CCRA Study Guide 2026
Everything you need to pass the CCRA exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 CCRA Exam Format at a Glance
📚 CCRA Topics to Study (33)
✍️ Sample CCRA Questions & Answers
1. A sponsor-CRA learns that an investigator has not reported a serious adverse event (SAE) to the IRB within the required timeframe. What must the CRA do?
The CRA must document the deviation, remind the investigator of their reporting obligation, and escalate to sponsor management as specified in the monitoring plan.
2. Dosage and safety (Find out how the medicine affects human metabolism and pharmacology).
The primary purpose of a Phase 1 clinical study is to evaluate the safety of a new drug, determine a safe dosage range, and identify potential side effects. These studies also investigate the drug's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) in humans. This initial phase helps establish the drug's basic profile in humans.
3. What does the term 'source document verification (SDV)' refer to in clinical monitoring?
SDV is the process of comparing data recorded in the CRF against original source documents to ensure data accuracy and integrity.
4. A subject's source document shows a glucose value of 450 mg/dL, but the CRF records 45 mg/dL. How should this discrepancy be handled?
Transcription errors between source documents and CRFs must be resolved through a formal data query so the correction is auditable.
5. Which organization administers the CCRA certification examination in the United States?
ACRP (Association of Clinical Research Professionals) administers the CCRA certification exam and sets the competency standards for clinical research associates.
6. When investigational product is returned from a site for destruction, the CRA must confirm:
Returned IP must be documented with quantities matching records, properly labeled, and accompanied by return authorization documentation; this ensures full accountability and proper destruction.