Page 359 - 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
ARTICLE I. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed when the site is responsible for managing investigational devices at Children’s Health System of Texas (CHST).
ARTICLE II. INTRODUCTION
Research Administration (RA) is dedicated to brining innovative treatment avenues to our patients. As leading pediatric health care providers, we are equally invested in ensuring that our operations follow the governing laws and regulations around safety and compliance. The current SOP outlines the relevant contacts, policies and procedures to be followed for managing investigational devices.
Research Study Personnel who conduct clinical device trails will follow the procedures outlined in this SOP . Additionally, Research Administration (RA) leadership and Purchasing & Supply Chain Departments will work collaboratively to ensure that the purchasing, ordering, storing and use of the medical devices follows all governing regulations and policies, as well as the contractual and budgetary agreement terms.
ARTICLE III. SCOPE
This SOP applies to RA study team who will be responsible for facilitating or managing the purchasing and ordering of medical devices and supplies for clinical research.
ARTICLE IV. RESPONSIBILITIES
The team leads and study coordinators and associates need to ensure that all study approvals have been fully executed and that a SOP developed specifically for their study has been drafted and reviewed by the principal investigator (PI), purchasing manager (if applicable), and ancillary manager where the device(s) will be stored. The SOP can incorporate general guidance from this SOP and adapt it to serve the compliance needs specifically.
ARTICLE V. SPECIFIC PROCEDURES
Section 5.01 Purchasing & Ordering Study Related Medical Supplies & Devices
Investigational Medical Devices (see a sample SOP for a particular study)
(a) Complete the Device Management Checklist (see attached)
(b) Once checklist has been completed and all approvals granted: coordinate with your PI, team lead, sponsor, purchasing manager (if applicable), and ancillary manager where the device(s) will be stored.
(c) Once confirmation and approval has been granted to order, a P.O. will be created by the purchasing department. This should be stored in the regulatory binder and tracked on the accountability log, and forwarded to supply chain.
(d) With the P.O. supply chain will generate an order and shipment request. You should ensure at the start of the study that the correct address, and staff are included in the delivery and contact information (IRB approved members).