1 | Exam Basics
- Format: 125 multiple-choice questions.
- Duration: 3 hours.
- Domains:
- Scientific Concepts & Design
- Ethical & Participant Safety
- Regulatory Requirements
- Clinical Trial Operations (GCP)
- Study & Site Management
- Data Management & Quality
- Passing: ≈ 70 %
- Prereq: 3 000 hours of CRA-task experience.
2 | Week-by-Week 8-Week Plan
| Weeks | Focus | Key Tasks |
|---|---|---|
| 1–2 | Ethics + GCP | Read ICH E6(R2); make flashcards for terms like monitoring plan and source data verification. |
| 3 | Scientific Design | Review study phases, randomization, risk-based monitoring. |
| 4 | Regulatory | Summarize 21 CFR Parts 50, 54, 56, 312, 812. |
| 5–6 | Operations + Data Quality | Read ICH E8(R1), E9; practice queries and audit trail cases. |
| 7 | Mock Exams | Do 2× full-length tests under timed conditions. |
| 8 | Final Review | Revisit missed topics; sleep and relax before exam day. |
3 | Study Materials
- ACRP Exam Blueprint PDF
- ICH E6(R2), E8(R1), E9 guidelines
- FDA CFR Parts 50 & 312
- ACRP Practice Tests by Clinical Research Exam Prep
4 | Exam-Day Strategy
- Arrive 30 min early.
- Read questions slowly — keywords like “best next step.”
- Use “Flag for Review.”
- Manage time (~1.5 min per question).
- Trust first instincts after thorough review.
5 | After the Exam
- Save results for renewal portfolio.
- Join ACRP community for networking.
- Track CE credits early.
Key Takeaway
A consistent, structured plan + active practice + GCP mastery = success.