Section 8: AEs, Unanticipated Problems and Compliance
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...
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...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.4 Review of Noncompliance Involving the PI or Study Personnel
Last Revised: 3/6/2024 1.0 Purpose The purpose of this policy is to describe the process for revi...
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...
8.6 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...
8.7 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...