Good Clinical Practice Guide Questions with correct Answers 2024

Good Clinical Practice Guide Questions with correct Answers 2024 The ICH E6 guideline should be followed when: A. Generating clinical trial data that are intended to be submitted to regulatory authorities B. Conducting studies under a U.S. Investigational New Drug (IND) application or Investigational Device Exemption (IDE) C. Generating quality improvement and quality assurance data D. Conducting device studies under a Canadian Investigational Testing Authorization (ITA) A. Generating clinical trial data that are intended to be submitted to regulatory authorities. ICH E6 describes standards that apply to: A. Research B. IRBs only C. Investigators, sponsors, Institutional Review Board (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs) D. Investigators only C. Investigators, sponsors, and Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) / Research Ethics Boards (REBs). ICH topics and guidelines fall into four main categories: A. Sponsor, Investigator, Statistical Analysis, Trial Management B. Quality, Safety, Efficacy, Multidisciplinary C. Sponsor, Investigator, Statistical Analysis, Research Ethics D. Quality, Security, Efficiency, Multidisciplinary B. Quality, Safety, Multidisciplinary. The two important goals of the ICH E6 standard are: A. To assure that sponsors select sites based on qualifications; to assure that data are reported on time B. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to assure that data are reported on time C. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to assure that trial data are credible D. To assure that all patients have access to a clinical trial; to assure that the trial data are credible C. To assure that the rights, well-being, and confidentiality of trial subjects are protected; to assure that trial data are credible. A primary purpose of the ICH E6 guideline is to: A. Require registration of clinical trials B. Require publication of negative trial results C. Develop mandatory worldwide regulations for drug development D. Minimize the need for redundant research D. Minimize the need for redundant research. According to ICH E6 Section 4.11.1, the investigator should notify the sponsor of serious adverse events (SAE): A. Within seven (7) days B. At the next monitoring visit C. When all the information about the SAE becomes available D. As soon as possible after the investigator is aware of the SAE D. As soon as possible after the investigator is aware of the SAE. Delegation of study-related tasks by the qualifies/principal investigator to other study team members (for example, completion of the Case Report Form [CRF]) is permitted, provided that: A. The task occurs in the screening phase of the study rather than the treatment phase B. The qualified/principal investigator is not available to carry out the task C. The individual has been trained/experienced in the task and has signed the task delegation log D. The individual has signed the task delegation log C. The individual has been trained/experienced in the task and has signed the task delegation log. Which of the following statements appears in ICH E6 Section 4.2 entitled "Adequate Resources?" A. The investigator is not obliged to demonstrate a potential for recruiting the required number of suitable research subjects withing the agrees recruitment period. B. The investigator should have sufficient time to properly conduct and complete the research study, even if this exceeds the agreed trial period C. The sponsor is responsible for ensuring that the investigator has an adequate number of qualified staff, sufficient time and adequate facilities available at all times for the duration of the study D. The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol , the investigational product(s), and their trial-related duties and functions D. The investigstor should ensure that all persons assisting the with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions. According to ICH E6 the investigator should fulfill the following criteria: -Meet all the qualification specified by the applicable regulatory requirements. -Provide evidence of qualification through a Curriculum Vitae and other documentation requested as applicable by the sponsor, the IRB/IEC/REB, regulatory authorities and institution. What is the additional requirement stated by ICH E6? A. Be qualified by education and training B. Be qualified by education C. Be qualified by training and experience D. Be qualified by education, training, and experience D. Be qualified by education, training, and experience. 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? A. Contact research subjects to ensure the immediate return of all Investigational Products B. Nothing else is required C. Promptly inform the research subjects termination or suspension and assure appropriate therapy and the follow-up for the research subjects D. Return all study supplies to the sponsor immediately C. Promptly inform the research subjects of the study termination or suspension and assure appropriate therapy and follow-up for the research subjects. Which of the following statements in a consent form is an example of language that appears to waive a subject's rights? 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. 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. C. In the event of any injury related to this research, you will be given medical treatment D. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research D. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. According to ICH E6, for a clinical trial in which there are no expected benefits subjects (that is, a non-therapeutic trial), which of the following must apply in regard to informed consent for subjects unable to give their consent personally must use a legally acceptable representative (LAR)? A. There are no particular requirements beyond the usual consent process B. There must be an impartial witness to the consent process C. The LAR must be a relative of the subject D. The objectives of the trial cannot be met by means of a trial in subjects who can give informed consent personally D. The objectives of the trial cannot be met by means of a trial in subjects who can informed consent personally.