Good Clinical Practice Course (Medical Clinical Research)question n answers graded A+

Good Clinical Practice Course (Medical Clinical Research)A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development. - correct answer b. Minimize the need for redundant research The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical research. c. Guarantee that a submission in any ICH region will be approved for marketing. d. Replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S. - correct answer b. Set standards for the design, conduct, monitoring and reporting of clinical research. ICH E6 describes standards that apply to: a. Investigators, sponsors, and IRBs b. IRBs only c. Research sponsors only d. Investigators only - correct answer a. Investigators, sponsors, and IRBs In the United States, following the ICH E6 guideline is: a. Mandatory for investigational device studies. b. Mandatory for drug studies. c. Voluntary for FDA-regulated drug studies. d. Mandatory for studies conducted outside the United States. - correct answer c. Voluntary for FDA-regulated drug studies. Which of the following are the three principles included in the Belmont Report? a. IRB review, Federal regulations, Declaration of Helsinki. b. Informed Consent, Institutional Assurance, Researcher responsibility. c. Privacy, Confidentiality, Equitable selection of subjects. d. Respect for Persons, Beneficence, Justice. - correct answer d. 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? a. Ensuring that confidentiality is maintained. b. Determining that the study has maximized benefits and minimized risks. c. Insuring that the selection of subjects includes people from all segments of the population. d. Providing detailed information about the study and obtaining the subject's consent to participate. - correct answer b. Determining that the study has maximized benefits and minimized risks. Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? a. Voluntariness, risk/benefit assessment, selection of subjects. b. Information, comprehension, voluntariness. c. Comprehension, conflicts of interest, risk/benefit ratio. d. Risk/benefit assessment, justification of research, comprehension. - correct answer b. Information, comprehension, voluntariness. The investigator must report adverse events to the: a. FDA b. Subject c. Sponsor d. IRB only - correct answer c. Sponsor In completing Form FDA 1572, Statement of Investigator, the investigator agrees to a. Maintain records indefinitely b. Report to the FDA any adverse events that occur c. Conduct or supervise the investigation personally d. Maintain a contract with the sponsor - correct answer c. Conduct or supervise the investigation personally When must the investigator update the IRB about the progress of a trial? a. During the conduct of the study only b. During the conduct of the study and at termination c. Never d. At study termination only - correct answer b. During the conduct of the study and at termination Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the: a. FDA b. Subjects c. IRB d. Sponsor - correct answer a. FDA Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor: a. The sponsor b. The IRB c. The investigator's institution d. The investigator - correct answer a. The sponsor Under which circumstance does the FDA allow verbal consent prior to participation in a research study? a. The study is minimal risk.