Definitions in Part C, Division 5

2. What a person is called who volunteers for a clinical trial
3. Acronym for international guidelines
5. Globally accepted standard of clinical practice (3 words)
8. For human use to be tested in a clinical trial
10. Any noxious and unintended response to a drug at any dose (3 words)
12. Another word for a trial
13. AE not identified in nature, severity or frequency that is serious (5 words)
17. Primary contact for sponsor. Person responsible for conduct of clinical trial at a site (2 words)
18. Investigation of a drug to be used in humans (2 words)
19. How you analyze the data from a clinical trial
20. Event Noxious occurrence in health of subject administered a drug (2 words)

1. Minimum number of members for a research ethics board
2. AE with causal relationship to drug that hospitalizes, causes malformation, is life threatening or may cause death (4 words)
4. Person from Health Canada who audits a clinical trial
6. Medical professional but not a physician that can run some clinical trials
7. Document describing objectives, design, methodology, statistical considerations and organization of a clinical trial
9. Individual, corporate body, institution or organization that conducts a clinical trial
11. Key document outlining all pre-clinical and clinical data known at time of clinical trial start (2 words)
14. Approves the initiation of a clinical trial and conducts periodic reviews (3 words)
15. Acronym for globally accepted standard of clinical research
16. Term used in Canada to indicate use of a drug for purpose of sale for a clinical trial