CCRA study guide
CCRA · Work through your exam, one topic at a time.
The CCRA® - Certified Clinical Research Associate - credential is one of the certification programs offered by the Association of Clinical Research Professionals (ACRP), listed alongside the ACRP-CP®, CCRC®, CPI®, ACRP-MDP®, and ACRP-PM® programs. It is aimed at professionals who monitor and oversee clinical trials at investigator sites: verifying that study conduct, data, and documentation meet the protocol, Good Clinical Practice expectations, and applicable regulatory requirements. The CCRA study guide has 4 sections and about 1,725 words.
01Clinical Research Associate Practice
The Clinical Research Associate Practice domain tests whether you understand the CRA's defined role under ICH GCP and how it differs from the investigator's, the sponsor's, and the auditor's. Questions probe qualification and training requirements, what a monitor may and may not do, and how monitoring findings are documented and escalated.
435 words, about 2 min02Study Conduct and Monitoring
The Study Conduct and Monitoring domain covers the trial lifecycle from feasibility through close-out: how sites are selected, initiated, monitored, and closed, and what the CRA must verify at each stage. Pre-study: confirm the investigator is qualified and has adequate staff, facilities, and access to a suitable subject population (ICH E6 4.1).
428 words, about 2 min03Regulatory and Ethical Requirements
Regulatory and Ethical Requirements tests your command of the rules that make a trial lawful and ethical: ICH GCP, FDA 21 CFR Parts 50, 56, and 312, the Declaration of Helsinki, and privacy law including HIPAA and GDPR. An IRB or IEC must review and approve the protocol, consent form, recruitment materials, and investigator qualifications before enrollment (21 CFR 56.109; ICH E6 3.1).
451 words, about 2 min04Communication and Site Management
Communication and Site Management tests the interpersonal and operational side of monitoring: how a CRA builds a working relationship with a site, documents contact, escalates problems, and drives corrective action without damaging the relationship. Every substantive contact should be documented - a contact report, follow-up letter, or trip report - dated and filed in the trial master file or site file.
411 words, about 2 min