Page 244 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q013
SOP Title: Guideline for Revising SOAs Impacted by Modifications
5. SPECIFIC PROCEDURE
• A ‘CMC – Modification Submitted’ e-mail notification is received in the mailbox.
• An assigned QS team member will evaluate the type of modification.
• Only MOD submissions involving updates to the protocol will be logged and tracked.
A. MOD application will be carefully reviewed and detailed notes, including addition of new services, new visits, or modifications to the visit schema, will be recorded by the assigned QS. Findings are expected to be completed in three business days.
B. Assigned QS team member will meet with the Research Administration (RA) Senior Director and review the MOD in detail to determine whether the proposed changes to the protocol will impact services at Children’s Health and whether new charges will need to be added to the SOA.
C. Following confirmation with RA Senior Director, QS team member will engage members of the research team (PI/PRC/PAC) that the proposed changes to the protocol will impact the SOA and may require an update to the CTCA.
D. QS will track progress of MOD submission and will inform Senior Director, RA Finance Manager and members of the Finance team following the approval of the MOD by the IRB.
E. QS will update members of RA Finance of this update to the study and its potential impact on the SOA and REVEAL.
F. Depending on the PIs department, it is the responsibility of the department’s grants and contracts team to initiate a modified SOA and submit it to RA for review. Once received, the modified SOA will be assigned to the QS finance team member to review and confirm that all new services are identified and properly documented on the modified SOA. This will include meetings with the Senior Director for verification that new services are identified and documented as well as input from members of the RA finance team for pricing of new services.
G. In the interim, a member of the finance team will reach out to the PI/PRC to verify the new services being performed while the modified SOA is in process. The purpose of this step is to ensure that patients and/or their payers are not billed in error by the institution.
H. Once the modified SOA is fully reviewed by CMC RA team, it will be routed by to the UTSW counterpart for final review and DocuSign. The updated fully executed SOA will replace the existing one and updates to REVEAL will be made accordingly.
SOP No. 12, 12-20-2018