CPI Communication & Stakeholder Relations 3 — Questions and Answers
Question 1: A regulatory authority conducts an unannounced site inspection. What is the PI's immediate priority?
- Request a 48-hour delay to organize records
- Greet the inspector, verify credentials, and notify the institution's regulatory affairs office (Correct answer)
- Consult legal counsel before speaking with the inspector
- Provide only verbal summaries of records to avoid misinterpretation
Correct answer: Greet the inspector, verify credentials, and notify the institution's regulatory affairs office
Verifying inspector credentials and promptly notifying institutional regulatory affairs ensures proper handling of unannounced inspections.
Question 2: A PI is co-authoring a publication with a sponsor employee. Which communication practice is essential?
- Allowing the sponsor employee to draft all sections for efficiency
- Ensuring all authors meet authorship criteria and that sponsor involvement is disclosed (Correct answer)
- Excluding the sponsor employee from the author list to avoid bias perception
- Submitting the manuscript before sharing it with the sponsor
Correct answer: Ensuring all authors meet authorship criteria and that sponsor involvement is disclosed
ICMJE authorship criteria must be met by all listed authors, and sponsor involvement must be transparently disclosed.
Question 3: Which approach best manages community stakeholder expectations when conducting research in a vulnerable population?
- Providing community leaders with preliminary results before peer review
- Engaging community advisors early in study design and maintaining ongoing dialogue throughout the research (Correct answer)
- Limiting community involvement to recruitment activities only
- Reporting findings to the community only after publication
Correct answer: Engaging community advisors early in study design and maintaining ongoing dialogue throughout the research
Community-based participatory research principles call for early and sustained engagement with community stakeholders to build trust and relevance.
Question 4: A participant contacts the PI directly after receiving their test results, seeking medical advice beyond the study scope. How should the PI respond?
- Provide the requested medical advice to maintain the therapeutic alliance
- Acknowledge the participant's concern, clarify the PI's role, and refer them to their primary care provider (Correct answer)
- Ignore the request to maintain research objectivity
- Notify the IRB before responding to the participant
Correct answer: Acknowledge the participant's concern, clarify the PI's role, and refer them to their primary care provider
The PI must clarify the boundary between research and clinical care and facilitate appropriate referral without abandoning the participant.
Question 5: What is the primary purpose of a clinical trial agreement (CTA) in sponsor-PI communications?
- To define publication rights, financial terms, intellectual property, and operational responsibilities between parties (Correct answer)
- To replace the protocol as the governing document
- To outline only the payment schedule for research services
- To specify the statistical analysis plan for the study
Correct answer: To define publication rights, financial terms, intellectual property, and operational responsibilities between parties
A CTA is a legal contract that governs the business and operational relationship between the sponsor and the institution, covering IP, finances, and responsibilities.
Question 6: During a study team meeting, a research nurse reports that several participants have expressed confusion about the study procedures. What should the PI do first?
- Retrain the nurse on how to explain the procedures
- Assess whether the consent form and participant materials need revision for clarity (Correct answer)
- Dismiss the concern if no protocol deviations have occurred
- Instruct staff to spend more time with each participant at visits
Correct answer: Assess whether the consent form and participant materials need revision for clarity
Participant confusion signals a potential informed consent issue that requires evaluation of consent materials and participant education tools.
Question 7: A PI receives a complaint from a participant alleging coercive recruitment practices by a study coordinator. What is the appropriate response?
- Investigate the complaint internally, document findings, and report to the IRB as required (Correct answer)
- Terminate the coordinator's employment immediately pending investigation
- Dismiss the complaint if no other participants reported similar issues
- Notify the sponsor but not the IRB, as it is an internal personnel matter
Correct answer: Investigate the complaint internally, document findings, and report to the IRB as required
Allegations of coercion must be investigated, documented, and reported to the IRB, which has oversight over the consent process.
CPI Communication & Stakeholder Relations 3
A regulatory authority conducts an unannounced site inspection.
What is the PI's immediate priority?