Page 150 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A017 SOP Title: Virtual Office Navigator
should submit the study closure in the eIRB and prepare the study files for long term storage. The IRB closure letter and enrollment log are provided to the RA administrative coordinator to process the study closure in long term storage in Iron Mountain. (See SOP Study Closure)
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5.1.1 5.1.2
Reliance Agreements
As part of the continued effort to grow research, our department supports various avenues to fulfil research regulatory review requirements in the educating, supporting, and shepherding of Reliance Agreements for IRB review as appropriate to the scope of our institution. Below are three primary scenarios in which a Reliance Agreement may be relevant:
PI is employed through Children’s Health and the work will occur at Children’s:
Relying Institution: Children’s Health System of Texas (CHST)
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement
Process: Request the Reliance Agreement from the Reviewing IRB to be sent to: researchcontracts@childrens.com. Upon Receipt of the Reliance Agreement, the RA director will initiate the Reliance Agreement provide updates to the stakeholders, and shepherd the process until completion.
PI is employed by UTSW and the work will occur at Children’s:
Relying Institution(s): CHST & UTSW
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement
Process: Upon Receipt of the Reliance Agreement, the RA director and team leads will initiate the Reliance Agreement with our legal team, provide updates to the stakeholders, and shepherd the process until completion. The Reliance Agreement for UTSW should be sent to: Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378.
PI is not employed by UTSW and the work will occur at UTSW:
Relying Institution: UTSW
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement
Process: Request the Reliance Agreement for UTSW from the Reviewing IRB. Engage Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378.
SPECIFIC PROCEDURE
Use the virtual Office Navigator to help you determine and follow the necessary resources and complete the respective study milestone in the establishment of your research.
Assessing the Needs for Research: FORMS
Once you have determined your research and the funding allocated to support it (contact Research_Department.Research_Department@childrens.com and Research.Finance@Childrens.com for informational support), follow the below steps on the FORMS tab.
Access the assessing Needs for Research Support Form Complete the Form