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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 (# re...
Voorbeeld 3 van de 19 pagina's
In winkelwagen1. 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 (# re...
What is the goal of a Confirmatory trial? - ANSWER-to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? - ANSWER-to help provide a basis for confirmatory trials When is a composite variable useful? - ANSWER-when a single variable cannot be selected from mult...
Voorbeeld 1 van de 4 pagina's
In winkelwagenWhat is the goal of a Confirmatory trial? - ANSWER-to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? - ANSWER-to help provide a basis for confirmatory trials When is a composite variable useful? - ANSWER-when a single variable cannot be selected from mult...
c) Is not necessarily causally related to drug - ANSWER-An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to drug d) Is life threatening d) a and b - ANSWER-An adverse event is one which a) Is an unfavorable a...
Voorbeeld 3 van de 22 pagina's
In winkelwagenc) Is not necessarily causally related to drug - ANSWER-An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to drug d) Is life threatening d) a and b - ANSWER-An adverse event is one which a) Is an unfavorable a...
Adverse Drug Reaction (ADR) - ANSWER-In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse dr...
Voorbeeld 2 van de 13 pagina's
In winkelwagenAdverse Drug Reaction (ADR) - ANSWER-In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse dr...
What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER-- The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will ...
Voorbeeld 3 van de 25 pagina's
In winkelwagenWhat are expected or possible consequences of over-estimation of recruitment potential? - ANSWER-- The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will ...
ADR - ANSWER-Adverse Drug Reaction Audit - ANSWER-Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - ANSWER-Confirmation audit took place Audit Report - ANSWER-Written Evaluation - not regularly made available to ...
Voorbeeld 3 van de 22 pagina's
In winkelwagenADR - ANSWER-Adverse Drug Reaction Audit - ANSWER-Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - ANSWER-Confirmation audit took place Audit Report - ANSWER-Written Evaluation - not regularly made available to ...
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