IRB Communication and Notification Policies & Forms

CO 601 Investigative Staff

Investigator Notifications
Noncompliance

• CO 601-A Notice of IRB Approval (Initial Review, Continuing Review, Amendment)
• CO 601-B Approval Withheld Pending (Conditional Approval)
• CO 601-C Notice of Disapproved Study
• CO 601-D HIPAA Waiver
• CO 601-E Determination of Not Research
• CO 601-F Acknowledgement (Internal/External SAE, HDE Reporting, or other miscellaneous documents from sponsor and/or PI)
• CO 601-G Completion (Closure) Acknowledgement
• CO 601-H Notice of Study Termination by IRB
• CO 601-I SHS/MSU IRB Reliance Acceptance Letter (New study) - BIRB/SIRB/CRIRB
• CO 601-J OCIRB Reliance Acceptance Letter (New study)
• CO 601-K IRB Compliance Assurance
• CO 601-L Exemption Disqualification Notice
• CO 601-M Exempt Determination Letter

CO 602 Other Entities

Policies & Form: General Administration IRB Organization Functions and Operations Review of Research Review Requiring Special Consideration IRB Communication and Notification Informed Consent Responsibilities of Investigators Quality Assurance

Appendix: A Belmont Report with Acknowledgement Form B Statement Authorizing the IRB (FWA) C Studies Requiring IRB Review D List of Committees E Expedited Review Procedures F Significant Risk and Nonsignificant Risk Medical Device Studies

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