Citi Training GCP an d Refresher Exam Questions with Correct Answers Which of the following defines phase I research as it relates to non-clinical and other phases of research:
- Correct Answer Phase I research is the first phase of research after animal testing and helps define
future phase II and III studies.Approximately how many subjects generally participate in phase I studies? - Correct Answer 20-80 As the amount of adaptive study designs and multiple-arm protocols increases, researchers are now adding small cohorts of a diseased population to phase I studies to assess the initial safety and effectiveness in the drug's targeted population. This approach allows researchers to gather preliminary efficacy data in the diseased population. An example of this would be: - Correct Answer A first-in-human protocol testing of a new drug being developed for the treatment of diabetes, including a group of subjects with diabetes.Many phase I studies now include adaptive study designs which allow changes to the design of the trial as new information is discovered; as is often the case with phase I studies. According to the author, adaptive trial designs have many benefits, including: - Correct Answer More efficient and thorough late phase multicenter research related to dose selection, subject selection, and safety monitoring.Identify the following type of study design that is generally used in first-in-human research study: - Correct Answer Single Ascending Dose (SAD) In first-in-human research, researchers review the non-clinical data thoroughly to assess if there is sufficient information to support the initiation of human studies. The highest dose level tested in animal species that did not produce a significant increase in adverse effects compared to a control group should be identified. This is identified as the No Observed Adverse Effect Levels (NOAEL) and is: - Correct Answer Much lower than the expected therapeutic level.Many phase I studies will compensate subjects for their time and participation in the research. The FDA (1998) includes the following statement in their Information Sheet on Payment to Research Subjects: "Financial incentives are often used when health benefits to subjects are remote or non-existent." While payment to subjects is considered a recruitment incentive and not a benefit, it is common in phase I research to: - Correct Answer Include a compensation stipend. 1 / 2
The federal regulations for the informed consent process and documentation are: - Correct Answer The same for all phases of research.The following is an IRB consideration for review of phase I research: - Correct Answer Type of subjects enrolled Which of the following is a safeguard that can be used to protect healthy research subjects involved in first-in-human research? - Correct Answer Start with a single ascending dose design to allow for small increments in the dose level.The ICH E6 guideline should be followed when: - Correct Answer Generating clinical trial data that are intended to be submitted to regulatory authorities The two important goals of the ICH E6 standard are: - Correct Answer To assure that the rights, well- being, and confidentiality of trial subjects are protected; to assure that trial data are credible.ICH E6 describes standards that apply to: - Correct Answer Investigators, sponsors, and Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs).ICH topics and guidelines fall into four main categories: - Correct Answer Quality, Safety, Efficacy, Multidisciplinary A primary purpose of the ICH E6 guideline is to: - Correct Answer Minimize the need for redundant research.According to ICH E6, if a research study is prematurely terminated or suspended for any reason, the investigator should notify the IRB/IEC/REB and applicable regulatory authorities, as well as which of the following? - Correct Answer Promptly inform the research subjects of the study termination or suspension and assure appropriate therapy and follow-up for the research subjects.Delegation of study-related tasks by the qualified/principal investigator to other study team members (for example, completion of the Case Report Form [CRF]) is permitted, provided that: - Correct Answer The individual has been trained/experienced in the task and has signed the task delegation log.
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