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Question: 3

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

  1. efficacy
  2. intent to treat
  3. per protocol
  4. safety


Answer: D

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Question: 3

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

  1. efficacy
  2. intent to treat
  3. per protocol
  4. safety


Answer: D

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Question: 2

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

  1. 21 CFR Part 11
  2. Good Clinical Practices
  3. MedDRA
  4. WHODrug


Answer: B

Question: 4

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?

  1. treatment and control group
  2. investigator and subjects
  3. statistician and sponsor
  4. sponsor and investigator


Answer: B