CRP Communication & Documentation 3 — Questions and Answers
Question 1: When presenting research findings to a non-scientific stakeholder audience, which communication strategy is most effective?
- Use technical jargon to demonstrate expertise
- Translate statistical results into plain-language takeaways tied to stakeholder interests (Correct answer)
- Present only p-values and confidence intervals
- Omit limitations to maintain audience confidence
Correct 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.
Question 2: Which principle governs authorship credit on a published research article according to ICMJE guidelines?
- Anyone who contributed funding should be listed as an author
- Authorship requires substantial contributions to conception, drafting, and approval of the final work (Correct answer)
- Lab technicians are automatically listed as co-authors
- Only the principal investigator may be listed as author
Correct 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.
Question 3: A sponsor requests a deviation report after a study coordinator administered a dose outside the protocol window. What should the report include?
- Only the date the deviation occurred
- Description of the deviation, its cause, impact on subject safety and data integrity, and corrective actions taken (Correct answer)
- A request to remove the subject from analysis
- The coordinator's personnel file
Correct 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.
Question 4: What is the primary purpose of maintaining a delegation of authority log in a clinical study?
- To track the study budget expenditures
- To document which study tasks each qualified team member is authorized to perform (Correct answer)
- To record protocol amendments
- To list participant contact information
Correct 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.
Question 5: Which format is most appropriate for reporting a single case study finding in a peer-reviewed journal?
- Randomized controlled trial CONSORT checklist
- Case report structured with patient history, clinical findings, intervention, and outcome (Correct answer)
- Meta-analysis forest plot
- Survey instrument with Likert scales
Correct 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.
Question 6: In data documentation, 'contemporaneous' means the record should be made:
- At the end of the study
- At the time the observation or action occurs (Correct answer)
- Within one week of the observation
- By a second team member who reviews primary notes
Correct 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.
Question 7: A research team sends a newsletter update to enrolled study participants. Under HIPAA, what must this communication ensure?
- The newsletter is printed on study letterhead only
- No protected health information (PHI) is disclosed without appropriate authorization (Correct answer)
- Participants must opt in to receive every newsletter individually
- The newsletter must be reviewed by the FDA
Correct 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.
CRP Communication & Documentation 3
When presenting research findings to a non-scientific stakeholder audience, which communication strategy is most effective?