CPI Communication & Stakeholder Relations 3

Question 1

A regulatory authority conducts an unannounced site inspection. What is the PI's immediate priority?

Accepted Answer

Greet the inspector, verify credentials, and notify the institution's regulatory affairs office

Answer

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?

Accepted Answer

Ensuring all authors meet authorship criteria and that sponsor involvement is disclosed

Answer

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?

Accepted Answer

Engaging community advisors early in study design and maintaining ongoing dialogue throughout the research

Answer

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?

Accepted Answer

Acknowledge the participant's concern, clarify the PI's role, and refer them to their primary care provider

Answer

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?

Accepted Answer

To define publication rights, financial terms, intellectual property, and operational responsibilities between parties

Answer

A CTA is a legal contract that governs the business and operational relationship between the sponsor and the institution, covering IP, finances, and responsibilities.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Communication & Stakeholder Relations 3