CRA (OPS) study guide
CRA · Work through your exam, one topic at a time.
The Clinical Research Associate (CRA) certification is a professional credential for monitors who oversee clinical trials at investigative sites on behalf of sponsors and contract research organizations. It signals that a monitor can independently verify that a study is conducted according to protocol, good clinical practice, and applicable regulations, and that subject rights and data integrity are protected. The CRA study guide has 8 sections and about 2,738 words.
01Ethical and Regulatory Foundations of Clinical Research
Clinical research rests on a layered rulebook, and exam questions love the seams between the layers. Know the lineage: Nuremberg Code → Declaration of Helsinki → Belmont Report (respect for persons, beneficence, justice) → ICH E6 Good Clinical Practice → national law.
318 words, about 2 min02Study Preparation and Site Qualification
Before a protocol can be executed, the sponsor must determine whether a site can and will perform it. Know the documents: protocol and investigator's brochure (or package insert), feasibility questionnaire, site selection and pre-study (qualification) visit report, investigator CV and medical licences, Form FDA 1572 for IND studies, financial disclosure, laboratory certifications and normal ranges, and the site's IRB and contract status.
346 words, about 2 min03Site Initiation and Study Start-up
The site initiation visit (SIV) converts a selected site into an enrolling site. No study activity - screening, consenting or IP receipt - may occur until the required pre-requisites are in place: written IRB/IEC approval of the current protocol and consent, executed contract, complete regulatory documents, and trained staff.
323 words, about 2 min04Monitoring Visits and Source Data Verification
Monitoring is the sponsor's quality-control function, executed by the CRA under a written plan. ICH E6 5.18 lists what a monitor verifies: investigator qualifications and resources, protocol compliance, informed consent for every subject, accuracy and completeness of source and CRF data, safety reporting, IP accountability, and facilities.
341 words, about 2 min05Safety Reporting and Adverse Event Management
Safety is where terminology precision decides the answer. Sort the concepts: an adverse event is any untoward medical occurrence, whether or not related to the investigational product.
340 words, about 2 min06Investigational Product Accountability and Handling
Investigational product (IP) is the sponsor's property held in trust by the site, and the paper trail must reconcile to the unit. Under 21 CFR 312.61 the investigator may administer IP only to subjects under their supervision, and may not supply it to anyone not authorised.
328 words, about 2 min07Data Management and Query Resolution
Data management is a GCP activity, not an administrative afterthought. The CRF (paper or electronic) captures data that must be traceable to source, and ICH E6 defines source data as all information in original records and certified copies from which the data derive.
373 words, about 2 min08Study Close-out, Documentation, and Records Retention
Close-out confirms that obligations are discharged and the record is complete. At the close-out visit the CRA verifies final IP accountability and destruction or return, outstanding queries and data lock readiness, final SAE reconciliation, device return, notification of the IRB, resolution of all open action items, and storage arrangements for records.
369 words, about 2 min