Page 99 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A010 SOP Title: RA Contracts
In the event of an amended SOA, the naming convention should be: PI last name_Velos#_PO number_AMEND.
5.4 Statement of Work (SOW) – SOW’s are received from Research Finance as fully executed documents. The RAC is responsible for filing the SOW in the appropriate PI folder using the following naming convention: PI last name_Velos#_STU#_SOW. These are not entered into the contracts system.
5.5 Reliance Agreements – UTSW HRPP is the primary IRB for CHST. For research projects where the UTSW HRPP is not the IRB of record, and CHST will be a performance site, an “Intent to Rely” agreement (e.g. Reliance Agreement) from the IRB of record may be required.
For projects where the PI is a UTSW employee, RA will receive a notification from the Reliance Program Manager at the UTSW Human Research Protections Program (HRPP) Office. If the PI is not affiliated with UTSW, the notification of the intent to rely, will be sent by the IRB of record for processing.
For projects where the PI is a CHST employee Children’s Health Research Administration will initiate the “Intent to Rely” agreement (e.g.) Reliance Agreement to the IRB of record for processing.
CHST has Master Reliance Agreements in place with some institutions. For new requests where a Master Agreement is currently in place, an email notice approving the intent to rely is sufficient. In these instances, nothing will need to be entered into the contracts system, since the master will have already been entered.
5.5.1 Receipt and Acknowledgement of Reliance Agreements
Reliance Agreements are emailed to the RA Director. The Director acknowledges the Agreement, and forwards a copy to the Quality Specialists (QS) and the RAC.
The RAC logs the agreement on tracking spreadsheet saved here: T:\CLINICAL RESEARCH\IRB Files\External IRB Tracking\_Tracker, and save a copy of the agreement in the corresponding folder located here: T:\CLINICAL RESEARCH\IRB Files\External IRB Tracking and upload a copy in the Research RedCap database.
Before performance site approval (PSA) is granted at Children’s Health, the Quality Specialists will ensure that a reliance agreement has been fully executed by all parties and accepted by the UTSW HRPP (if the PI is a UTSW employee); otherwise, Children’s will be the responsible party.
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