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New Phase I Research Modules

Two new modules on phase I research, Understanding Phase I Research and Protecting Phase I Subjects, are now available. Organizations may add them for no additional fee (with a base subscription).

Understanding Phase I Research Overview

This module increases awareness of phase I research as it relates to regulatory requirements, Institutional Review Board (IRB) review, and safeguards for protecting human research subjects.

Protecting Phase I Subjects Overview

This module identifies ways in which researchers and staff involved in phase I research can apply the necessary safeguards to protect subjects involved in phase I research.

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These modules are intended to be taken sequentially by all principal investigators and individuals engaged or involved in the protection of human subjects in phase I research, including but not limited to: Investigators, IRB members, Institutional Officials, IRB staff, research coordinators, research administrators, students, sponsors, and CROs.

These modules also complement institution-based training programs for new researchers, staff, and IRB members (especially community members). Such an audience would include individuals that interact with subjects in early phase clinical research activities and those that impact the safeguards for this population; from the time of protocol review and subject consent to the completion of the research.

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