Page 178 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-102 SOP Title: Finance & Regulatory Modifications
4.1.2
Modifications to Research Regulatory Documents & Approvals
4.1.2.1 Submit a modification to the IRB; importantly, if the new protocol will change the data that are shared consider requesting a modification to a DUA, DTA, MTA, or BAA in addition to any partial waivers or authorizations.
4.1.2.2 Update study logs, regulatory binder with the modification and new approvals, complete and document training of all study personnel and ancillary support, submit a modification for lab approval and Investigational Drug Services (following SOP R-Reg-003 and R-Reg-004 respectively), update source documents and lab requisition sheets, and follow the procedures for reconsent as it is applicable.
4.1.2.3 For studies using a central IRB, please follow the guidance provided on the UTSW HRPP Processes for Reliance Studies here, and contact Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378 with any questions.
SPECIFIC PROCEDURE
Modifications to Research Finances
5.1.1.1 Submit a request to the appropriate UTSW contracts mailbox.
5.1.1.2 SOA Process: The SOA is executed by the assigned UTSW contracts person, and supported by the CRC/A, the RA quality team, RA finance, and RA leadership.
5.
5.1.1
5.1.1.2.1
5.1.1.2.2
5.1.1.2.3
5.1.1.2.4
5.1.1.2.5
The CRC/A will work with their team lead to complete a CTS timesheet if necessary. They will schedule a meeting with the RA director to review and modify. Upon director’s approval, the CTS will be sent to appropriate UTSW contracts representative by the director only.
Upon receipt of the CTCA and SOA request sent from the UTSW contracts representative, the appointed Quality Specialist, Jayni George Jayni.George@Chidlrens.comwill complete a draft of the SOA.
The RA appointed Quality Specialist, Jayni George, will review and resolve all discrepancies collaboratively with the CRC/A quality specialists and UTSW contracts point person. A review will be completed with the RA Senior Director and routed to research finance for pricing upon approval.
The RA Finance Manager and RA leadership will review the SOA and provide approval of the SOA to routed for signatures by the respective UTSW Contracts representative.
The UTSW contracts personnel will route the SOA for signatures first to the PI and finally the RA Vice President will execute the SOA.
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