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Section 8: AEs, Unanticipated Problems and Compliance
8.1 IRB Review of Adverse Events and Adverse Device Effects
1.0 Purpose The purpose of this policy and procedure is to describe 1) the procedure to ensure p...
8.2 IRB Review of Study Related Complaints
1.0 Purpose The purpose of this policy and procedure is to describe the procedures for reporting...
8.3 IRB Review of Unanticipated Problems Involving Risk to the Subject or Others
1.0 Purpose The purpose of this policy and procedure is to describe: 1) the procedure to ensure ...
8.4 Review of Noncompliance Involving the PI and Study Personnel
1.0 Purpose The purpose of this policy and procedure is to describe the: 1) definitions and clas...
8.5 Noncompliance by the IRB or Other Components of the HRPP
1.0 Purpose The purpose of this policy and procedure is to describe the: 1) definitions and clas...
8.6 Study Hold, Suspension, and Termination
1.0 Purpose The purpose of this policy and procedure is to describe the IRB’s authority to: a) a...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure ...