Page 26 - eBook Version 8 Book 1 of 2 JUL 2022

Study Team
Team Lead
Victoria Brown
UTSW G&C
Cross Institutional Study process (Department of Pediatrics)
UTSW Peds G&C will determine who will complete regulatory start up.
CMC support is needed for regulatory start up
NO
UTSW Peds G&C will initiate regulatory start up including completion and submission of Lab Pre-Review form.
UTSW Peds G&C will forward study regulatory documents to VB and request CTS
Receive CTS and work with Jayni George to draft SOA.
Forward fully executed SOA to VB and RA Finance at Children’s
As IRB approval is in the process, study will begin transitioning to the study team.
Forward study information to UTSW Peds G&C (Julie Long & Amanda Lee)
Assigned coordinator will complete coordinator time sheet within 5 business days of protocol receipt.
Assigned coordinator will discuss completed CTS with TL.
Study approval process will continue.
YES
UTSW Peds G&C will forward request and all required documents to Victoria Brown (VB).
VB will email documents to Team Leads (TL).
Once approved VB will save and forward to UTSW G&C. .
TL will assign study to coordinator and begin working on the CTS and Laboratory Research Support Services Pre- Review (Lab Pre-Review)/ Laboratory forms..
Is Lab Pre-Review form complete?
NO
TL will review and forward completed CTS 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/ laboratory sheets 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
Pre-Review/ laboratory sheets to VB and schedule time to review as soon as possible but no later than 14 business days of protocol receipt.
TL will review and forward completed CTS and Lab
03/30/2020
Start Up