Professional Standards & Best Practices 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 Professional Standards & Best Practices flashcards as text
A CRP professional notices that an IRB-approved protocol has drifted from the actual procedures being used. What is the required action?
Answer: Submit a protocol amendment to the IRB and pause non-urgent deviations
Protocol deviations require a formal amendment submitted to the IRB, and significant deviations may necessitate pausing procedures until approval is granted.
Which standard specifically governs the protection of personally identifiable information (PII) in federally funded research in the United States?
Answer: HIPAA Privacy Rule and the Common Rule (45 CFR 46)
HIPAA and the Common Rule (45 CFR 46) together establish federal standards for protecting PII and health information in research contexts.
What is 'certificate of confidentiality' in U.S. research, and why is it used?
Answer: A federal protection that shields research data from compelled legal disclosure
A Certificate of Confidentiality is issued by NIH and protects identifiable research data from forced disclosure in legal, administrative, or legislative proceedings.
When authorship is disputed on a multi-site research paper, what standard should be applied to determine legitimate authorship?
Answer: ICMJE criteria: substantial contribution, drafting/revision, final approval, and accountability
The ICMJE (International Committee of Medical Journal Editors) criteria are the globally accepted standard for determining legitimate authorship.
A researcher plans to use existing medical records for a retrospective study. Under the Common Rule, this is most likely classified as:
Answer: Exempt research if data are de-identified per HIPAA Safe Harbor standards
Retrospective chart reviews using de-identified data typically qualify for exemption under 45 CFR 46.104(b)(4) when HIPAA de-identification standards are met.
What does 'minimal risk' mean in the context of human subjects research regulation?
Answer: The probability and magnitude of harm is not greater than that ordinarily encountered in daily life
The regulatory definition of minimal risk compares research risks to those encountered in everyday life or routine physical or psychological examinations.
A CRP professional is designing a survey on politically sensitive topics. Which sampling approach best reduces response bias?
Answer: Stratified random sampling with anonymous response collection
Stratified random sampling combined with anonymity reduces self-selection bias and social desirability effects on sensitive topics.