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PI/coordinator e-mails documents to VA: Connie in Research Office Connie.Steinbrunn@va

PI Team. VA . SRS. COMIRB. R&D Committee. New or Existing Applications/ Adding VA as a Site. VA Submission Process Effective 10/1/10. SRS Review/ Approval,. R&D Approval letter & VA Consent sent to COMIRB for file. *. PI/coordinator e-mails documents to VA:

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PI/coordinator e-mails documents to VA: Connie in Research Office Connie.Steinbrunn@va

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  1. PI Team VA SRS COMIRB R&D Committee New or Existing Applications/ Adding VA as a Site VA Submission Process Effective 10/1/10 SRS Review/ Approval, R&D Approval letter & VA Consent sent to COMIRB for file * PI/coordinator e-mails documents to VA: Connie in Research Office Connie.Steinbrunn@va.gov PI/coordinator also sends signed RPSS form to Angie in SRS: Angie.bartolino@va.gov PI /Coordinator Receives VA Clearance Letter; sends submission packet (including VA Clearance Letter) to COMIRB R&D Committee/ Final Approval VA Clearance Letter sent to PI/Coord COMIRB receives Paperwork and Conducts review COMIRB Approval Sent to PI without Consent document Stamp Consent And R&D Approval Letter Sent to PI and Coordinator VA pre-review Coordinated by VA Research Office VA recommends obtaining Required Research Impact Statement Signatures as soon as possible, but Required prior to R&D Approval Receipt of RIS Signatures PI can begin research Continuing Reviews, Changes, UAP’s and Closures PI can initiate changes “COMIRB” AND “VA R&D” stamped and dated R&D Approval letter & VA stamped Consent Form is sent to COMIRB for reference For changes w/consent form: COMIRB Approved VA Consent Form is stamped and sent to PI and Coordinator by the VA R&D Coordinator Changes w/o consent form revisions or UAPs require only IRB approval; do not require VA R&D approval SRS Review/ Approval * PI/coordinator e-mails documents to VA: Connie in Research Office Connie.Steinbrunn@va.gov PI/coordinator also sends signed SRS update form to Angie in SRS: Angie.bartolino@va.gov PI can continue research or close study COMIRB receives Paperwork and Conducts review VA pre-review Coordinated by VA Research Office PI /Coordinator Receives Clearance Email; Send submission to COMIRB (including VA Clearance Email) COMIRB Approval Sent to VA and PI (PI does not receive VA Consent Form) R&D Approval Letters and stamped consent form sent to PI and Coordinator VA Clearance Email sent to PI/Coord CRV’s and Closures require R&D Committee Final Approval * Version 4-September 2010 Please note: if consent or change in wording indicates that NObiosafety/radiation issues exist, full SRS consideration is NOTnecessary and no SRS-related delays will be encountered.

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