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Adverse Event Reporting
Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...
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...
8.6 Study Hold, Suspension, and Termination
Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for stu...
8.5 Noncompliance by the IRB or Other Components of the HRPP
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for revi...
8.4 Review of Noncompliance by the PI, Study Team, and/or Subjects
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for revi...
7.1 Banking Human Biological Material
Last Revised: 10/7/2025 HRPP Policy 7.1 has been merged with HRPP policy 7.2 Please refer to HRPP...
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...
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...
5.3 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...
4.5 Local 407 Panel Review of Pediatric Research
Last revised: 2/19/2018 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...
3.2 Data and Safety Monitoring
Last Revised 12/22/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.33 Posting of Clinical Trial Consent Forms
Last Revised: 9/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the O...
1.29 ClinicalTrials.gov Reporting
Last Revised: 3/20/2023 1.0. Purpose The purpose of this policy is to describe the requirements ...
Frequently Asked Questions (FAQ)
Below are a number of commonly asked questions. The questions will either provide an answer or wi...
ClinicalTrials.gov (CT.gov)
Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...
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 r...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 8/6/2025 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: 10/2/2024 1.0 Purpose The purpose of this policy is to describe the process for rep...
7.3 Data Registries
Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...