Quality Assurance Policies & Forms

QA 901 QA/QC Program for the IRB

QA 902 QA/QC Internal Audit Program

• QA 902-A Self-Evaluation Checklist for IRBs (FDA)

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Policies & Forms: 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