Page 228 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING Research Administration PROCEDURE
SOP No: Q016 SOP Title: Standard Review Assessment
Introduction & Purpose
The Standard Review Committee (SRC) exists to provide a multi-functional representation of key areas within Information Services, to establish the standards for software and hardware necessary to support 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 developed a process to verify medical devices or technologies used in research are secure and have enabled protections to safeguard data that is being transmitted outside of the covered entity.
Responsibilities
Research staff member will be responsible to review the protocol and work with the study sponsor to identify devices/technologies that are going to be utilized for use during the study. At the time of IRB and PSR submissions, research staff member will also be responsible to work with members of the CMC RA Quality Specialist team to determine whether technology or device for use in the study will require SR assessment and to submit an on-line Service Now request to Standard Review (SR) for assessment of qualifying device/technology. Prior to submission of request, the following questions need to be answered:
1. Is Children’s protected health information (PHI) being accessed, collected, stored, or transmitted (e.g. ePHI, PHI, HR, Financial, ePII, PII, etc.) outside of the covered entity (to external collaborators)?
2. Will the system, device, or interface connect to the Children’s Health internal network? If no, the system or device will need to connect to the Guest/Business Guest networks.
3. Is technology (software, applications) being installed onto the Children’s Health environment?
4. Are non-Children’s systems/devices that produce Radio Frequency (RF) being provisioned within the Children’s environment? Examples of RF devices include: 1) wireless medical telemetry systems generally used to monitor a patient’s vital signs (e.g. pulse, and respiration) using radio frequency (RF) communication and 2) cellular/mobile phone to support health care delivery.
5. Are there any architectural changes or uses of an existing implementation or a previously reviewed request?
Standard Review assessment will be required if the responses to questions 1, 2 (internal network), 3, 4, or 5 is "Yes".
Standard Review assessment will not be required if the responses to 1, 2 (Guest or Business Guest), 3, 4, and 5 are “No”.
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