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STANDARD OPERATING Research Administration PROCEDURE
SOP No: Q016 SOP Title: Standard Review Assessment
• Medical Diagnostic equipment on loan from study sponsor (infusion pump, ECG, etc.) - These devices do not have a dedicated encryption or other internal securities built into the device for protection of the data. Given they are portable in nature, these pose a security risk.
Non-Qualifying Devices/Technologies – Members of the research team will need to apprise the RA Quality Specialist regarding the use of any non-qualifying devices/technologies being used in the study.
• Peripheral (e.g. monitor, mouse, keyboard).
• Any project or engagement with no Children’s confidential data, to include no ePHI, creation, storage, access, or transmission nor network connectivity requirements.
• Projects/studies using a Website for data entry (no ePHI)
• Children’s Health approved hardware (e.g. servers, desktops,
laptops, network gear, iPad, phone, iWatch)
• Devices with no operating system (e.g. SSD)
• Devices that do not process, store, transmit, or access Children’s Health data or network (e.g. TV network)
• UTSW purchased technologies (iPad, laptop) being brought over from UTSW to use at Children’s
3. TEAMS
A. QualitySpecialist,ResearchAdministration
Kita Cathey, M.Ed., CHC, CHRC, CHPC
W. W. Caruth, Jr. Center for Pediatric Translational Clinical Research Clinical Research Quality Specialist
Mike Molai, B.S.
W. W. Caruth, Jr. Center for Pediatric Translational Clinical Research Clinical Research Quality Specialist
Andrew (Andy) T. Hebert, MA RRT CCRC Version 5, 02-19-2021, 08-19-21, 05-31-22
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