PKPD101 Toward The First Clinical Studies

Transitioning from basic and discovery research to clinical testing in humans requires a major shift in mindset, skillset, expertise, and qualifications. The work becomes more complex, interdependent, and team-driven. This module will help you understand who needs to be involved, when, and what they will be doing to make this transition.

Vocabulary

Act, clinical investigation, Contract Research Organization (CRO), FDA, Investigational New Drug Application (IND), Independent Ethics Committee (IEC), Investigation new drug, investigator, marketing application, Sponsor, Sponsor-Investigator, Subject