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8.2 Review of Study Related Complaints
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 5/4/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
7.2 Use of Human Biological Material in Research
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
7.1 Banking Human Biological Material
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...
6.4 Emergency Use of a Test Article
Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy is to describe the requirements fo...
6.3 Humanitarian Use Device (HUD)
Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities
Last Revised: 11/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
Last Revised: 3/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
5.5 Use of the Short Form Consent Document
Last Revised: 11/30/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.3 Use of a Remote Consent Process
Last Revised: 2/9/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
5.1 Obtaining Informed Consent From Research Subjects
Last Revised: 1/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
4.3 Research Involving Prisoners
Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy and procedure is to describe the ...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
3.15 Managing Radiographic Incidental Findings in Human Subjects Research
Last Revised: 2/28/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
3.14 Phase I and First-in-Human Studies
Last Revised: 2/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...