Research and Innovation

Research Compliance

Institutional Review Board Standard Operating Procedures


Section I: Administrative Management

IRB SOP I-001 Definitions

IRB SOP I-002 Institutional Official Membership Management and Responsibilities of the IRB

IRB SOP I-003 Standard Operating Procedures

IRB SOP I-004 Daily or Routine Tasks

IRB SOP I-005 Record Retention and Record Management

IRB SOP I-006 Activities that Require IRB Review

IRB SOP I-007 Cayuse Electronic System

 

Section II: IRB Members and Meetings

IRB SOP II-001 IRB Formation Update and Deactivation

IRB SOP II-002 IRB Membership

IRB SOP II-003 Member Review Expectations

IRB SOP II-004 IRB Convened Meeting Preparation

IRB SOP II-005 IRB Meeting Scheduling and Notification

IRB SOP II-006 IRB Meeting Attendance – Quorum Monitor - Meeting Conduct – Committee Review

IRB SOP II-007 Meeting Minutes

IRB SOP II-008 IRB Member Education

 

Section II: Principal Investigator Roles and Responsibilities

IRB SOP III-001 Principal Investigator Roles and Responsibilities

IRB SOP III-002 Pre-Review

IRB SOP III-003 Information submitted to the IRB

IRB SOP III-004 Non-Committee Review Preparation and Review Conduct

IRB SOP III-005 Approval Review and End Dates

IRB SOP III-006 Expiration of IRB Approval

IRB SOP III-007 Consultation

IRB SOP III-008 Consent Documentation

IRB SOP III-009 Participant Selection Recruitment and Payments

IRB SOP III-010 Monitoring for Study Closure

IRB SOP III-011 Management of Multi-Site Research

IRB SOP III-012 Reliance on External IRB

IRB SOP III-013 Review of International Studies

IRB SOP III-014 Non-Affiliated Investigator Submissions

IRB SOP III-015 External Site Authorization to Conduct Research

IRB SOP III-016 Terminated and Changed Status Users

IRB SOP III-017 IRB Administrative Study Closures for Non-Communication from Investigator

IRB SOP III-018 Repositories Banking of Identifiable Specimens or Data

 

IRB SOP Section IV Post-Approval Monitoring and Non-Compliance

IRB SOP IV-001 Post Approval Monitoring

IRB SOP IV-002 Post Review

IRB SOP IV-003 Reportable New Information Items

IRB SOP IV-004 New Information Process

IRB SOP IV-005 Unanticipated Problems and Adverse Event Reporting

IRB SOP IV-006 Managing Non-Compliance in Human Subject Research

IRB SOP IV-007 Investigation Suspension Termination by Institution