Phase I Research

Provides an introduction to phase I research and the protection of phase I research subjects.

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About this Course


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.

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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 a base subscription
Independent Learner Price: $29 per person

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Course Content


Phase I Research: Understanding Phase I Research

Defines phase I research as it relates to non-clinical and other phases of research. Identifies routine study designs used to develop the initial safety profile and achieve study objectives in phase I research. Reviews the importance of phase I research on drug development.

Recommended Use: Required
ID (Language): 16873 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research

Phase I Research: Protecting Phase I Subjects

Reviews U.S. Food and Drug Administration (FDA) requirements for initiation of phase I research studies following non-clinical studies. Describes IRB considerations for review of phase I research. Identifies ways in which researchers and staff involved in phase I research can apply the necessary safeguards to protect subjects including selecting a safe starting dose, safeguards for standard dosing regimens, selecting appropriate subjects, facility safeguards, and the role of informed consent.

Recommended Use: Required
ID (Language): 16874 (English)
Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research