VCOM Institutional Policy and Procedure Manual

f. Research staff are adequately qualified and trained in the protection of human subjects. g. The PI exhibits compliance with HIPAA, ensuring privacy of subjects. h. Review of serious adverse event (SAE) reports. 9. Once the IRB Chair Person has accepted the facilitated review, the IRB Coordinator will complete the electronic Facilitated Review Acceptance Form on the CIRB website. 10. The IRB Coordinator will receive and file an email from CIRB confirming receipt. 11. The IRB will send notice to PI of acceptance and approval of facilitated review. 12. The IRB will request that the PI submit any subsequent amended documents/continuing reviews approved by CIRB. 13. CIRB will be the IRB of record for the given study and will be responsible for the review of the following: a. Continuing reviews. b. Amendments. c. Other study specific documents. d. Adverse event reports distributed by the Cooperative Group. 14. The IRB Coordinator will file and maintain the following documents per IRB protocol: a. All VCOM IRB application documents. b. Protocol. c. Applicable CIRB meeting minutes. d. CIRB Review/Continuing review application. e. CIRB Approval letter and other pertinent outcome letters. j. Copy of VCOM Notice of Review to PI as well as any other applicable correspondence. 15. The IRB will ensure the safe and appropriate performance of the research at the given institution by monitoring protocol compliance: a. The IRB will request from the PI that any serious adverse events or unanticipated problems be reported to local IRB. b. The local IRB will determine if an unexpected incident, event, or outcome meets the regulatory definition of an unanticipated problem and report to OHRP/FDA. c. The IRB will conduct a post-approval monitoring audit as per institutional policy. d. The IRB will ensure that the PI has informed CIRB of any adverse events. 16. All IRB members will refer to and abide by the terms of the VCOM IRB Confidentiality Agreement. D URATION OF P OLICY The VCOM Procedure on CIRB Facilitated Review established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean. 7. f. Local approved informed consent document(s). g. Documentation of facilitated review acceptance. h. Local reviewer notes. i. Safety reports.