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. Which federal regulation requires IRBs to assess whether risks to participants are minimized and reasonable in relation to anticipated benefits? → 45 CFR Part 46
2. What is a KPI in CPI quality management? → A measurable value showing how effectively objectives are achieved
3. A PI must ensure that all team members complete required human subjects training. This requirement stems primarily from: → The Common Rule (45 CFR 46) and federal funding agency requirements
4. 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
5. In a crossover trial, the 'washout period' serves to: → Eliminate carryover effects from prior treatment
6. Which of the following best describes a 'pragmatic' clinical trial? → Real-world conditions testing whether a treatment works in practice
7. A PI discovers that a subject's cell phone records contradict witness statements. How should this discrepancy be addressed in the report? → Present both sources objectively and note the contradiction without drawing conclusions
8. The term 'effect modification' (interaction) in epidemiology refers to: → The exposure-outcome relationship differing across strata of another variable
9. A PI's study involves a Unanticipated Problem Involving Risks to Subjects (UPIRSO). The report to the IRB should typically be submitted within: → 10 business days
10. Which element is most critical when communicating study risks to participants during the informed consent process? → Presenting risks in plain language at an appropriate reading level
11. What are consequences of non-compliance in CPI practice? → Fines, license revocation, legal liability, and reputation damage
12. What is a communication plan in CPI project management? → Defining what information is shared, with whom, when, and how
13. When a quality indicator trend shows increasing protocol deviation rates over three consecutive months, the FIRST appropriate step is to: → Conduct a root cause analysis
14. 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
15. 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
16. Which of the following is the primary purpose of an independent Data and Safety Monitoring Board (DSMB)? → Periodically review unblinded data to recommend stopping or continuing the trial
17. A Pareto chart is most useful in quality improvement when you need to: → Identify which few categories account for most of the quality problems
18. Which open-source tool is widely used by investigators to recover deleted files from digital storage media? → Autopsy
19. Which of the following populations is considered 'vulnerable' and requires additional protections under federal regulations? → Pregnant women, prisoners, and children
20. A PI is responsible for ensuring that all financial conflicts of interest (FCOI) related to the research are disclosed to which entity? → The institution's designated official and ultimately the federal funding agency
21. Which communication strategy best supports participant retention throughout a longitudinal study? → Sending regular newsletters or updates about study progress
22. 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
23. Facilities and Administrative (F&A) costs are recovered by the institution to cover which type of expenses? → Overhead costs such as building maintenance and utilities
24. A report contains hearsay information that could not be independently verified. The BEST practice is to: → Label it clearly as unverified and note the source
25. A PI is preparing a final report for an attorney client. Which element is MOST critical to include for court admissibility purposes? → Chain of custody documentation
26. A researcher discovers mid-study that a database field was miscoded for 15% of participants. What is the most appropriate first step? → Document the error and assess its impact on study outcomes
27. A sponsor requests that a site re-enter all CRF data because the original EDC vendor changed. What is the key data integrity requirement? → Ensure the transferred data matches source documents and original entries exactly
28. Which financial management principle requires that expenditures on a grant be reasonable, allocable, and consistent with the project's scope? → Cost allowability standards under 2 CFR 200
29. A Zelen design in clinical trials is characterized by: → Randomization before consent, with consent only for the intervention group
30. During the planning phase, a PI should establish a Data Safety Monitoring Board (DSMB) primarily for which type of trial? → Randomized controlled trials with significant safety endpoints