Page 190 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q005
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process for Expedited/Exempt Studies
prior to PSA being issued. Some departments will provide a support letter including identification of services that are required to support the study.
4.2a. Laboratory / Pathology Services – Studies that require services from Laboratory or Pathology Services will need to have a Research Laboratory Support Letter on file. Researchers will be directed to LabResearchAdmin@Childrens.com and the following needs to be provided for review: the PI’s name, Velos #, STU #, along with a copy of the Protocol.
4.2b. Advanced Analytics (AA) services - AA provides researchers with EPIC reports and other data requests following site approval. The submission process is outlined in SOP 23 Data Requests. After submission, typically a member of the AA team will need to speak with the PI to determine the exact nature of the request and the time commitment needed to provide reports, etc.
4.2c. Other Departments - Standard Review of qualifying devices / technologies may be required. Other departments that will be involved with the research will require review and approval prior to PSA.
4.3 For projects releasing data / specimens outside UTSW / CMC, QS will direct members of the research team to inquire with UTSW’s Office for Technology Development at CooperativeResearch@UTSouthwestern.edu to determine if a DUA/MTA is required. PSA can be issued while a DUA/MTA is in process. QS will remind the PI not to share data / specimens with external entity until the DUA or MTA has been finalized. For projects where the PI of record is an employee at Children’s Health, QS will direct the PI to inquire with CHRA by emailing Children’s Health Research Contracts at ResearchContracts@childrens.com for DUA or MTA determination.
5. SPECIFIC PROCEDURE 5.1 Scope PSA Review Process
Timeline of Children’s Performance Site Review
• Assigned QS team member reviewer will initiate Children’s performance site review at the time of notification of IRB application submission to the UTSW HRPP or receipt of an email from Children’s leadership that an external IRB-approved project has been received for review.
• CHRA receives email notifications in the Research Department mailbox from IRB@mednet.swmed.edu with the subject ‘Submit Study – CMC Review’, or CHRA receives an email from Children’s leadership that an external IRB-approved project has been received via email for review.
• Assigned QS team member will begin review of the SmartForm and all submitted documents or the external IRB-approved documents received from Children’s leadership for verification of all required elements for Children’s performance site approval (e.g., CMC credentialing, CMC required training, ancillary services support, review of patient-facing documents, required agreements, etc).
SOP No: 03b – Date: 12/20/18 (Draft); 02/17/21; 02/25/21; 6/3/21; 6/9/21; 8/25/21; 6/03/22