Page 181 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q004
SOP Title: Performance Site Review (PSR) / Approval (PSA) Process
4.2a. Laboratory & Pathology Services – Studies that require assistance from Laboratory and 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: the PI’s name, Velos #, STU #, along with a copy of the Protocol.
4.2b. Investigational Drug Services (IDS) – Clinical projects that utilize investigational drugs will need to have their protocol reviewed by IDS prior to initiation of the study. Researchers will be directed to IDSRx@Childrens.com and the following needs to be provided: the PI’s name, Velos #, STU #, along with a copy of the Protocol/pharmacy manual (if available)
4.2c. Standard Review – Clinical projects that utilize technologies provided by the study sponsor on loan and connect to Children’s network for the transmission of data to the sponsor or third party will need to have a Standard Review assessment. Other qualifying scenarios include the following: (1) any software which the sponsor directs the local researcher to download on a Children’s issued computer (desktop/laptop/portable device); (2) Any medical device (investigational or FDA approved) that is not being used in the Children’s environment.
4.2d. Other Departments - TBD
4.3 For projects requiring a DUA, QS will direct members of the research team to inquire with UTSW Data Intelligence (CooperativeResearch@UTSouthwestern.edu) or through eAgreements. A copy of the verification e-mail will need to forwarded to the QS for their files. PSA can be issued while a DUA is in process. QS will remind the PI not to share data with external entity until the DUA has been finalized. A copy of the fully executed DUA will be requested by the QS. For projects where the PI of record is an employee at Children’s Health, QS will direct the PI to inquire with CHRA by e- mailing 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 Quality Specialist team member reviewer will initiate Children’s performance site review at the time of IRB application submission to the HRPP.
• CHRA receives email notifications in the Research Department mailbox from IRB@mednet.swmed.edu with the subject ‘Submit Study – CMC Review.’
• Assigned QS team member will begin review of the SmartForm and all submitted documents 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. 3, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 09/18/2017; 03/19/2018; 03/19/2019; 07/17/2020; 11/02/2020; 02/25/2021; 06/03/2021, 05/31/2022