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Exam contains 97 questions

Page 16 of 17
Question 91 🔥

From the Statistical Analysis Plan, patients age is calculated as an integer relative to date randomized divided by 365.25. Given the following annotated CRF:Which programming code defines the patient's age?

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Question 92 🔥

An action plan that describes what will be done in a drug study, how it will be conducted, and why each part of the study is necessary is called:

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Question 93 🔥

What is the main focus of 21 CFR Part 11?

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Question 94 🔥

What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects?

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Question 95 🔥

A patient received at least one dose of study medication prior to withdrawing from a study. Which analysis population would always include this patient?

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Question 96 🔥

A Statistical Analysis Plan describes a clinical trial as "A 12 week, double-blind, placebo-controlled, randomized, multi-center study." Double-blind refers to which groups in this study?

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