Page 374 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-004
SOP Title: Management of Medical Supplies & Devices
Standard Operating Procedure: Device Management
Study: Prospective, non-randomized pivotal clinical study to assess the safety and efficacy of the bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction
PI: Robert Jaquiss, MD
IRB: STU-2020-1196
Velos: 31975
Name
Email
Phone
Role/Entity
UTSW PI
UTSW Co-PI
Xeltis Consultant
Project Manager
CRC
Back-Up CRC
Back-Up CRC
TL Nursing CT Surgery
Clinical Manager Heart Center Admin
Purchasing
Confirm Shipping Addresses:
CHST (Arrival)
Xeltis (Return)
Rodneisha Powell
Children’s Medical Center of Dallas Dallas, TX 75235
Mail Drop: B3.09 Wayfinder: C3253
Xeltis Inc. Attn: Jennifer Braughton 9391 Grogans Mill Rd.
Suite A6
The Woodlands, TX 77380