Page 557 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Device Description:
Research Administration SOP No: R-Adm-002
SOP Title: Management of Medical Supplies & Devices | Storage Room & Cubicle Guidance
Receiving New Shipments of Devices:
CRC to coordinate with Xeltis Robert Kroslowitz on intended shipment and date of arrival of devices and
Rodneisha Powell, and Delitra Houston.
Upon mutual date of shipment at Wayfinder: C3253, a calendar invite will be sent to Rodneisha, Delitra, and Jennifer.
Once shipment is received, CRC will meet Rodneisha and confirm the contents with her presence. Chain of custody form will be signed, dated and timed.
Devices will be taken to the: Surgical Core under the management of Delitra. Temperature requirements will be confirmed, and research devices set apart and labeled from standard of care devices.
Temperature monitoring device will be activated and plugged in USB (see appendix with steps)
Accountability log will be completed, a copy scanned and efiled on the HC shared drive, and a copy emailed to the PI, Co-PI, CRCs, Delitra Houston, Rodneisha Powell, and sponsor. Chain of custody form will be signed, dated and timed.
Utilizing the Devices for Research Patient Implantation:
Once potential subjects are identified, a notice will be sent to: CRCs, Delitra Houston, Rodneisha Powell, and
sponsor.
Once eligibility is confirmed and surgeries are scheduled, the date of implantation will be sent in a calendar invite to the CRCs, Delitra Houston, Rodneisha Powell, and sponsor.