Page 234 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q011
SOP Title: Facility Use Agreement - CMC as a Clinical Site
sponsor so that negotiations between the two groups can begin immediately:
Deborah (Deb) Town, RN, MSN, CCRC, CHRC Senior Director, Research Administration Children’s Health
214-456-8560
Deborah.Town@childrens.com
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 for their files. Please note that a copy of the fully executed FUA should not be forwarded to members of the study team.
5. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q011
08/01/2022
• Removal of Jayni George
• Addition of Andrew (Andy) Hebert
• Removal of Victoria Brown
• Reference to Director of Research Administration changed to Senior Director of Research Administration
• Added Designee
• Updated Email address: Deb Town instead of Victoria Brown
Q011
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