Page 210 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q008
SOP Title: Expanded Access Program / Compassionate Use Protocols
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed for the Investigational Drug/Device studies that are received at Children’s Health for the Expanded Access Program (EAP) / Compassionate Use Protocol (CUP)
2. INTRODUCTION
Children’s Health Research Administration will be notified of single patient EAP/ CUP using the ‘Research_Department Inbox’. The Quality Specialists (QS) team owns the management of the mailbox. The Quality Specialists have included their steps for processing the notification of EAP / CUP. A Performance Site Review request will not be required for these types of projects. Moreover, a Performance Site Approval will not be issued in Velos. Instead, an Acknowledgement Letter will be issued by Children’s Research Administration to the Principal Investigator (PI) following review of all study related materials. It should be noted the PI will assume the same responsibilities that are mandated by Children’s HealthSM Children’s Medical Center Research Administration policies as other research projects conducted at Children’s Medical Center campus.
3. SCOPE
This SOP applies to all departments conducting research at Children’s Health.
3.1 Children’s Research Administration
The Quality Specialists (QS) will work with the research team submitting an EAP / CUP to verify credentialing of study team and receipt and/or review of the following:
• Protocol
• IND Application
• Letter of Authorization from Sponsor
• Informed Consent
• Investigational Brochure, and
• IRB Approval Letter
• Other pertinent documents if available (e.g., IND Attestation letter, FDA 1572, etc.)
4. SPECIFIC PROCEDURE 4.1 Scope EAP / CUP Process
• Children’s Health Research Administration receives an email notification for CMC-Study Approved from UTSW IRB in the Research Department mailbox titled ‘Research_Department Inbox’.
SOP No. 7, Date: 4/20/16, 11/29/18; 08/19/21, 05/31/22