and guidance documents that govern clinical research conduct (21 CFR Parts 50, 56, 312, and 812) and summarize each part's scope in one sentence.

Explain the difference between a clinical trial, a registry, and a chart review, and classify five short scenarios by study type.

Distinguish the Common Rule (45 CFR 46) from FDA human-subject regulations and list three practical differences that affect site operations.

Describe the purpose and process of IRB review, including initial, continuing, and amendment review, and identify what triggers each.

Outline the elements of a protocol deviation versus a protocol violation and determine which requires IRB reporting.

Explain how the Declaration of Helsinki and CIOMS guidelines inform GCP and where they diverge from FDA requirements.

Break down the standard sections of a protocol (objectives, endpoints, eligibility, randomization, safety monitoring, statistics) and state what a coordinator must verify in each.

Compare Phase I through Phase IV designs and match each phase to its typical site workload.

Define primary, secondary, and exploratory endpoints and identify the endpoint type in three sample protocols.

Explain randomization, blinding, and control-arm design and describe how each affects day-to-day site procedures.

Describe how sample size, power, and interim analysis plans influence enrollment targets and monitoring frequency.

Draft a recruitment plan that names at least three channels, a budget assumption for each, and a metric to track channel yield.

Write prescreening scripts and eligibility checklists for an inclusion/exclusion list of 15 criteria.

Explain how to document screening failures and screen failures versus enrollment failures per ICH-GCP and site SOP.

Calculate enrollment rate, screen failure rate, and time-to-target from a sample recruitment log.

Describe strategies to recruit underrepresented populations while avoiding coercive or misleading outreach.

List the required elements of informed consent under 21 CFR 50.25 and identify which elements are missing from a sample consent form.

Explain the consent process for vulnerable populations, including children, cognitively impaired adults, and non-English speakers, and describe when a short form and interpreter are used.

Describe how to document consent, re-consent after amendments, and consent of legally authorized representatives.

Distinguish informed consent from assent and from authorization for use of protected health information.

Identify common consent deficiencies cited in inspections and describe how to prevent each.

Plan a study visit schedule that maps each protocol-required assessment to its source document and window.

Describe source documentation standards (ALCOA+) and apply them to correct five poorly written source entries.

Explain investigational product accountability from receipt through dispensing, reconciliation, and destruction, including temperature excursion handling.

Describe device accountability for investigational devices, including tracking, calibration records, and return or disposal.

Identify what constitutes an unblinding event and describe the documentation required when it occurs.

Define adverse event, serious adverse event, suspected unexpected serious adverse reaction, and unanticipated problem, and classify 10 sample events correctly.

Describe the site's SAE reporting timeline and workflow, including who notifies the sponsor, IRB, and FDA and within what timeframe.

Explain causality assessment and severity grading and apply both to three case vignettes.

Describe source-to-EDC data flow, query resolution, and the role of the data manager and medical coder.

List the records a site must retain, the retention period, and the process for archiving and destroying records.

Describe the purpose and conduct of site initiation, routine monitoring, and close-out visits and what a coordinator prepares for each.

Explain how to prepare for an FDA inspection, including the inspection logistics, document requests, and staff roles.

Identify common audit and inspection findings across all domains and match each to the domain it most affects.

Complete a timed 60-question mixed-domain practice set and review every missed item to its source regulation or guidance.