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. What is a KPI in CPI quality management? → A measurable value showing how effectively objectives are achieved
2. Which type of recruitment material typically requires IRB review and approval before it can be used to solicit study participants? → Study advertisements or flyers posted publicly or distributed to potential subjects
3. What are consequences of non-compliance in CPI practice? → Fines, license revocation, legal liability, and reputation damage
4. What is a communication plan in CPI project management? → Defining what information is shared, with whom, when, and how
5. When obtaining consent from a non-English-speaking participant, what is required? → A translated consent form or short form with interpreter, approved by the IRB
6. What is the primary purpose of a monitoring visit conducted by a sponsor's Clinical Research Associate (CRA)? → To verify data accuracy, protocol compliance, and participant safety at the site
7. Which of the following populations is considered 'vulnerable' and requires additional protections under federal regulations? → Pregnant women, prisoners, and children
8. What is the minimum required element that must be included in every informed consent document? → A description of the purposes, risks, and benefits of the research
9. What does benchmarking mean in CPI quality improvement? → Comparing performance against recognized standards of excellence
10. What is 'continuing review' as it relates to IRB oversight of an ongoing study? → Periodic re-evaluation of the study to ensure ongoing protection of participants
11. What is a near-miss report in CPI practice? → Documentation of an event that could have caused harm but did not
12. What is a compliance audit in CPI practice? → A systematic review verifying adherence to requirements and policies
13. What is a CPI professional's obligation regarding confidentiality? → Protecting client information and disclosing only with authorization or legal requirement
14. What is the required action when a site staff member who has delegated study responsibilities leaves the institution? → Update the delegation log, retrain a replacement, and notify the sponsor/CRO
15. What does residual risk mean in CPI practice? → Risk remaining after all controls are implemented
16. What is multi-factor authentication in CPI security? → Requiring two or more verification factors for access
17. Why is regular review important in CPI risk management? → Conditions change and new risks emerge requiring updates
18. Which of the following subject retention strategies is considered ethically acceptable in a long-term clinical trial? → Providing reasonable reimbursement for travel and time at each scheduled visit
19. Why is written communication important in CPI practice? → It creates permanent records and ensures clarity for future reference
20. Why is documentation important in CPI technology? → It ensures knowledge transfer, troubleshooting, and operational continuity
21. A sponsor's monitor requests access to participant medical records to verify source data. What must the PI ensure is in place before allowing this access? → A signed authorization or HIPAA waiver permitting data access for monitoring purposes
22. What is root cause analysis in CPI quality assurance? → Investigating to find the fundamental underlying cause of a problem
23. What does data integrity mean in CPI practice? → Accuracy, consistency, and reliability of data throughout its lifecycle
24. Which of the following research activities qualifies as 'exempt' from full IRB review under 45 CFR 46.104? → Research involving educational tests with no identifiable information
25. What does professional competency require of a CPI practitioner? → Maintaining current knowledge through continuing education
26. What is an SLA in CPI technology? → A formal agreement defining expected service performance standards
27. What differentiates quality assurance from quality control in CPI? → QA prevents defects through processes; QC detects defects in outputs
28. Before enrolling a subject from a vulnerable population such as prisoners, the PI must ensure that: → The IRB-required additional safeguards for that population are in place
29. Which federal regulation requires that the selection of research subjects be equitable and give appropriate consideration to vulnerable populations? → 45 CFR Part 46 (The Common Rule)
30. How should CPI professionals handle difficult conversations? → Prepare key points, remain calm, focus on facts, seek solutions