Study2 SMC 2015 – Flashcards
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The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions?
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European Union, Japan and United States
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What other organizations are represented in the ICH Steering Committee?
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Australia, Canada, the Nordic countries and the World Health Organization (WHO)
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What ethical standards are the ICH Documents based on?
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Declaration of Helsinki
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What is the status of ICH in U.S.?
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It is a guideline
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A primary purpose of the ICH is to:
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Minimize the need for redundant research.
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The ICH GCP Guidelines:
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Set standards for the design, conduct, monitoring and reporting of clinical research.
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Which of the following are the three principles discussed in the Belmont Report?
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Respect for Persons, Beneficence, Justice.
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Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
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Determining that the study has maximized benefits and minimized risks.
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Which of the following best describes the principle of informed consent as described in the Belmont Report?
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Information, comprehension, voluntariness.
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What important ethical principles were the result of experimentation in concentration camps during World War II
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Nuremberg Code
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What pivotal study triggered the development of US research regulation and the Belmont Report?
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Syphilis Study at Tuskegee
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What organization developed the Declaration of Helsinki
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World Medical Association
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Who is the Declaration of Helsinki mainly meant to address?
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Physicians
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Who published a manuscript in the New England Journal of Medicine presenting evidence that unethical studies were wide spread and represented a systemic problem in medical research?
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Henry Beecher
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What does part A of the Belmont Report cover?
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Boundaries between practice and research
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Ensuring that a subject is treated as an autonomous agent is a reflection of what ethical principle?
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Respect for persons
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Selecting subjects based on reasons directly related to the problem being studied is a reflection of what ethical principal?
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Justice
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What is the minimum number of IRB members required by regulation?
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5
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According to DHHS and FDA regulations, who can conduct expedited review?
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The IRB chair, other IRB members designated by the chair, or a sub-committee of the IRB
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The IRB may invite non-members with expertise in special areas for assistance. True or False
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True
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In accordance with DHHS and FDA regulatory requirements, expedited review can be conducted on:
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A study involving no more than minimal risk and is on the DHHS and FDA specified list of categories eligible for expedited review
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Private information must be individually identifiable in order to constitute research involving human subjects. True or False
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True
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The following statement supports which one of the criteria for IRB approval of research? Blood for research lab tests will be drawn at the same time as for clinically indicated labs so that an extra needle stick is not necessary.
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Risks to subjects are minimized
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According to regulation an IRB must ensure that it does not consist of entirely one _____
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Gender and Profession
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A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge is the regulatory definition of
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Research
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Research may receive approval if there is a minority of the IRB members present at the convened meeting. True/False
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False
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Subpart B of 45 CFR 46 concerns the protection of
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Pregnant women
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Subpart C of 45 CFR 46 concerns the protection of
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Prisoners
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Which 45 CFR 46 subpart did the FDA adopt?
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B,C,D
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Subpart D of 45 CFR 46 concerns the protection of
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Children
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OHRP is an oversight body primarily concerned with: A. Adherence to FDA regulations B. Compliance with ICH Guidelines C. Approval of new drugs D. Protection of human research subjects
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D. Protection of human research subjects
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What type of research is covered by the regulations at 21 CFR 50?
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FDA regulated research
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This regulation is also referred to as the Common Rule
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45 CFR 46 Subpart A
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When a clinician uses a test article for Emergency Use is prior IRB approval required? Yes/No
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B. No
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Any experiment that involves a test article and one or more human subjects is the regulatory definition of
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A Clinical Investigation
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What member of the IRB must be present for an IRB meeting to be conducted?
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The non-scientist
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Informed consent may be completely waived in emergency medicine research when:
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The research involves an investigational intervention under FDA special regulation at 21 CFR 50.24
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Which one of the following federal agencies has issued guidance stating that research subjects should be informed that the agency may review the subjects' individual medical records?
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The Food and Drug Administration
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According to regulations, "exculpatory language":
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Includes any language through which the subject is made to waive, or appear to waive, any of the subject's legal rights
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What situation is most likely to qualify for waiver of informed consent?
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Research that involves a retrospective review of data from the medical record to evaluate outcome following hip replacement surgery
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According to ICH, an impartial witness should be present during the entire informed consent discussion when subjects or legally authorized representatives are unable to read True/ False
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True
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In terms of explaining the probability of assignment to trial arms in consent forms, which is true? A. Only the FDA recommends it B. Both FDA and ICH require it C. ICH notes that it should be included
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C. ICH notes that it should be included
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If a short-form consent is used to obtain consent from a subject who does not speak English, what form would the witness sign?
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The English version of the long consent form The translated version of the short form
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In what situation may an IRB waive the requirement to obtain consent for FDA regulated research?
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If the study is approved under 21 CFR 50.24
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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?
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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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Which of the following statements is an example of exculpatory language? A. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out. B. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. C. In the event of any injury related to this research, you will be given medical treatment. D. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for.
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B. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
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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 Adescribes 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 what circumstance does the FDA allow a waiver of documentation of consent prior to participation in a research study?
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The study is minimal risk.
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GS-US-312-0118: A Phase ?, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Obinutuzumab Compared to Chlorambucil in Combination with Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia - This is most likely what phase?
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Phase 3
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RU241306I, Randomized Double-Blind Phase ? Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers - This is most likely what phase?
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Phase 2
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GA29145: "An Open-Label Extension and Safety Monitoring Study of Patients with Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase ? Protocol GA29144" - This is most likely what phase?
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Phase 3
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R1979-HM-1333: An Open-Label, Multi-Center Phase ? Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Cd20+ B-Cell Malignancies Previously Treated With - This is most likely what phase?
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Phase 1
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11956, Phase ? dose-escalating, open-label, non-placebo controlled study of BAY 43-9006 (sorafenib) in combination with carboplatin, paclitaxel and bevacizumab in previously untreated patients with Stage IIIB (with malignant pleural effusions) or Stage IV non-small cell lung cancer (NSCLC) - This is most likely what phase?
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Phase 1
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Investigational new drugs do not require any special labeling. True/ False
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False
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Can a sponsor test market an investigational new drug? A. Yes B. No
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B. No
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Can a sponsor charge for investigational drugs under an IND? A. No B. Yes with written authorization from the FDA C. Yes but only for the direct cost of making the drug D. Yes when B and C are true
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D. Yes when B and C are true
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What is the difference between Emergency Use of a test article and Non-emergent expanded access (formerly called compassionate use)?
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Whether or not there is time to obtain IRB review prior to administration
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A sponsor can include that an investigational new drug is safe and effective on the labeling. True/False
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False
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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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Use of a marketed drug off label in the course of medical practice is considered a clinical investigation. True/False
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False
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Whenever a sponsor intends to conduct a study that is not covered by a protocol already contained in the IND the sponsor must submit a protocol amendment to the FDA. True/False
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True
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When a new investigator is added to carry out a previously submitted protocol is the sponsor required to submit a protocol amendment to the FDA? A. Yes B. No
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A. Yes
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An investigational new drug includes:
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New drugs New biological drugs Biological products used in vitro for diagnostic purposes
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An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug as part of clinical care, using the labeled marketed dose, for the patient. Which of the following would be the most appropriate course of action?
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Treat the patient with the drug based on physician's best medical judgment
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An investigator proposes to study a marketed drug sold to treat high blood pressure. The drug is approved for adults, but the investigator proposes to study the drug with individuals over age 12. The manufacturer is supplying the drug and hopes that the information from the research can be used to change the labeling for use of the drug in children. Which of the following is the investigator's most appropriate course of action?
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Submit an IND application to the FDA and obtain IRB approval.
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When does an IND go into effect?
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30 days after the FDA receives the IND unless the FDA notifies the sponsor of a clinical hold
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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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Use of a marketed drug off label in the course of medical practice is considered a clinical investigation. True/False
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False
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Investigational new drugs include biological products. True/False
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True
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A sponsor holds an IND for an ongoing clinical investigation. The sponsor now proposes to use the investigational drug in an emergency research study with a waiver of informed consent. The new study can be conducted under the same IND. True/False
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False
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The Investigational New Drug Application is
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Form FDA 1571
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Medical devices achieve their primary purposes through chemical action within or on the body of man or other animals. True/False
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False
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Devices are classified as:
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Class I, Class II, Class III
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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
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Pacemakers, implanted weight loss devices and cochlear implants are:
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Class III Devices
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_______are intended for use in the diagnosis of disease or conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.
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Medical Devices
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__________ permits a device that is not approved for marketing to be shipped lawfully for the purpose of conducting investigations.
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IDE
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Wound dressings, jaundice monitors for infants, and dental filling materials are examples of
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Non-significant Risk devices
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An implant is a device that is intended to remain in body for a period of ____ days or more.
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15
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A non-significant risk device is one that:
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Does not meet the definition for a significant risk device
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General controls for all classes of devices include:
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Register establishments and list medical devices with the FDA Manufacture in accordance with Good Manufacturing Practices Label devices according to regulations
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The FDA must make the determination that a device is non-significant risk True/False
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False
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All diagnostic devices are exempt from IDE requirements. True/False
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False
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Which devices typically require Premarket Approval ?
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Class III
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If a device is determined non-significant risk the investigator has no obligations to the FDA. True/False
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False
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Which devices typically require Premarket Notification 510(k)?
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Class II
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If an IRB disagrees with the sponsors determination that a device is non-significant risk who needs to be notified?
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FDA
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Which devices typically only require general controls?
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Class I
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A custom device not being tested for commercial distribution is exempt from IDE requirements. True/False
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True
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If changes are made to the investigational plan for a device study a _______ must be submitted to the FDA.
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Supplemental Application
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A diagnostic device is exempt from IDE requirements if:
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It is noninvasive It does not require an invasive sampling procedure It does not introduce energy into the subject It is not used as a diagnostic procedure without confirmation by an established procedure
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If an IRB disagrees with the sponsor's non-significant risk determination how many days does the sponsor have to report to the FDA?
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5
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Drug-eluting stent, a nicotine patch, surgical mesh with antibiotic coating, and prefilled syringes are examples of:
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Combination Products
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When is a 510(k) used?
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To demonstrate substantial equivalence to a legally marketed device
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A sponsor must obtain an IDE from the FDA in order to test a non-significant risk device. True/False
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False
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A medical device:
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Diagnoses, cures, lessens, treats or prevents disease Affects the function or structure of the body Does not achieve its primary intended purposes through chemical action
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Emergency use of a test article may occur prior to IRB approval, provided the use is reported to the IRB within how many working days?
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5 Days
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Who has responsibility to control the investigational devices?
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Investigator
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A medical device intended for the treatment or diagnosis of a disease that affects fewer than 4000 individuals in the US each year is:
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HUD
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When evaluating the causality of a suspected adverse reaction which of the following should be a consideration?
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Whether the event is otherwise uncommon in the population exposed to the drug.
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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 to the Sponsor according to the timetable specified in the protocol.
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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?
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Sponsor
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The sponsor must submit an IND safety report to the FDA if a suspected adverse reaction is both related to the use of the investigational agent AND:
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Is unexpected
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A double-blinded trial for a new indication is conducted under an IND comparing 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 to the Sponsor for:
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Both of the subjects
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During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 has an unexpected stroke that requires hospitalization. On Day 15, subject 415 complains of nausea, vomiting, and headache relieved by aspirin. On Day 21, subject 20 has brief dizzy spells upon trying to stand. An IND Safety Report is most likely filed by the sponsor with the FDA for the observations associated with
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Subject 603 only
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Subject 311 has had elevated white blood cell (WBC) counts for the past 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:
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Report the elevated WBC to the sponsor as an unexpected adverse effect
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When does an IND Safety Report have to be reported to the FDA within 15 calendar days?
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When the event is serious, unexpected and thought to be caused by the study agent
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An Adverse Reaction is:
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Any adverse event caused by a drug
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The primary document used in determining whether an event is expected is:
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The Investigator Brochure
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Who determines if an event is serious?
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Either the Investigator or the Sponsor
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An investigator must submit to the sponsor and the reviewing IRB a report of any unanticipated adverse device effect no later than:
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10 working days
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A Serious Adverse Event or Reaction is any untoward medical occurrence at any dose that:
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Results in death is life threatening requires inpatient hospitalization or A prolongation of existing hospitalization results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
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A serious, unexpected Adverse Drug Reaction must be submitted to the FDA within:
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15 calendar days
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An adverse event for which there is a reasonable possibility that the drug caused the event is
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Suspected Adverse Reaction
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Who determines if an adverse event or suspected adverse reaction is unexpected?
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The Sponsor
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Who determines if an Adverse Reaction is caused by a drug?
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The Sponsor
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Who determines if an adverse event is life-threatening?
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the sponsor and the investigator
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What serves as a guide for defining regulatory reporting obligations?
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Seriousness
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Who does the investigator submit a report of an unexpected adverse device affect to?
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the sponsor and the reviewing IRB
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The term Life-threatening includes events in which the patient was at risk of death at the time of the event and those that may have caused death if it were more severe. True/False
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False
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Investigators are required to provide a causality assessment for each serious adverse event reported to the sponsor. True/False
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True
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If an investigator assesses an event to be positive for causality, but the sponsor does not find evidence to suggest a causal relationship between the drug and the event, is the sponsor required to report it to the FDA? Yes/No
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No
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Investigators must immediately report to the sponsor all serious adverse events, regardless of whether the investigator believes that they are drug related, including those events listed in the protocol as anticipated to occur in the study population independent of drug exposure or in the investigator brochure as predicted to occur with the drug. True/False
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True
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When is financial information submitted to the FDA?
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When a marketing application is submitted
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When reporting financial information of a clinical investigator, financial information of the spouse and each dependent child of the investigator must also be included. True/False
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True
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The party who submits a marketing application to the FDA for approval of a drug, device or biologic product is:
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The applicant
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Significant payments of other sorts (SPOOS) of this amount and duration must be reported as disclosable financial interests:
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Of $25,000 or more during the time the clinical investigator is carrying out the study and for one year following completion of the study
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Which FDA Form is used for Mandatory Reporting of Adverse Events and Product Problems?
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Form 3500A
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Disclosure: Financial Interests and Arrangements of Clinical Investigators would also be known as:
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Form 3455
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Certification: Financial Interest and arrangements of Clinical Investigators would also be known as:
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Form 3454
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The investigator's financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation is reported directly to the FDA by:
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The sponsor
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The Form FDA 3455 is completed by
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The sponsor
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The Form FDA 3500 is used for
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Voluntary reporting
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FDA Form 3500A is used for
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Mandatory reporting
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Clinical Investigators financial disclosures are submitted on
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Form FDA 3455
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The FDA requires retention of investigational drug study records for
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At least two years after the investigational drug's approval by the FDA
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According to ICH guidelines, how long must an IRB retain its records for each research project?
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3 years after completion of the trial
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According to FDA regulation, how long must an IRB retain records?
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3 years after completion of the research
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According to ICH GCP how long should investigators maintain study records?
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2 years following the last approval of a marketing application
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Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?
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Periodic site visits
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Which of the following should take place during periodic monitoring visits?
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Identification of protocol violations
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The overall goal of monitoring, audits and inspection activities is to:
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Ensure the protection of human research subjects and data integrity.
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According to ICH E6 GCP, an "Audit" is defined as:
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A systematic and independent examination of trial-related activities and documents.
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According to ICH E6 GCP, an "Inspection" is defined as:
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An official review of documents, facilities, records, and any other resources related to a clinical trial.
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When the FDA conducts an inspection, the inspectors will:
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Review regulatory records.
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According to ICH GCP Investigators must be qualified by:
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Education Training Experience
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It is the monitor's responsibility to maintain a list of persons who have been delegated significant trial-related duties. A. True B. False
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B. False
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It is the sponsor's responsibility to ensure all persons assisting with the trial are adequately informed. True/False
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False
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Who is responsible for quality control for data handling?
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The sponsor
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If a sponsor contracts with a CRO who is responsible for the quality and integrity of the data?
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The sponsor
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According to ICH GCP when should sponsors supply investigators with product?
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After IRB approval documentation is obtained
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The purpose of trial monitoring is:
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Verify the rights and well-being of human subjects are protected Verify the reported trial data are accurate, complete, and verifiable from source documents Verify the conduct of the trial is in compliance with approved protocol, GCP, and regulation
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Whose responsibility is it to verify that investigational product is stored, administered and disposed of properly?
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The monitor
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If serious or persistent noncompliance is found by a sponsor, they should:
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Terminate the investigators participation in the trial Notify regulatory authorities promptly
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This study visit is conducted to determine if the investigator and clinical site have the capability to consent the study:
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Pre-Study Visit
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The study team receives protocol training at what study visit?
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Initiation Visit
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The feasibility of recruiting potential participants is discussed at what study visit?
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Pre-Study Visit
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Plans for record retention are most likely to be discussed at what study visit?
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Close-Out Visit
