CITI TRAINING COMPLETE STUDY GUIDE WITH COMPLEE QUESTIONS AND CORRECT ANSWERS RATED A+, Exams of Advanced Education

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CITI TRAINING COMPLETE STUDY GUIDE

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CORRECT ANSWERS RATED A+

What are the three principles discussed in the Belmont Report? Correct Answer Justice, Beneficence, and Respect for Persons Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? A. Providing detailed information about the study and obtaining the subject's consent to participate. B. Insuring that the selection of subjects includes people from all segments of the population. C. Determining that the study has maximized benefits and minimized risks. D. Ensuring that confidentiality is maintained. Correct Answer C. Determining that the study has a maximization of benefits and a minimization of risks. Which of the following best describes the principle of informed consent as described in the Belmont Report? A. Voluntariness, risk/benefit assessment, selection of subjects. B. Comprehension, conflicts of interest, risk/benefit ratio. C. Risk/benefit assessment, justification of research, comprehension.

D. Information, comprehension, voluntariness. Correct Answer D. Information, Comprehension, voluntariness. OHRP is an oversight body primarily concerned with: Correct Answer Protection of human research subjects According to ICH E6, an "audit" is defined as: Correct Answer A systematic and independent examination of trial-related activities and documents. When the FDA conducts an inspection, the inspectors will: Correct Answer Review regulatory records At which study visits can the site expect the sponsor to review subjects' signed informed consent forms? Correct Answer Periodic and termination site visits Which of the following best describes when the majority of case report form (CRF) data are verified against source record information? Correct Answer Periodic site visits When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff? Correct Answer Site initiation visit

Which monitoring visit would NOT include an inventory of investigational agents? Correct Answer Prestudy site visit Which of the following should take place during periodic site visits? Correct Answer Identification of protocol violations Census data (the final report as published by the Census Bureau) is an example of: Correct Answer Public Information According to the federal regulations, which of the following studies meets the definition of research with human subjects? Correct Answer A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period. According to the federal regulations, which of the following studies meets the definition of research with human subjects? Correct Answer A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors. According to the federal regulations, which of the following studies meets the definition of research with human subjects? Correct Answer A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or: Correct Answer Identifiable private information. In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations? Correct Answer Prisoners. According to federal regulations, the expedited review process may be used when the study procedures pose: Correct Answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible. According to the federal regulations, research is eligible for exemption, if Correct Answer The research falls into one of six categories of research activity described in the regulations. Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct? Correct Answer officials of the institution may overrule an IRB approval. Continuing review of an approved and ongoing protocol Correct Answer Must occur within 12 months of the approval date.

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? Correct Answer 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? Correct Answer 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? Correct Answer 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: Correct Answer The changes must be immediately implemented for the health and well being of the subject. IRB continuing review of an approved protocol must: Correct Answer Occur at least annually. A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children.

Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: Correct Answer Experience emotional or psychological distress. What statement about risks in social and behavioral sciences research is most accurate: Correct Answer Risks are specific to time, situation, and culture. Identify the example of when situation and time are key to assessing risk of harm in a research study: Correct Answer Asking women if they have had an abortion A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by: Correct Answer Both the magnitude (or severity) and the probability (or likelihood) of harm. Risk of harm in social and behavioral sciences generally fall in three categories, which are: Correct Answer Invasion of privacy, breach of confidentiality, and study procedures A student plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, including the types of disciplinary actions that were taken (including decisions they may have personally made) and their feelings or thoughts regarding whether those actions were

appropriate. The research data collected could have an impact on the principals' careers. The student will collect identifiers. This study would be subject to which type of review? Correct Answer Convened Review Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. Correct Answer - Protecting the rights and welfare of human subjects.

• Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human subjects.
• Reviewing subject recruitment materials and strategies. A graduate student needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans to go to the local convenience stores and ask the owners what types of junk food the store normally stocks, and which are the biggest sellers. She will not collect identifiers. This study would be subject to which type of review? Correct Answer Not Human Subjects A student is conducting a research project that involves the use of a survey. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues.

The student will not collect identifiable information. This study would be subject to which type of review? Correct Answer Determination for Exemption Which of the following studies would need IRB approval? Correct Answer Studies collecting identifiable information about living individuals. Your informed consent form must describe _______. Correct Answer All foreseeable risks and discomforts. Which type of IRB review does not require an IRB approval but does require a determination by an individual designated with that task (such as an IRB member or experienced staff person)? Correct Answer Exempt Where could student researchers and/or student subjects find additional resources regarding the IRB approval process? Select all that apply. Correct Answer - Faculty Advisor/Research Mentor

• IRB Office True or False: The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research. Correct Answer True

According to Subpart D, research with children may be eligible for exemption under Category 2 when: Correct Answer The research involves the use of educational tests A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? Correct Answer Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Correct Answer Federal regulations do not require the documentation of minors' assent. According to federal regulations, "children" are defined as: Correct Answer Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)? Correct Answer Research about aptitude testing

Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? Correct Answer The Family Educational Rights and Privacy Act. Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university? Correct Answer Directory information. The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: Correct Answer Provide parents certain rights over their children's educational records. In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools: Correct Answer FERPA, PPRA, and Subpart D of the federal regulations A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee, as well as the Big State University IRB? Correct Answer Will the researchers have collaborators at the research site abroad?

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? Correct Answer If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? Correct Answer No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency? Correct Answer Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. The age of majority in international research is determined by the Correct Answer Laws, customs, and norms in the area in which the research will be conducted.

To minimize potential risks of harm, a researcher conducting an on-line survey can: Correct Answer Design the survey so that no direct or indirect identifiers are collected. Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? Correct Answer The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed. Development of most new drugs from discovery to marketing approval usually takes: Correct Answer 9 years or more Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study? Correct Answer Phase III Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? Correct Answer Preclinical

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? Correct Answer Phase I For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? Correct Answer Preclinical data A primary purpose of the ICH is to Correct Answer Minimize the need for redundant research. The ICH GCP Guidelines Correct Answer Set standards for the design, conduct, monitoring and reporting of clinical research. The ICH E6 GCP describes standards that apply to Correct Answer Investigators, sponsors, and IRBs. In the United States, following the ICH E6 guideline is Correct Answer Voluntary for FDA-regulated drug studies. The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Correct Answer Identification of study risks to determine which may safely be omitted from continual monitoring.

What is the legal status of ICH in U.S.? Correct Answer It is a FDA guidance In terms of explaining the probability of assignment to trial arms in consent forms, which is true? Correct Answer ICH notes that it should be included, but does not specify how the information should be presented. Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations? Correct Answer The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? Correct Answer Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor: Correct Answer The sponsor The investigator must report adverse events to the Correct Answer Sponsor.

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: Correct Answer Conduct or supervise the investigation personally. Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: Correct Answer FDA. When must the investigator update the IRB about the progress of a trial? Correct Answer During the conduct of the study and at termination Which of the following is an important component of drug accountability? Correct Answer Drug shipping and disposition records Who has ultimate responsibility for an investigational product? Correct Answer Investigator Investigational product dispensing or administration information for the sponsor is recorded on the: Correct Answer Case report form The packaging of investigational drugs should ideally Correct Answer Be designed to help with subject compliance

Where is information on storage requirements for the investigational product usually found? Correct Answer In the study protocol An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following? Correct Answer An investigator's agreement A 510(k) Premarket Notification is submitted: Correct Answer When the new device to be marketed is substantially similar (equivalent) to one already on the market Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the: Correct Answer Sponsor 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: Sign the consent form on behalf of the subject and use the test article. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately. Do not use the test article until either the subject or the subject's legally authorized representative can give consent.

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. Correct Answer 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. Which of the following statements in a consent form is an example of exculpatory language? Correct Answer I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. A 46-year-old man is currently enrolled in a phase III 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? Correct 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 Under which circumstance does the FDA allow verbal consent prior to participation in a research study? Correct Answer The study is minimal risk. When evaluating the causality of an adverse event, which of the following should be a consideration? Correct Answer The timing

of the event in relation to administration of the investigational agent Accurate reporting of adverse events is most important for: Correct Answer Ensuring subject safety. 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? Correct Answer Report adverse events of both a broken wrist and a mild concussion. 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 I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event? Correct Answer Principal Investigator The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and: Correct Answer (3) there is a reasonable possibility that the drug caused the event A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved

prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. The investigator would submit an SAE report for: Correct Answer Both of the subjects During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization; On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of these subject's events meets the FDA definition of "serious" and "unexpected" and would require the sponsor to file an IND Safety Report with the FDA? Correct Answer Subject 603 only Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. "Increased WBC count" is not listed in the Investigator's Brochure (IB) as an adverse event. The investigator should: Correct Answer Report the elevated WBC to the sponsor as an unexpected adverse event The overall goal of monitoring, audits, and inspection activities is to: Correct Answer Ensure the protection of human research subjects and data integrity

According to ICH E6, an inspection is defined as: Correct Answer An official review of documents, facilities, records, and any other resources related to a clinical trial. Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? Correct Answer Designing the survey so that subjects are not forced to answer one question before going to the next. Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? Correct Answer A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool? Correct Answer An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may

show: Correct Answer There may be bias by the peer reviewer as to the area of research What is the term for management controls that are built in to a research study (for example, independent data analysis)? Correct Answer Inherent controls During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: Correct Answer 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: Correct Answer It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. Correct Answer No later than the time of proposal submission A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery.

Based on HHS regulations, should the researcher report this event to the IRB? Correct Answer No, this does not need to be reported because it is unrelated to participation in the study. Researchers must report potential unanticipated problems that involve risks to others directly to the: Correct Answer Institutional Review Board (IRB) A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (in other words, the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe? Correct Answer Promptly The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are: Correct Answer Determined by the institution in its written policies and procedures According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria: Correct Answer

Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk Three principles of Belmont Report Correct Answer Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence Correct Answer MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest Correct Answer TRUE The Belmont Report Respect for Person Correct Answer Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines and delineates... Correct Answer "Practice" and "Research" The Belmont Report

The Principle of Justice Correct Answer Research benefit and burden distribution and that selection of subjects is fair. T/F The Belmont report describes the necessity to effectively manage conflicts of interest Correct Answer FALSE Students in Research The history of ethical regulations in human subjects research began with the Correct Answer Nuremberg Code Nuremberg Code Correct Answer Human subjects research guidelines and regulations Year of the Nuremberg Code Correct Answer 1949 Additional resources regarding IRB approval process Correct Answer Faculty advisor/Research Mentor IRB office Human subjects research websites What element must be included in an informed consent? Correct Answer All foreseeable risks and discomforts

Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? Correct Answer If the study qualifies for EXEMPTION Another name for the "Exempt" status Correct Answer the Common Rule stated in Title 45 Part 46 Subpart A How can faculty researchers avoid coercion of student subjects? Correct Answer Avoid using their own students in their research Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information. Correct Answer Exempt Review category 2 Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects. Correct Answer Full Board Review Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal Correct Answer Expedited review