Other questions in this quiz

2. The monitor is required to inspect Case Report Forms for legibility, accuracy and completeness.

  • True
  • False

3. If all information for a complete report on a fatal SUSAR is not available within 7 days, what is the deadline for a follow-up report?

  • Another 7 days
  • Another 8 days
  • There is no specific deadline
  • Another 15 days

4. Which studies are traditionally called FIH (First In Humans)?

  • Pre-clinical studies
  • Phase I studies
  • Phase II studies
  • Phase III studies

5. What must the Investigator provide to IRB at the end of the study?

  • All of the above
  • A summary of the trial outcome
  • A copy of the Final Study Report
  • A list of the enrolled patients

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