Page 323 - eBook Version 8 Book 1 of 2 JUL 2022

Closeout Checklist
Study Team Responsibilities to Sponsor
Select
Comments
Have all study activities been completed?
Yes No
Have all regulatory responsibilities been satisfied or completed?
Yes No
Have all unused investigational products been returned or discarded per sponsor and institutional policies?
Yes No
Have all sponsor requests including answers to monitor question/clarifications been adequately addressed?
Yes No
Have you been informed that study data has been locked for assessment? Has assessment been completed?
Yes No
Have you received notification from your study sponsor to closeout your study with the IRB?
Yes No
Have you submitted to your sponsor a copy of your acknowledged closeout notification letter from the IRB?
Yes No
UTSW Sponsored Program Administration
Select
Comments
Have you contacted SPA to inform them that you have received approval to close your study from the study sponsor?
Yes No
Have you confirmed that all invoices have been issued to your study sponsor prior to study closeout?
Yes No
Velos & IRB
Select
Comments
In Velos, have you updated your participants to “Off Study” and “Disassociated with Study in CMC EMR”?
Yes No
In Velos, have you updated the study status to “Study-Terminated”?
Yes No
In eIRB, have you requested for study closure? And, did the IRB acknowledge the closure?
Yes No
Children’s Health Performance Site
Select
Comments
Have you contacted Children’s Health Finance Team to inform them that you are planning to closeout your study? Have all outstanding invoices from Children’s Health to UTSW been paid?
Yes No
Has study status been updated in the research finance systems?
Yes No
Have you reached out to all supporting departments (e.g. IDS, Radiology, Pathology, Cardiology and Laboratory) at Children’s Health to inform them that you are closing out the study?
Yes No
Have you reached out to Research Administration leadership to inform them of the long term location of study regulatory and participant binders
Yes No
Version Date: 7/28/17