CPI Communication & Stakeholder Relations 2 — Questions and Answers
Question 1: An IRB requests additional clarification on a protocol amendment. What is the PI's most appropriate first step?
- Resubmit the entire protocol from scratch
- Provide a written response addressing each IRB concern specifically (Correct answer)
- Request a meeting with the IRB chair to negotiate
- Withdraw the amendment and proceed with the original protocol
Correct 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.
Question 2: Which communication strategy best supports participant retention throughout a longitudinal study?
- Limiting contact to required study visits only
- Sending regular newsletters or updates about study progress (Correct answer)
- Delegating all participant communication to research coordinators
- Avoiding communication between visits to prevent bias
Correct answer: Sending regular newsletters or updates about study progress
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?
- Share the data immediately to maintain the sponsor relationship
- Consult the data safety monitoring board and protocol before sharing (Correct answer)
- Refuse all sponsor data requests outside the protocol
- Share only aggregate data without individual records
Correct 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.
Question 4: A study team member disagrees with the PI's decision about a protocol deviation. What is the recommended approach?
- The team member should document the disagreement and escalate to the IRB immediately
- The PI should discuss the concern privately, document the decision rationale, and allow escalation through institutional channels if unresolved (Correct answer)
- The PI should reassign the team member to avoid conflict
- The team member should comply without documentation
Correct 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.
Question 5: When must a PI communicate a serious adverse event (SAE) to the sponsor?
- Within 30 days of occurrence
- Within the timeframe specified in the protocol, typically 24–72 hours (Correct answer)
- At the next scheduled monitoring visit
- Only if the event is deemed related to the investigational product
Correct 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.
Question 6: A key opinion leader collaborating on a study suggests a change that could benefit their own institution financially. What should the PI do?
- Implement the change if it is scientifically valid
- Evaluate the suggestion and require disclosure of the financial interest before proceeding (Correct answer)
- Decline all suggestions from collaborators with financial ties
- Report the collaborator to the IRB without discussion
Correct 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.
Question 7: Which element is most critical when communicating study risks to participants during the informed consent process?
- Using technical medical terminology to ensure precision
- Presenting risks in plain language at an appropriate reading level (Correct answer)
- Emphasizing benefits over risks to encourage enrollment
- Reading the consent form aloud without allowing questions
Correct 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.
CPI Communication & Stakeholder Relations 2
An IRB requests additional clarification on a protocol amendment.
What is the PI's most appropriate first step?