Page 225 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING Research Administration PROCEDURE
SOP No: Q016 SOP Title: Standard Review Assessment
of IRB and PSR submissions, research staf f member will be responsible to also 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 draf t an on-line Service Now request to Standard Review (SR) for assessment of qualifying device/technology.
With assistance from the assigned QS, members of the research team will review and answer determination questions (see below) prior to SR request submission.
For device/technology that requires SR assessment, research staff member will be responsible to provide contact information of study sponsor or contact CRO representative working on behalf of the sponsor for device/technology related questions during SR review. Research staff member will be responsible to provide literature on device/technology (MDS2 or SOC2) security.
4.2 Research Administration Quality Specialists
As part of review, QS team members will assess the type of data being collected (PHI, No PHI) and how the device will interact with the Children’s Health network.
Quality Specialists will first query members of the research team with the following questions:
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 Healthinternalnetwork? Ifno,thesystemordevicewillneed 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?
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