In the development of new drugs, there are four phases of clinical research: phase I, phase II, phase III, and phase IV. Phase I research is the first set of studies in humans to assess the safety and tolerability of new drugs. Many phase I research studies occur in healthy subjects. However, some studies, such as oncology research, include subjects with a specific condition, which may or may not be life threatening.
This course discusses phase I research as it relates to regulatory requirements, Institutional Review Board (IRB) review, and safeguards for protecting human research subjects. It supplements the foundational training provided in the Biomedical Basic course. Organizations may add the modules in this course to their basic HSR courses to provide learners with focused phase I research training.
Language Availability: English
Suggested Audiences: Contract Research Organizations (CROs), Institutional Officials, Investigators, IRB Members, IRB Staff, Research Administrators, Research Coordinators, Sponsors, Students
Organizational Subscription Price: Included in Human Subjects Research series for $1,000 per year/per site
Independent Learner Price: $29 per person