Communication & Stakeholder Relations 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 Communication & Stakeholder Relations flashcards as text
An IRB requests additional clarification on a protocol amendment. What is the PI's most appropriate first step?
Answer: Provide a written response addressing each IRB concern specifically
The PI should respond in writing to each IRB concern directly and specifically to facilitate timely resolution.
Which communication strategy best supports participant retention throughout a longitudinal study?
Answer: Sending regular newsletters or updates about study progress
Regular study updates and newsletters keep participants engaged and reduce dropout rates in longitudinal studies.
A sponsor requests interim data before the scheduled interim analysis. How should the PI respond?
Answer: Consult the data safety monitoring board and protocol before sharing
Unscheduled data sharing must be evaluated against protocol terms and DSMB oversight to protect trial integrity.
A study team member disagrees with the PI's decision about a protocol deviation. What is the recommended approach?
Answer: The PI should discuss the concern privately, document the decision rationale, and allow escalation through institutional channels if unresolved
Open discussion, documented rationale, and established escalation pathways support both team communication and compliance.
When must a PI communicate a serious adverse event (SAE) to the sponsor?
Answer: Within the timeframe specified in the protocol, typically 24–72 hours
Protocol-specified timeframes for SAE reporting to sponsors are mandatory and typically require expedited reporting within 24–72 hours.
A key opinion leader collaborating on a study suggests a change that could benefit their own institution financially. What should the PI do?
Answer: Evaluate the suggestion and require disclosure of the financial interest before proceeding
Conflicts of interest must be disclosed and managed transparently before any decisions are made based on biased input.
Which element is most critical when communicating study risks to participants during the informed consent process?
Answer: Presenting risks in plain language at an appropriate reading level
Federal regulations require that consent information be presented in language understandable to the participant, not in scientific jargon.