Page 266 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

Children’s Health W. W. Caruth, Jr. Center for Pediatric Translational Clinical Research Standard Review Request for Research Devices/Technologies Tip Sheet
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”.
12345 Are non-Children’s
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)?
Will the system, device, or interface connect to the Children’s Health internal network? If no, the system or device will need to connect the Guest/Business Guest networks.
Is technology (software, applications) being installed onto the Children’s Health environment?
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.
Are there any architectural changes or uses of an existing implementation or a previously reviewed request?
Yes No No No No No
Yes
Yes
Yes
Yes
It should be noted that the following scenarios will require Standard Review assessment:
1. Any project that will utilize “cloud” storage or computing infrastructure (e.g., Dropbox, Amazon Cloud Services, EC2).
2. For any project where an external or vendor systems will attempt to integrate with a CMC system, e.g., Children’s EPIC
3. Studies that will create and utilize a mobile application to be used on Children’s issued devices (iPad, iPhone, tablet, etc.)