Definitions in Part C, Division 5

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Across
  1. 2. What a person is called who volunteers for a clinical trial
  2. 3. Acronym for international guidelines
  3. 5. Globally accepted standard of clinical practice (3 words)
  4. 8. For human use to be tested in a clinical trial
  5. 10. Any noxious and unintended response to a drug at any dose (3 words)
  6. 12. Another word for a trial
  7. 13. AE not identified in nature, severity or frequency that is serious (5 words)
  8. 17. Primary contact for sponsor. Person responsible for conduct of clinical trial at a site (2 words)
  9. 18. Investigation of a drug to be used in humans (2 words)
  10. 19. How you analyze the data from a clinical trial
  11. 20. Event Noxious occurrence in health of subject administered a drug (2 words)
Down
  1. 1. Minimum number of members for a research ethics board
  2. 2. AE with causal relationship to drug that hospitalizes, causes malformation, is life threatening or may cause death (4 words)
  3. 4. Person from Health Canada who audits a clinical trial
  4. 6. Medical professional but not a physician that can run some clinical trials
  5. 7. Document describing objectives, design, methodology, statistical considerations and organization of a clinical trial
  6. 9. Individual, corporate body, institution or organization that conducts a clinical trial
  7. 11. Key document outlining all pre-clinical and clinical data known at time of clinical trial start (2 words)
  8. 14. Approves the initiation of a clinical trial and conducts periodic reviews (3 words)
  9. 15. Acronym for globally accepted standard of clinical research
  10. 16. Term used in Canada to indicate use of a drug for purpose of sale for a clinical trial