Page 306 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q020
SOP Title: Adult Research Patient at Children’s Health
The examples outlined above are meant to provide examples of research studies performed at Children’s Health and does not constitute an exhaustive list.
4. SCOPE
This SOP applies to all individuals conducting research at Children’s HealthSM.
5. RESPONSIBILITIES
5.1 CHRA Quality Specialist
1. During Performance Site Review of study application and supplementary materials, QS member assigned to review the project will identify the age range of the patient population under study and ensure consistency across documents including the protocol, IRB application, and any other supporting documents.
2. QS to confirm with members of the study team (PI, PRC, PAC) whether patients ≥ 19 years of age will be seen for recruitment and study related procedures at Children’s or other performance sites (Clements, PHHS, UTSW Ambulatory facilities, Other Locations) if not clear in the eIRB application.
3. For studies where the research team has identified a patient population ≥ 19 years of age and Children’s Health is identified as a performance site where recruitment and study related activities are taking place, the assigned QS specialist will provide members of the research team with the link to the C-360 Intake Form. A Quick Reference Guide (QRG) has also been created for members of the research team to utilize as they submit an on-line request in C-360. All clinical research studies with the intention of recruiting patients 19 years of age or older must enter the request via children’s Health’s Compliance 360 (C-360) system.
4. Once a request is submitted by a member of the study team, an e-mail notification is generated from C360 and received in the Research Department mailbox. The email will identify the PI’s name, STU#, and Velos# much like the example below:
5. The assigned QS team member tasked to review the study for Children’s Health performance site approval consideration will log into C360, select “Research” tab, locate the completed intake form, and review the documentation in full.
SOP No. 22, 06-02-22