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
When drafting a research protocol for IRB submission, which section must explicitly describe procedures to minimize risk to participants?
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.
A PI discovers mid-project that a key co-investigator has left the institution. What is the MOST important immediate step?
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.
Which document serves as the primary legal agreement defining the responsibilities between a sponsor and a research institution?
Answer: Clinical Trial Agreement (CTA)
A Clinical Trial Agreement (CTA) is the binding contract between sponsor and institution outlining financial, regulatory, and operational responsibilities.
During the planning phase, a PI should establish a Data Safety Monitoring Board (DSMB) primarily for which type of trial?
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.
A PI receives NIH funding. Within how many days must an Invention Disclosure typically be submitted after a new discovery is made?
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.
Which planning tool is MOST useful for identifying the sequence and dependencies of project tasks in a complex research study?
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.
A PI plans a multi-site study. Which step is ESSENTIAL before any site can begin enrolling participants?
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.