Page 261 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
− Leonard Kyle
Sr Enterprise App Analyst IT Security
− James Lovaglio
Security Operations Center Analyst IT Security
4. RESPONSIBILITIES
4.1 Research Staff Member Responsibility
Research Administration
SOP No: Q016 SOP Title: Standard Review Assessment
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 course of the study. At the time of IRB and PSR submissions, research staff 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 draft 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.
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