CPI Cheat Sheet 2026

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

1. Why is it important for investigators to report adverse events? → To ensure patient safety and make necessary adjustments
2. What is the purpose of randomization codes or the randomization list in a clinical trial? → To assign subjects to treatment arms in an unpredictable manner to minimize selection bias
3. What is a statistical test used for in clinical research? → To assess if findings are significant and generalizable
4. What is a clinical endpoint? → A measure used to assess the outcome of treatment
5. What is scope creep in CPI project management? → Uncontrolled scope expansion without adjusting time, cost, or resources
6. What is a near-miss report in CPI practice? → Documentation of an event that could have caused harm but did not
7. Who is primarily responsible for reporting SAEs to the clinical trial sponsor? → The principal investigator or sub-investigator at the site
8. What is evidence-based practice in CPI Pharmacology & Medication Management? → Integrating research evidence with expertise and client needs
9. What does residual risk mean in CPI practice? → Risk remaining after all controls are implemented
10. At what reading level should informed consent documents ideally be written, per FDA and OHRP guidance? → 8th grade or below
11. What is a records management audit in CPI? → Reviewing practices to ensure compliance with policies
12. What is a needs assessment in CPI Infection Control & Prevention practice? → Identifying gaps between current conditions and desired outcomes
13. What is the role of the FDA in clinical trials? → To ensure safety and approval of new drugs
14. Why is regular review important in CPI risk management? → Conditions change and new risks emerge requiring updates
15. What is the importance of continuing education for CPI professionals in Pharmacology & Medication Management? → Maintaining current knowledge and adapting to industry changes
16. What is the role of ethics in clinical research? → To ensure respect for participants and follow safety protocols
17. What does SUSAR stand for in clinical trial safety reporting? → Suspected Unexpected Serious Adverse Reaction
18. What is quantitative data in clinical research? → Numerical measurements used for statistical analysis
19. What is peer review in CPI Patient Assessment & Evaluation? → Quality evaluation by qualified colleagues for improvement
20. What is the importance of informed consent in clinical research? → To ensure participants understand the study and risks involved
21. What is a cohort study? → A study that tracks people over time
22. What is evidence-based practice in CPI Infection Control & Prevention? → Integrating research evidence with expertise and client needs
23. What role do standard operating procedures play in CPI Patient Assessment & Evaluation? → Ensuring consistency and quality through documented instructions
24. Why is accurate documentation important in CPI? → It supports decision-making, compliance, and legal defensibility
25. What is a risk matrix used for in CPI practice? → Evaluating risks by plotting likelihood against impact severity
26. Which population requires special additional protections for informed consent under Subpart B of 45 CFR Part 46? → Pregnant women, fetuses, and neonates
27. What is a work breakdown structure in CPI practice? → Hierarchical decomposition of deliverables into manageable work packages
28. What is peer review in CPI Infection Control & Prevention? → Quality evaluation by qualified colleagues for improvement
29. What are the five process groups in CPI project management? → Initiating, Planning, Executing, Monitoring & Controlling, Closing
30. What are Good Clinical Practice (GCP) guidelines? → Guidelines for ethical and scientific conduct in clinical trials