CRA Cheat Sheet 2026

The 30 highest-yield CRA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Which of the following is a fundamental principle of ich-gcp compliance as it applies to Certified Research Associate? → Systematic evaluation and adherence to established industry standards
2. Under Accelerated Approval, what post-market commitment is required of the sponsor? → Completing confirmatory trials to verify clinical benefit
3. What should a site do upon receiving investigational product with visibly damaged or compromised packaging? → Document the damage, quarantine the product, and notify the sponsor
4. What is the significance of data analysis in research? → To convert raw data into meaningful conclusions.
5. Which quality assurance method is most commonly applied in ich-gcp compliance to verify that CRA professional standards are being met? → Structured audits, peer reviews, and performance metrics aligned with industry benchmarks
6. What is the primary ethical obligation of a CRA professional when a conflict of interest arises during phase i-iv clinical trials activities? → Disclose the conflict to all relevant parties and recuse from the decision if necessary
7. What is the role of appendices in research reports? → To provide supplementary material such as raw data and additional tables.
8. A CRA professional encounters an unfamiliar situation while performing ich-gcp compliance duties. What is the most appropriate first action? → Consult relevant standards, guidelines, or a qualified supervisor before proceeding
9. During drug reconciliation, what accounting equation is the CRA verifying? → IP received = IP dispensed + IP on hand + IP returned or destroyed
10. What is the first step in research design? → To define the research question and objectives.
11. An Investigational New Drug (IND) application must be submitted to the FDA before which activity can begin? → Phase I human clinical trials
12. What is the purpose of conducting a literature review in research? → To identify gaps in research and provide context.
13. What is plagiarism in research? → Misrepresenting someone else's work as your own.
14. Which section of 21 CFR Part 312 defines the sponsor's obligation to monitor the progress of all clinical investigations? → 21 CFR 312.56
15. Which of the following is a fundamental principle of biostatistics & hypothesis testing as it applies to Certified Research Associate? → Systematic evaluation and adherence to established industry standards
16. Under ICH E6(R2) GCP guidelines, who must be authorized to access investigational product at a clinical site? → Only individuals formally authorized and listed on the site delegation log
17. Which quality assurance method is most commonly applied in irb & informed consent to verify that CRA professional standards are being met? → Structured audits, peer reviews, and performance metrics aligned with industry benchmarks
18. What is the role of ethics in research? → To ensure the well-being and rights of research participants.
19. Which FDA pathway is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need? → Fast Track Designation
20. What is an abstract in scientific research? → A summary of the research paper, including methods and results.
21. Which section of a New Drug Application (NDA) contains clinical study reports and individual patient data? → Module 5 — Clinical Study Reports
22. What is the difference between qualitative and quantitative research? → Qualitative research explores experiences; quantitative research measures variables.
23. Which of the following is a fundamental principle of quantitative & qualitative methods as it applies to Certified Research Associate? → Systematic evaluation and adherence to established industry standards
24. What are the consequences of unethical research practices? → Unethical practices can lead to harm, legal issues, and loss of credibility.
25. Under 21 CFR Part 312, how long must a sponsor retain IND records after the drug is no longer under investigation? → 2 years
26. What is the role of control groups in experimental research? → To compare the effects of the experimental treatment.
27. Which quality assurance method is most commonly applied in phase i-iv clinical trials to verify that CRA professional standards are being met? → Structured audits, peer reviews, and performance metrics aligned with industry benchmarks
28. Under FDA regulations, what must a sponsor do if a clinical study is discontinued? → Notify the FDA in writing within 30 days
29. What is an 'emergency code break' in the context of a blinded clinical trial? → Unblinding a subject's treatment assignment for medical management
30. Who is authorized to dispense investigational product to study subjects at a clinical trial site? → Only authorized pharmacy or designated licensed personnel per site SOPs and protocol