Communication & Stakeholder Relations Flashcards

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

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.

A PI is co-authoring a publication with a sponsor employee. Which communication practice is essential?

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.

Which approach best manages community stakeholder expectations when conducting research in a vulnerable population?

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.

A participant contacts the PI directly after receiving their test results, seeking medical advice beyond the study scope. How should the PI respond?

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.

What is the primary purpose of a clinical trial agreement (CTA) in sponsor-PI communications?

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.

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?

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.

A PI receives a complaint from a participant alleging coercive recruitment practices by a study coordinator. What is the appropriate response?

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.