Roles and responsibilities -- Roles and responsibilities of the study staff, research institution and research sponsor -- The drug development process -- Roles and responsibilities of the institutional review board/independent ethics committee -- Regulations and good clinical practice guideline -- Ethical conduct in clinical research -- The informed consent process -- History behind human subject protection -- Study preparation -- Study initiation -- Conducting the research : volunteer recruitment, retention and compliance -- Conducting the study : managing monitor visits -- Adverse events and safety monitoring -- Study closure -- Managing a site audit/inspection.
