Page 276 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
Examples of studies that do not meet the requirement:
1. Retrospective Chart Review of Clinical Records
Research Administration SOP No: Q020
SOP Title: Adult Research Patient at Children’s Health
2. Prospective studies Children’s providers (e.g. nurses, PT, etc.)
3. Prospective studies of UTSW providers (e.g. faculty, resident, fellows, medical students, etc.)
4. Prospective studies with patient population < 19 years of age and their parents/LAR
5. Prospective, non-interventional studies (use of survey, questionnaires) where the study population includes ≥ 19 years of age
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 “Adult Patient Recruitment” form will need to be sent to the PI and members of the research team to complete.
4. QS will also enter the project in the “Adult Patient Recruitment Study Tracker” and in REDCap.
5. Completed adult patient recruitment forms that are received will be filed in the “Deb Town Folder” based on monthly submissions.
SOP No. 22, 02-18-2020