Communication & Stakeholder Relations Flashcards

Which best describes the PI's responsibility when delegating tasks to sub-investigators?

Answer: The PI retains overall responsibility and must ensure sub-investigators are properly trained and documented on the delegation log

FDA regulations require a delegation log and specify that the PI retains ultimate responsibility for the conduct of the study regardless of delegation.

A PI receives negative peer review feedback on a grant application. How should this feedback ideally be used?

Answer: Analyze reviewer comments to strengthen the resubmission and address each critique specifically

Resubmissions that systematically address reviewer critiques significantly increase the likelihood of funding success.

Which scenario represents an appropriate use of a data safety monitoring board (DSMB) communication?

Answer: The DSMB issues a recommendation to the PI to continue, modify, or stop the trial based on interim analysis

The DSMB independently reviews interim data and communicates recommendations to protect participant safety and trial integrity.

A co-investigator at a satellite site fails to report a protocol deviation within the required window. What should the PI do?

Answer: Report the deviation to the IRB and sponsor as required, and implement corrective and preventive actions at the satellite site

Late deviation reporting must still be reported with documentation of corrective actions to prevent recurrence and maintain compliance.

What is the most effective way for a PI to communicate study milestones to institutional leadership?

Answer: Provide structured progress reports covering enrollment, safety signals, publications, and budget status

Structured progress reports covering scientific, safety, and financial elements give institutional leadership the information needed for oversight and support.

A local newspaper requests an interview about a PI's ongoing clinical trial. What is the recommended approach?

Answer: Consult institutional communications and IRB guidelines before granting any interview or releasing trial information

Media communications about ongoing trials require institutional review to ensure premature disclosure does not compromise the trial or violate confidentiality.

When a protocol requires participant diaries for data collection, what communication practice best ensures data quality?

Answer: Training participants thoroughly at enrollment with written instructions and scheduling follow-up contacts to address questions

Thorough training and ongoing follow-up contact for diary users reduces missing data and improves reliability of participant-reported outcomes.