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 ICH-GCP principle requires that each individual involved in conducting a trial be qualified by education, training, and experience? → Principle of qualified personnel
2. Which qualitative method involves the researcher immersing themselves in a community to observe behavior in its natural context? → Ethnography
3. In a Phase I dose-escalation study, what is the primary purpose of a 'sentinel dosing' strategy? → To administer the dose to one or two subjects first before dosing the rest of the cohort
4. What is the primary purpose of source data verification (SDV) during a monitoring visit? → To confirm that data in the CRF accurately reflects original source records
5. Which regulatory document specifically addresses the use of electronic records and electronic signatures in clinical trials conducted in the US? → FDA 21 CFR Part 11
6. Which of the following is an example of the 'respect for persons' principle from the Belmont Report? → Allowing competent adults to make autonomous decisions about participation
7. 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
8. Under Accelerated Approval, what post-market commitment is required of the sponsor? → Completing confirmatory trials to verify clinical benefit
9. Which federal regulation specifically governs the protection of human subjects in research funded by U.S. federal agencies? → 45 CFR Part 46 (The Common Rule)
10. A DOI (Digital Object Identifier) in a reference list serves primarily to: → Provide a persistent, unique link to the cited article
11. When two independent reviewers disagree on study inclusion in a systematic review, the recommended resolution method is: → Discussion until consensus or third-reviewer arbitration
12. 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
13. What is the significance of data analysis in research? → To convert raw data into meaningful conclusions.
14. 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
15. 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
16. A sponsor asks a CRA to backdate a source document to align with the protocol timeline. The CRA should: → Refuse and report the request as a potential GCP violation
17. What is the role of appendices in research reports? → To provide supplementary material such as raw data and additional tables.
18. 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
19. During drug reconciliation, what accounting equation is the CRA verifying? → IP received = IP dispensed + IP on hand + IP returned or destroyed
20. Under ICH E6(R2), how long before a trial begins should the investigator obtain IEC/IRB approval? → Written approval must be obtained prior to initiating the trial
21. Which data collection method is most susceptible to social desirability bias? → Self-report questionnaires
22. What is the first step in research design? → To define the research question and objectives.
23. An Investigational New Drug (IND) application must be submitted to the FDA before which activity can begin? → Phase I human clinical trials
24. Which of the following is an advantage of telephone interviewing over mail surveys? → Higher response rates and ability to probe answers
25. When an IRB reviews a consent form and finds it uses highly technical language at a graduate reading level, the primary ethical concern is: → Participants may not truly understand what they are consenting to, undermining autonomy
26. The Cochrane Risk of Bias tool (RoB 2) assesses bias across which domain specific to randomization? → Bias arising from the randomization process
27. In ethnographic research, the primary data collection method is: → Participant observation
28. In a study with 80% power, what is the probability of committing a Type II error? → 0.20
29. An IRB is composed of 10 members. A quorum is present when at least how many members are present, and what additional requirement must be met? → A majority (at least 6) must be present, including at least one nonscientist member
30. A moderating variable is one that: → Changes the direction or strength of the relationship between two other variables