/LATEST UPDATES, 2024/25/ EXAMS PREDICTION PAPER/Good Clinical Practice (GCP), Exam Review Questions and answers, rated A+

Good Clinical Practice (GCP), Exam Review Questions and answers, rated A+ Which of the following are the three principles included in the Belmont Report? - -Respect for Persons, Beneficence, Justice. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - -Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of Respect for Persons ad described in the Belmont Report - -Information, comprehension, voluntariness. Development of most new drugs from discovery to marketing approval usually takes: - -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? - -Phase III Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? - -Preclinical Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? - -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? - -Preclinical data A primary purpose of the ICH is to: - -Minimize the need for redundant research The ICH GCP Guidelines: - -Set standards for the design, conduct, monitoring and reporting of clinical research. The ICH E6 GCP describes standards that apply to: - -Investigators, sponsors, and IRBs. In the United States, following the ICH E6 GCP is: - -Voluntary for FDA-regulated drug studies. In terms of explaining the probability of assignment to trial arms in consent forms, which is true? - - 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? - -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? - -Identification of study risks to determine which may safely be omitted from continual monitoring. 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 What is the legal status of ICH in U.S.? - -It is a FDA guidance Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? - -The study is not intended to be reported to FDA to support a new indication or support a labeling change. When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? - -IND report Who is responsible for making the initial risk determination for a device being used in a study? - - The sponsor-investigato