CPI Communication & Stakeholder Relations 2

Question 1

An IRB requests additional clarification on a protocol amendment. What is the PI's most appropriate first step?

Accepted Answer

Provide a written response addressing each IRB concern specifically

Answer

The PI should respond in writing to each IRB concern directly and specifically to facilitate timely resolution.

Question 2

Which communication strategy best supports participant retention throughout a longitudinal study?

Accepted Answer

Sending regular newsletters or updates about study progress

Answer

Regular study updates and newsletters keep participants engaged and reduce dropout rates in longitudinal studies.

Question 3

A sponsor requests interim data before the scheduled interim analysis. How should the PI respond?

Accepted Answer

Consult the data safety monitoring board and protocol before sharing

Answer

Unscheduled data sharing must be evaluated against protocol terms and DSMB oversight to protect trial integrity.

Question 4

A study team member disagrees with the PI's decision about a protocol deviation. What is the recommended approach?

Accepted Answer

The PI should discuss the concern privately, document the decision rationale, and allow escalation through institutional channels if unresolved

Answer

Open discussion, documented rationale, and established escalation pathways support both team communication and compliance.

Question 5

When must a PI communicate a serious adverse event (SAE) to the sponsor?

Accepted Answer

Within the timeframe specified in the protocol, typically 24–72 hours

Answer

Protocol-specified timeframes for SAE reporting to sponsors are mandatory and typically require expedited reporting within 24–72 hours.

(CPI) Certified Principal Investigator Practice Test