CRA

?

1. What is the definition of a CRO according to the FDA?

  • Clinical research company, which hires employees on contract
  • Legal entity, which assumes one or more obligations of sponsor
  • Pharmaceutical company that outsources clinical trials to smaller companies
  • FDA doesn't have any definition
1 of 20

Other questions in this quiz

2. What does REC mean?

  • Research Ethical Considerations
  • Research Ethics Committee
  • Research Ethical Criteria
  • Research Ethics Constraints

3. How long should Sponsor-specific trial related essential document be retained?

  • 2 years after marketing approval or trial discontinuation
  • 8 years after marketing approval or trial discontinuation
  • 5 years after marketing approval or trial discontinuation
  • 20 years after marketing approval or trial discontinuation

4. What is a surrogate endpoint?

  • A subjective endpoint
  • A measurement, related to the outcome and used in place of another, which is more difficult to assess
  • A measurement, derived from a combination of assessments
  • A point at which the trial could be stopped for safety reasons

5. Who is responsible for the IND Safety Reports?

  • The Sponsor
  • The Investigator, who worked with the IND
  • The FDA
  • The IRB
View more questions

Comments

No comments have yet been made

Similar Human Biology resources:

See all Human Biology resources »See all ICH resources »