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Clinical trials

Horizontales
Shots
permission granted in the knowledge of the possible consequences
involves the administration of an investigational product
acknowledges the dignity and autonomy of individuals
small groups of people receive the trial vaccine
Phase ____ :the vaccine is given to thousands of people and tested for efficacy and safety
research studies performed in people
Verticales
vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended
medical research involving people
Ethical Principles and Guidelines for the Protection of Human Subject
To do no harm
Phase 4 used for ___ term effects
treat subjects fairly
Clinical studies final review step