CPI Project Planning & Execution 2 — Questions and Answers
Question 1: When drafting a research protocol for IRB submission, which section must explicitly describe procedures to minimize risk to participants?
- Budget justification
- Risk-benefit analysis (Correct answer)
- Investigator qualifications
- Sponsor contact information
Correct answer: Risk-benefit analysis
The risk-benefit analysis section must explicitly outline procedures to minimize participant risk and demonstrate that potential benefits outweigh those risks.
Question 2: A PI discovers mid-project that a key co-investigator has left the institution. What is the MOST important immediate step?
- Submit a protocol amendment to the IRB (Correct answer)
- Halt all research activities indefinitely
- Notify the funding sponsor only
- Replace the co-investigator without documentation
Correct answer: Submit a protocol amendment to the IRB
A personnel change on a study requires an IRB amendment so oversight bodies can assess whether the change affects the safety or integrity of the research.
Question 3: Which document serves as the primary legal agreement defining the responsibilities between a sponsor and a research institution?
- Informed consent form
- Clinical Trial Agreement (CTA) (Correct answer)
- Data safety monitoring board charter
- Investigator brochure
Correct answer: Clinical Trial Agreement (CTA)
A Clinical Trial Agreement (CTA) is the binding contract between sponsor and institution outlining financial, regulatory, and operational responsibilities.
Question 4: During the planning phase, a PI should establish a Data Safety Monitoring Board (DSMB) primarily for which type of trial?
- Retrospective chart reviews
- Randomized controlled trials with significant safety endpoints (Correct answer)
- Single-arm observational studies
- Survey-based social science research
Correct answer: Randomized controlled trials with significant safety endpoints
DSMBs are required primarily for randomized controlled trials where interim safety data must be reviewed by an independent body.
Question 5: A PI receives NIH funding. Within how many days must an Invention Disclosure typically be submitted after a new discovery is made?
- 7 days
- 30 days
- 60 days (Correct answer)
- 90 days
Correct answer: 60 days
Most institutional technology transfer policies require inventors to disclose discoveries within 60 days of conception to comply with Bayh-Dole Act obligations.
Question 6: Which planning tool is MOST useful for identifying the sequence and dependencies of project tasks in a complex research study?
- SWOT analysis
- Gantt chart with task dependencies (Correct answer)
- RACI matrix
- Fishbone diagram
Correct answer: Gantt chart with task dependencies
A Gantt chart with dependencies visually maps task sequences and identifies the critical path, essential for complex multi-phase research projects.
Question 7: A PI plans a multi-site study. Which step is ESSENTIAL before any site can begin enrolling participants?
- Enroll at least 10 participants at the lead site first
- Obtain local IRB approval or cede review at each participating site (Correct answer)
- Complete 50% of data collection at the coordinating center
- Publish a preliminary abstract about the study design
Correct answer: Obtain local IRB approval or cede review at each participating site
Each participating site must have documented IRB approval (or formal ceding of review to a central IRB) before enrollment can begin at that location.
CPI Project Planning & Execution 2
When drafting a research protocol for IRB submission, which section must explicitly describe procedures to minimize risk to participants?