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8.6 Study Hold, Suspension, and Termination
Last Revised: 1/20/2023 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Study Holds, Suspension, and Termination 1.0 Purpose The purpose of this policy is to describe the process for study holds, study ...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure prompt reporting of incidents to Institutional Officials, Federal Agencies (including OHRP and FDA) and other Common Rule Departments and Age...
Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Program 1.2 Authority Granted by the Organization 1.3 UNMC Serving as Central IRB 1.4 UNMC Ceding Review to an External Central IRB 1.5 Requirements for Research Conduct...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
Last Revised: 1/23/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Expanded Access to Investigational Drugs and Devices 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the...