Good Clinical Practice (GCP) Questions And Answers With Verified Solutions

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? - 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 A 510(k) Premarket Notification is submitted: - When the new device to be marketed is substantially similar (equivalent) to one already on the market 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 lifethreatening 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: - Both of the subjects. A primary purpose of the ICH is to: - Minimize the need for redundant research A subject 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? - 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? - Principal Investigator According to ICH E6 GCP, an "Audit" is defined as: - A systematic and independent examination of trial-related activities and documents.According to ICH E6 GCP, an inspection is defined as: - An official review of documents, facilities, records, and any other resources related to a clinical trial. Accurate reporting of adverse events is most important for: - Ensuring subject safety. 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? - Phase III An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following? - An investigator's agreement 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 from the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator: - The investigator and another physician who is not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later. At which study visits can the site expect the sponsor to review subjects' signed informed consent forms? - Periodic and termination site visits Development of most new drugs from discovery to marketing approval usually takes: - 9 years or more During the course of administration of an investigational drug, the following events occur: 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: - Subject 603 only Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the: - SponsorFor a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? - Preclinical data Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: - FDA. ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guidelines, they must: - 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: - The sponsor