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CITI TRAINING Exam Review 2025 Questions
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Which best matches the NIH definition of a clinical trial? A research study in which one or more humans subjects are assigned to evaluate the effects of those interventions involving health-related biomedical and behavioral outcomes. Adjudication of research participant's bills allows which department to direct charges to the correct payer? Clinical Trials Billing Department (CTBD) To facilitate Pre-award submissions and their approval, the study team should submit to the Institutional Review Board (IRB) at the same time they are submitting to OCR, and OSP/OTT. True Non-licensed clinicians can dispense and educate subjects about their medication. False
Which system provides the status of a clinical trial agreement (CTA)? Emory Contracts Tracking System (eCTS) If the FDA schedules an appointment to inspect your studies, which department at Emory should you contact first in preparation for the FDA visit? Office of Compliance How often should research administrators or PIs initiate a routine "New Proposal Financial Interest in Research Report" for each project in eCOI? Annually The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage Analysis (MCA) are used interchangeably. At Emory, the purpose of the PRA is to assist with research billing compliance, which is Billing the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects involved in a research study. When patients receive a copy of an organization's privacy notice, why are they asked to sign an acknowledgment? It shows they received it.
Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines? Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section. Which author is normally responsible for sharing reprints of a publication with readers? The corresponding author. Which of the following is true regarding an acknowledgments section? The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship. Which of the following most accurately describes the practice of ghost authorship? It is a situation where the individual who wrote the manuscript is not listed as an author. Which of the following statements is true regarding authorship practices?
Different disciplines have different practices about who should be included as an author. What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions? It allows institutions to have control over the intellectual property from federally- funded research. The most important factor determining whether a research collaboration will be successful is: Whether there is ongoing communication about goals and responsibilities. A research collaboration can be enhanced by: Discussing intellectual property issues while the collaboration is forming. What is the most appropriate process for determining which journal a collaborative research team should submit their work to? The research team should discuss the issue early on and while the project is ongoing. Data ownership is typically determined by:
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)? To determine compliance with regulatory requirements, including those relating to protecting research subjects. Which of the following is true regarding data acquisition? Data acquisition should follow a detailed collection plan that is set in advance. In the research context, the term validity most commonly refers to: Whether operationalized terms actually measure what they purport to measure. Which of the following is true regarding the reporting of research results? Clear specification of the methods and procedures used is essential. Which of the following is true regarding data analysis? Data analysis methods should usually be specified in advance before a study begins. The best time to prepare for an FDA inspection is:
When you are initiating your study The protocol, as approved by the IRB, must be followed even in those cases in which the specified activity would not be performed in a treatment situation except when it is necessary to eliminate an immediate hazard to human subjects. True When a subject signs a consent document, a note in the research record should include: All of the above Which of the following should be part of the FDA inspection process? All of the above Failure to adhere to the protocol and the signed investigator statement/agreement is one of the most common inspection and audit findings. True When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Is there a power differential between researchers and subjects?
Realization that ethical abuses are not limited to the Nazi regime The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners may be used to conduct research that only benefits the larger society The National Research Act of 1974 Established the National Commission. Which of the following is included in the Nuremberg Code: Voluntary consent Issued in 1974, 45 CFR 46 raised to regulatory status US Public Health Service Policy A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.
How long is an investigator required to keep consent documents, IRB correspondence, and research records? For a minimum of three years after completion of the study According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: The changes must be immediately implemented for the health and well-being of the subject. IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Occur at least annually.
The purpose of informed consent is: To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research. A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names, or other information) and subjects may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? Confidentiality of the individual subject's responses A researcher wants to invite therapists to participate in small focus groups to discuss their perceptions regarding "troubled" adolescent girls and the relationships they have with their parents. Specific clients of the therapists will not be discussed. Which of the following will be the most important issue for the researcher to consider when planning the research? Breach of confidentiality from the focus group subjects (therapists)
An example of an institutional COI is: An industry sponsor pays for the construction of a new research laboratory at the organization The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: There may be bias by the peer reviewer as to the area of research During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Disclose their potential COI and may answer questions, but recuse themselves from voting A researcher's membership on an advisory board with an organization sponsoring research can create a COI because: It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success The FDA regulations governing disclosure of individual COIs require: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
Clinical Trials Audit and Compliance Getting your proposal prepared for review and approval can be cumbersome. Which department in the Office of Research Administration assists with proposal preparation? Research Administration Services (RAS) Which of the following most accurately describes the risks associated with SBR? Less predictable, more variable, and less treatable than physical harms Which of the following is considered a SBR data collection method? Interviews A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects. Which of the following considerations was relevant to the IRB's determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers. An investigator obtains consent and HIPAA authorization from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with subject identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes: A breach of confidentiality As part of a research study, a physician plans to review medical records to explore factors related to 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient's information; however, the "key" to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true? The study is human subject research which is eligible for expedited review. A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified? Significant risk device
The medical center to replace the use of paper records with electronic records for its research. Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization. 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: Data that does not cross state lines when disclosed by the covered entity. If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. Recruiting into research ... Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.
The HIPAA "minimum necessary" standard applies... To all human subjects research that uses PHI without an authorization from the data subject. What are the main elements necessary for ensuring that costs are appropriately charged? Applying allocable, allowable, consistent, and reasonable costing policies and procedures. Which of the following most accurately describes voluntary committed cost sharing? It means that the cost share is quantified in the proposal but not required by the sponsor. Which of the following most accurately describes the main purpose of the OMB Circulars? They outline the rules for the financial management of sponsored projects. Closeout instructions on a sponsored project are most directly determined by: The terms and conditions in the agreement with the sponsor. Which of the following most accurately describes allocability?
