Page 86 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Study Team
Team Lead
Victoria Brown
UTSW PI’s Department
Cross Institutional Study process (Non-Department of Pediatrics)
UTSW department will determine who will complete regulatory start up procedures.
CMC support is needed for regulatory start up?
UTSW department will initiate regulatory start up
UTSW department will forward study regulatory documents to VB and request CTS.
Receive CTS and SOA
Forward fully executed SOA to VB and RA Finance at Children’s
As IRB approval is in process, study will begin transitioning to the study team.
Forward study information to appropriate department and Victoria Brown (VB): -PedSurg/Transplant Nadia Nassaj
-Ortho Surg (TBD)
-Urology Monica Villagomez (grants management)
Assigned coordinator will complete coordinator time sheet (CTS) within 5 business days of protocol receipt.
Assigned coordinator will discuss completed CTS with TL.
Study approval process will continue
YES
UTSW Department will forward request and all required documents to Victoria Brown (VB).
Forward executed Regulatory SOA to VB
NO including completion and
submission of Lab Pre-Review form.
VB will email documents to Team Leads (TL).
Receive and review regulatory SOA. Forward on to UTSW department for execution.
Receive/notify TL and Coordinator that regulatory activities may commence.
Once approved VB will save and forward CTS to UTSW department. The pre-SOA will be entered into a share folder with Jayni George.
TL to draft regulatory SOA
coordinator, and begin working on pre-SOA and CTS
Is Lab Pre-Review form complete?
TL will assign study to
NO
TL will review and forward completed CTS along with pre-SOA to VB and schedule time to review as soon as possible but no later than 14 business days of protocol receipt. TL will work with assigned coordinator to complete Lab Pre-Review form as documents become available and schedule a time to review with VB.
Send Lab Pre- Review form with protocol and lab manual to lab for review.
YES
TL will review and forward completed CTS along with pre-SOA and Lab Pre-Review to VB and schedule time to review as soon as possible but no later than 14 business days of protocol receipt.
01/10/2020
Start Up