Ccrc practice - Study guides, Class notes & Summaries

1. A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliance is he? A. 50% B. 64% C. 78% D. 100% 1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (# returned) = 32 (# actually taken), 8 days X 8 tablets per day =64 (# that should have been taken, 32 (# taken)/64 (# should have been taken) = .5 or 50% compliance

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1. A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliance is he? A. 50% B. 64% C. 78% D. 100% - Answer- 1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (# returned) = 32 (# actually taken), 8 days X 8 tablets per day =64 (# that should have been taken, 32 (# taken)/64 (# should have been taken) = .5 or 50% compliance 1. Twenty-six subjects were enroll...

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For a medicinal product not yet approved for marketing in a country, a company's _____ will serve as the source document in that country. - Investigator's Brochure _____ is any untoward medical occurrence that at any dose: * results in death, * is life-threatening, * requires inpatient hospitalisation or prolongation of existing hospitalisation, * results in persistent or significant disability/incapacity, or * is a congenital anomaly/birth defect. - A serious adverse event (experience)...

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CCRC Practice Questions & Answers, VERIFIED/ For a medicinal product not yet approved for marketing in a country, a company's _____ will serve as the source document in that country. - -Investigator's Brochure _____ is any untoward medical occurrence that at any dose: * results in death, * is life-threatening, * requires inpatient hospitalisation or prolongation of existing hospitalisation, * results in persistent or significant disability/incapacity, or * is a congenital anomaly/bi...

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