Good Clinical packaged Exams with Updated Questions and Answers 100% Verified

12 months - Length of certification time for US companies that receive an adequacy determination based on the Safe Harbor Principles 7 Safe Harbor Principles - Security Choice Access Notice Data transfers Enforcement Data integrity Access - Subjects must be able to access information about ...

Which of the following best describes the principle of informed consent as described in the Belmont Report? - Information, comprehension, voluntariness. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - Determining that ...

1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review. A. TRUE B. FALSE - Answer-B. FALSE 1A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event? A. 5 days B. 2 weeks C. 24 hours...

Adverse Drug Reaction (ADR) - all noxious (harmful) and unintended responses to a medicinal product Adverse Drug Reaction (ADR) Regarding marketed medicinal products - normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Ev...

A committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. - Independent Data Monitoring Committee A compilation of ...

A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? - Discuss the pros ...

Adverse drug reaction (ADR) of marketed medicinal products: - Answer-A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Applicable regulatory requirement...