CITI Training HFH

29 August 2022
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28 test answers

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question
Which of the following is likely to be the level of review determined as appropriate by the IRB?
answer
Exempt as the study presents no greater than minimal risk and does not collect identifying information.
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Would this research be eligible for exemption?
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No. The investigator may be able to identify subjects based on telephone numbers and birth dates, so this should not be considered exempt.
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An investigator has proposed a multi-site study of PSA (Prostate Specific Antigen) test results among patients with prostate cancer. The research involves only review of medical records at institutions in several states. The investigator will not collect any identifying information on the subjects, only their PSA scores and ages (which will be collected in a range format so as to not have the person's specific age). The investigator may correctly conclude that:
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IRB review, or similar process, may be required since generally investigators are not able to exempt their own research.
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Decisions about compliance with HIPAA's research provisions may sometimes be made by:
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An organization's IRB, "Privacy Board", "Privacy Officer", or "Security Officer," depending on the particular issue and the requirements of the HIPAA regulations.
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Under HIPAA, a "disclosure accounting" is required:
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for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.
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If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
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An organizational IRB or Privacy Board, "Privacy Officer", or "Privacy Official," depending on the issue.
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The HIPAA "minimum necessary" standard applies
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to all human subjects research that uses PHI without an authorization from the data subject.
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HIPAA includes in its definition of "research" the activities related to
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development of generalizable knowledge.
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A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:
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Data that does not cross state lines when disclosed by the covered entity.
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HIPAA's protections for health information used for research purposes
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supplement those of the Common Rule and FDA.
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Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally
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is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.
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According to the PHS federal regulations entitled "Responsibility of Applicants for Promoting Objectivity in Research" amended in 2011, the threshold for reporting significant financial interests (investigator and his/her spouse and dependents) is:
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Greater than $5,000 of ownership in any single public entity.
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The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
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$25,000
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Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
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- Salary from an outside institution in excess of $5,000. - Equity/stock interests in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
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When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?
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IND report
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Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?
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The study is not intended to be reported to FDA to support a new indication or support a labeling change.
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Who is responsible for making the initial risk determination for a device being used in a study?
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The sponsor-investigator.
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An investigator conducting a study of a medical device under an IDE is required to complete and sign
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An investigator's agreement
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A 510(k) Premarket Notification is submitted:
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When the new device to be marketed is substantially similar (equivalent) to one already on the market
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Evaluation of Unanticipated Adverse Device Events (UADEs) must be reported to the FDA by the:
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Sponsor
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Which of the following statements in a consent form is an example of exculpatory language?
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I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
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A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?
answer
Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
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An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:
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The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.
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Under which circumstance does the FDA allow verbal consent prior to participation in a research study?
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The study is minimal risk.
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When evaluating the causality of an adverse event which of the following should be a consideration?
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The timing of the event in relation to administration of the investigational agent
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Accurate reporting of adverse events is most important for
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Ensuring subject safety.
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A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should the investigator do when learning of the crash?
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Report adverse events of both a broken wrist and a mild concussion.
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A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase 1 study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event?
answer
Principal Investigator