Question 1A 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. Report the adverse drug experience to the IRB only if there are several other occurrences. Report the adverse drug experience as part of the continuing review report. Do not report the adverse drug experience to the IRB since it is a common adverse experience.Question 2How long is an investigator required to keep consent documents, IRB correspondence, and research records? As long as the investigator is at that institution Until data analysis is complete Until the study is closed For a minimum of three years after completion of the studyQuestion 3According 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 is required for a student research project The study does not require informed consent or survey instruments. The study includes only research subjects that are healthy volunteers. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulationsQuestion 4Amendments 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. They only involve changes to the consent form. They are eligible for review using expedited procedures. The investigator keeps careful records of all changes and includes them in the final report.Question 5IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must: Include copies of all signed consent forms. Be conducted by an expedited review. Occur only when the level of risk changes. Occur at least annually.

Mandatory elements in the definition of an adverse event (AE) include which of the following?A. Untoward medical occurrence.B. Use of pharmaceutical product or a study intervention.C. Patient or clinical investigation subject involvement.D. Causal relationship with the pharmaceutical product.E. A, B, and C onlyF. All of the above.

What information should be provided to an IRB for review at the initiation of a study?

Question 1An 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 from the individual’s LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator: The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later. Use the test article without obtaining consent from the subject or the LAR then notify the IRB. Do not use the test article until either the subject or the subject's LAR can give consent. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.Question 2The 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. To document the investigator's participation in the consent process. To obtain a signature from a study subject in order to document his or her agreement to participate in research. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution.Question 3A 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? 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. 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. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. In the event of any injury you may have related to this research, you will be given medical treatment.Question 4A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on-going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? Do not tell the subject about the new drug because physicians have the right to try out new treatments with their patients. Give the subject comprehensive information about the new drug, including its side effects. 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. Tell the subject about the new drug but discourage him from switching treatments until the study is completed. Withhold this new information to avoid confusing the subject with other treatment options or alternatives.Question 5An elderly gentleman, whose wife is his legally authorized representative (LAR) since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject's wife is out of town on a business trip.Which of the following is the most appropriate action to take for the investigator? Send a copy of the informed consent via facsimile to the subject's wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back. Exclude the man from the study. The investigator can go ahead and enroll the man without a signed consent. Consult a colleague about his opinion. If the colleague agrees, enroll the man without a signed consent.

An Investigator participating in a clinical trial is responsible for protecting the rights, safety, and welfare of trial participants. Part of this responsibility is:A. Ensuring all subjects are consented appropriately and documented using the IRB approved Informed Consent form.B. Making sure that target enrollment goals are met.C. Enrolling subjects into the study who meet the exclusion criteria.D. Ensuring that the names of all subjects participating in the study are available to the general public.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is not required unless additional risks have been identified. Must be conducted by a convened IRB. Must occur within 12 months of the approval date. Is limited to review of unanticipated problems.