Communication & Documentation Flashcards
7 cards from real CRP 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 & Documentation flashcards as text
When presenting research findings to a non-scientific stakeholder audience, which communication strategy is most effective?
Answer: Translate statistical results into plain-language takeaways tied to stakeholder interests
Effective science communication requires translating complex findings into accessible language that connects to the audience's priorities and decision-making needs.
Which principle governs authorship credit on a published research article according to ICMJE guidelines?
Answer: Authorship requires substantial contributions to conception, drafting, and approval of the final work
ICMJE criteria require that authors make substantial intellectual contributions, participate in drafting or critically revising the work, and approve the final version.
A sponsor requests a deviation report after a study coordinator administered a dose outside the protocol window. What should the report include?
Answer: Description of the deviation, its cause, impact on subject safety and data integrity, and corrective actions taken
A complete deviation report documents what happened, why it happened, the potential effect on safety and data, and what steps were taken to prevent recurrence.
What is the primary purpose of maintaining a delegation of authority log in a clinical study?
Answer: To document which study tasks each qualified team member is authorized to perform
A delegation log ensures all study activities are performed by appropriately trained and qualified individuals, satisfying regulatory requirements for accountability.
Which format is most appropriate for reporting a single case study finding in a peer-reviewed journal?
Answer: Case report structured with patient history, clinical findings, intervention, and outcome
Case reports follow a narrative structure covering patient background, presenting features, the intervention applied, and the observed outcome.
In data documentation, 'contemporaneous' means the record should be made:
Answer: At the time the observation or action occurs
Contemporaneous documentation means recording data at the moment the event occurs, minimizing recall errors and supporting data authenticity.
A research team sends a newsletter update to enrolled study participants. Under HIPAA, what must this communication ensure?
Answer: No protected health information (PHI) is disclosed without appropriate authorization
HIPAA prohibits disclosing PHI in participant communications without proper authorization, and study newsletters must be carefully reviewed to avoid inadvertent disclosure.