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Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for study holds, study suspensions, and study termination. 2.0 Policy It is the policy of the Organization that: 2.1. The ORA has the authority to accept a study hold ...

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...

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...

Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for utilization of an investigational drug or device (test article) for treatment use. This applies to expanded access for individuals or groups ...