Across
- 6. A document that explains the risks involved in study participation
- 7. Criteria a person must meet to enter a study
- 9. Degree to which study results are true believable and free of bias
- 10. An inactive substance made to look like the experimental product
- 12. The government agency who approves experimental vaccines
- 15. An organization who oversees all study sites in trial
- 16. Repeatability or consistency
- 18. A systematic approach to finding answers to questions
- 19. A written study plan that outlines the requirements of a study
Down
- 1. A serious negative change or medical occurrence that might result in hospitalization
- 2. A _________ drug or vaccine that is being evaluated in a clinical trial
- 3. Refers to the use of a vaccine in treating a particular disease
- 4. The director of a trial at a research site (usually a doctor)
- 5. Phase of study testing vaccine in healthy volunteers
- 8. A procedure (blood test) used to generate data for a trial
- 11. A negative occurrence during a study
- 13. A large phase study comparing the vaccine to a comparator to collect safety and efficacy data
- 14. Neither the MD or pt knows what is being administered
- 15. An individual enrolled in a clinical study
- 17. An ethics committee who reviews and approves research studies