Good Clinical Practice (GCP) well answered

Good Clinical Practice (GCP) Which of the following are the three principles included in the Belmont Report? - correct answer 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? - correct answer 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? - correct answer Information, comprehension, voluntariness Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor: - correct answer The sponsor In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: - correct answer Conduct or supervise the investigation personally Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: - correct answer FDA The Investigator must report adverse events to the: - correct answer Sponsor When must the investigator update the IRB about the progress of a trial? - correct answer During the conduct of the study and at termination Which of the following is an investigator's commitment to the sponsor? - correct answer Submit a new Form FDA 1572 to sponsor as needed 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 for the