Page 171 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q002 SOP Title: Lapsed IRB Study Process
B. Include in body: Title / IRB# / PI name / Any other relevant information
C. Email will be sent within three (3) business days of IRB notification of study lapse to
the Children’s Research Administration
5.3 For studies that do not have documentation of CMC site approval, Quality Specialist composes a follow-up email to the Principal Investigator / Research Coordinator (PI / RC) requesting submission of performance site review. The email to the PI / RC will include:
A. Subjectline:“ACTIONREQUIRED:PERFORMANCESITEREVIEWREQUEST”
B. Include in body: Title / IRB# / PI name / Any other relevant information
C. Email will be sent within three (3) business days of determination that site approval
has not been granted
D. Clinical Manager of the Research Administration and Director of the Research
Administration will be copied on the email notification to the PI / RC
5.4 The lapsed study tracking report is reviewed by members of the QS team on a regular basis and updates are made accordingly.
5.5 For projects that continue to be in lapsed status longer than one month, members of the QS team reach out to the UTSW IRB to determine reason(s) why the study has not been closed either by the PI or by the UTSW IRB.
A copy of Performance Site Review Request template is located in SOP #3 – Performance Site Review / Approval Process.
6. PROCESS MAP
7. CHANGE HISTORY
Research Administration
Notifies Principal investigator, Research Coordinator, Clinical manager, & Research Director that study has lapsed within 3 days of IRB notification.
IRB
Automatically generated IRB email notifies research Administration that study has lapsed.
Medical Director
Notified on 3rd lapse notification & contacts Division Director of PI’s home department.
Start
End
SOP no. 2
Effective Date
Significant Changes
Previous SOP no.
Q002
08/01/2022
•Addition of Andrew (Andy) Hebert as an author
•Updates to Appendix A letter
Q002
SOP No. 2, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 10/13/16; 11/29/18; 03/18/19, 05/31/22