Other questions in this quiz

2. What is FALSE about the FDA regulations?

  • FDA may change periodically the published regulations
  • They include legal requirements for clinical research
  • Sponsor may develop his own rules
  • They reflect scientifically recognized principles
  • All of the above

3. What does the letter "A" in MedDRA mean?

  • Accumulation
  • Association
  • Activities
  • Analysis

4. Which section of the protocol should contain "Medication(s) and treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial"?

  • Trial Design
  • Trial Objectives and Purpose
  • Treatment of Subjects
  • Assessment of Efficacy

5. Which section of the protocol should contain "Criteria for the termination of the trial"?

  • Statistics
  • Assessment of Safety
  • Assessment of Efficacy
  • Trial Objectives and Purpose


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