Page 61 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-004 SOP Title: Study Initiation with Pharmacy
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline procedures to be followed when using the pharmacy for a drug investigational study at Children’s Health System of Texas (CHST).
2. INTRODUCTION
Advancing care is a collaborative effort of the sponsor, institution, and study team to systematically test the safety, efficacy, and therapeutic dose of an investigational product (IP). In effort to carry-out the clinical trial in a manner that allows for a therapeutic effect to be determined, the investigator, or study doctor, must oversee the management of the IP with the investigational drug services pharmacy.
The IDS pharmacy team member and contact information are listed below.
Team Members:
Jordan Whitehill, PharmD, BCPS – Manager Kelly Peschke, PharmD
Troy Boxum, CPhT
Contacts:
Email: IDSRx@childrens.com
Phone: 214-456-2924 Kelly Peschke, PharmD Fax: 214-456-8073
Investigational Product Mailing Address:
Children’s Medical Center Dallas
Pharmacy / Investigational Drug Service Mailcode DL.03 1935 Medical District Dr
Dallas, TX 75235
Hours of Operation:
Monday – Friday 8:00am – 4:30pm
If pharmacy is needed outside of these hours, notify the team and alternative plans can be arranged.
3. SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Health System of Texas (CHST). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team
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