Revision Unit 3

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Across
  1. 4. An inactive substance or treatment used as a control in a clinical trial
  2. 5. International body that develops guidelines for the registration and regulation of medicines
  3. 7. Chemistry, Manufacturing, and Controls; section of a drug application describing manufacturing and quality information
  4. 9. Method used in clinical trials to prevent bias by keeping participants and/or investigators unaware of treatment assignment
  5. 10. European regulatory agency responsible for the scientific evaluation and supervision of medicines
  6. 11. Guidelines governing the conduct of clinical trials to ensure participant safety, rights, and data integrity
  7. 13. STUDIES Studies conducted before clinical trials to assess the safety and efficacy of a drug
  8. 16. Organization contracted to manage clinical trials and other research services
  9. 17. EVENT Undesirable experience associated with the use of a medical product
  10. 18. Ability of a drug or treatment to produce the desired therapeutic effect
Down
  1. 1. I Initial phase of clinical trials focusing primarily on safety and dosage
  2. 2. Application submitted to the FDA for marketing approval of a new drug
  3. 3. Study of the harmful effects of substances on living organisms
  4. 6. TRIAL Research study involving human participants to evaluate a medical intervention
  5. 8. Science of detecting, assessing, understanding, and preventing adverse effects of medicines
  6. 12. Profession and activities involved in ensuring compliance with pharmaceutical regulations
  7. 14. Application submitted to the FDA to begin clinical trials of a new drug
  8. 15. CONSENT Process in which participants are informed about a clinical trial before agreeing to participate
  9. 19. U.S. agency responsible for regulating drugs, medical devices, and food
  10. 20. Institutional Review Board; committee that reviews clinical research to ensure ethical standards