Project Planning & Execution Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Project Planning & Execution flashcards as text
A PI identifies that enrollment is running 30% below target at the halfway point of the study. Which action should be taken FIRST?
Answer: Conduct a root-cause analysis to identify barriers to recruitment
Identifying why enrollment is lagging — whether due to eligibility criteria, referral gaps, or community barriers — is necessary before implementing any corrective strategy.
Which of the following is the BEST indicator that a research project's data quality control plan is functioning effectively?
Answer: Query rates are consistently below 5% with rapid resolution
Low query rates with fast resolution indicate that data are being collected accurately and that discrepancies are identified and corrected promptly.
A protocol deviation occurs when a participant receives an incorrect study drug dose. The PI must report this to the IRB as:
Answer: An unanticipated problem if it unexpectedly increases risk to participants
If a deviation unexpectedly increases risk to participants or affects the integrity of the data, it qualifies as an unanticipated problem and must be reported to the IRB.
During study execution, a monitor (CRA) visits the site and reviews source documents. This process is called:
Answer: Source data verification (SDV)
Source data verification (SDV) is the process by which a clinical research associate compares data entered in the case report form against original source documents to ensure accuracy.
A PI's study involves a Unanticipated Problem Involving Risks to Subjects (UPIRSO). The report to the IRB should typically be submitted within:
Answer: 10 business days
Most IRBs and OHRP guidance require that unanticipated problems be reported within 10 business days of the PI becoming aware of the event.
Which execution strategy best reduces protocol deviations caused by staff turnover on a multi-year study?
Answer: Maintaining a comprehensive, up-to-date study operations manual with regular staff training
A detailed operations manual combined with ongoing training ensures new staff can quickly become proficient and consistent with protocol procedures.
Which metric is MOST directly used to track whether a clinical research project is on schedule?
Answer: Schedule Performance Index (SPI)
The Schedule Performance Index (SPI) compares earned value to planned value, giving a ratio that indicates whether the project is ahead, on, or behind schedule.