Page 222 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING Research Administration PROCEDURE
SOP No: Q016 SOP Title: Standard Review Assessment
1. INTRODUCTION & PURPOSE
The Standard Review Committee (SRC) exists to provide a multi- functional representation of key areas within Information Services, to establishthestandardsforsoftwareandhardwarenecessarytosupport the business needs of the Children’s Health System of Texas (CHST). Additionally, to review, evaluate, and provide recommendations for any addition of new software and/or hardware based on technology changes, business needs, or organization growth.
Research Administration (RA) and SRC at Children’s HealthTM have developedaprocesstoverifythatmedical devicesortechnologies used in research and interacting with Children’s Health Wi-Fi network are secure and have enabled protections to safeguard data (de-identified, identified, or limited data set) that is being transmitted to external partners (outside of Children’s/UTSW environment).
2. SCOPE
This SOP applies to all study applications submitted to the IRB which lists CMC as a performance site.
Qualif ying Devices/T echnologies –
• Biometric Devices (e.g. Fitbit) - FitBits’ do not have an operating system but do store data and this could be downloaded to Children’s network wirelessly
• Sponsor issued technologies (laptop/desktop/e -Diaries) – These devices typically do not have Children’s encryption and security software loaded on the unit. Any data that is being transmitted across Children’s network may be at risk of exposure
• 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) Version 4, 02-19-2021, 08-19-21
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