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
A PI discovers a financial conflict of interest that was not disclosed at study initiation. What is the required action?
Answer: Immediately disclose the conflict to the IRB and institution and implement a conflict management plan
Newly identified conflicts must be promptly disclosed to the IRB and institution so an updated management plan can be implemented.
Which document formalizes the division of responsibilities between a PI and a contract research organization (CRO)?
Answer: The task order or transfer of obligations document specifying which sponsor duties are transferred to the CRO
Under FDA 21 CFR 312.52, sponsors must transfer specific obligations to a CRO in writing via a formal transfer of obligations document.
A participant from a non-English-speaking background needs to provide informed consent. What is the PI's obligation?
Answer: Use a certified interpreter and provide a translated or short-form consent document meeting regulatory requirements
FDA and ICH require that consent be obtained in a language understandable to the participant, using qualified interpreters and approved translated materials.
How should a PI respond when a sponsor's clinical research associate (CRA) identifies a monitoring finding during a site visit?
Answer: Acknowledge the findings, implement corrective actions promptly, and document the responses in the monitoring log
Prompt acknowledgment and documented corrective action demonstrate a compliant site culture and help prevent escalation of monitoring findings.
A PI is presenting study results at an international conference. Which disclosure is mandatory?
Answer: All relevant financial relationships and funding sources
Conference presenters must disclose all financial conflicts and funding sources to allow the audience to assess potential bias.
What is the most appropriate communication approach when a study must be terminated early due to safety concerns?
Answer: Promptly notify participants, the IRB, the sponsor, and regulatory authorities per protocol stopping rules, and ensure participants' transition to appropriate care
Early termination requires simultaneous, timely notification to all stakeholders — participants, IRB, sponsor, and regulators — following protocol stopping procedures.
A PI wants to add a new recruiting physician to the study team mid-trial. Which step is required before the physician can enroll participants?
Answer: Obtain IRB and, if applicable, sponsor approval, complete training, and add the physician to the delegation log before any participant contact
New study personnel must be approved, trained, and documented on the delegation log prior to conducting any study-related activities.