Page 199 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q011
SOP Title: Facility Use Agreement - CMC as a Clinical Site
• If agreed, Director of Research Administration will log study in the FUA spreadsheet for further action.
• QS will send an e-mail to the PI/RC with the following request:
Based on a rendering from Legal Affairs at CMC, it has been decided that industry-sponsored clinical trials require the execution of a Facility Use Agreement (FUA). Please contact Dr. Victoria Brown, Director of Research
Administration, via an introductory e-mail to your sponsor negotiations between the two groups can begin immediately:
Victoria Brown, PhD, CCRP, CIP Director, Research Administration Children’s Health
214-456-8560 Victoria.Brown@childrens.com
so that
In your e-mail to the sponsor, please include the title of the protocol, PI name, STU#, and Velos# for tracking purposes. Please note that performance site approval will not be impacted during FUA negotiation and execution.
• While the study is under review with the IRB, QS will periodically reach out to the investigators and their coordinators who have not followed up with the Research Administration Director regarding the request.
• Concurrent to the execution of the study CTA, a FUA between Children’s Health and the study sponsor will also be processed in order to avoid long delays following IRB approval.
• During this process, Director of Research Administration will routinely update the QS team as well as others regarding FUA execution efforts.
• Following execution of the FUA, a copy of the FUA will be forwarded to QS
6. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Version 4, 10/12/16, 10/13/16, 10/27/16, 10/28/16 Page 3 of 3