CPI Project Planning & Execution 2

Question 1

When drafting a research protocol for IRB submission, which section must explicitly describe procedures to minimize risk to participants?

Accepted Answer

Risk-benefit analysis

Answer

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?

Accepted Answer

Submit a protocol amendment to the IRB

Answer

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?

Accepted Answer

Clinical Trial Agreement (CTA)

Answer

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?

Accepted Answer

Randomized controlled trials with significant safety endpoints

Answer

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?

Accepted Answer

60 days

Answer

Most institutional technology transfer policies require inventors to disclose discoveries within 60 days of conception to comply with Bayh-Dole Act obligations.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Project Planning & Execution 2