References
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6.2 Research Involving Investigational and Marketed Devices
HRPP Policies and Procedures
Section 6: FDA Regulated Research/Drugs...
Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
Adverse Event Reporting
Institutional Review Board (IRB) Guidebook
Procedures
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
1.26 PI Qualifications and Responsibilities
HRPP Policies and Procedures
Section 1: General Human Research Prote...
Last Revised: 6/11/2025 1.0 Purpose The purpose of this policy is to describe the qualifications ...