Page 212 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q008
TO: FROM:
INSERT PI’S NAME HERE/COORDINATOR’S NAME
VICTORIA BROWN, PH.D.
DIRECTOR, RESEARCH ADMINISTRATION
EXPANDED ACCESS PROGRAM / COMPASSIONATE USE PROTOCOL –
This memo is being sent to acknowledge receipt and/or review of the below listed items in connection with your IRB application for Patient Expanded Access Protocol / Compassionate Use Protocol referenced in the subject line above.
• Protocol
• IND Application
• Letter of Authorization from Sponsor
• Informed Consent
• Investigational Brochure, and
• IRB Approval Letter
• Other pertinent documents if available (IND Attestation letter, FDA 1572, etc.)
We also verified that you are credentialed at Children’s Health – Children’s Medical Center Dallas to perform the procedures and/or administer the drugs required in the protocol.
Pursuant to Children’s Policy 7.44 (Research Adverse Event Reporting), Children’s Health mandates that all local adverse events classified as serious, unexpected, and likely or possibly related to this protocol, be reported within five (5) working days to the following email address: researchadverseevent@childrens.com. This reporting requirement is in addition to the reporting requirements of the IRB at UT Southwestern. You must also complete an eSET according to AD (# 2.13) – Report of Unusual Incidents.
If you have any questions and/or concerns regarding this acknowledgement, please contact our Research Administration Director, Dr. Victoria Brown, at 214-456-8560.
Please retain a copy of this memo in your files. Thank you.
SUBJECT:
TITLE (IRB #XX-XXXX-XXX)
DATE:
SOP Title: Expanded Access Program / Compassionate Use Protocols
RESEARCH ADMINISTRATION
SOP No. 7, Date: 4/20/16, 11/29/18; 08/19/21, 05/31/22