Page 131 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q002 SOP Title: Lapsed IRB Study Process
B. Includeinbody:Title/IRB#/PIname/Anyotherrelevantinformation
C. Anemailwillbesentwithinthree(3)businessdaysofIRBnotificationofstudylapse
to the Children’s Research Administration
5.3 For studies that do not have documentation of CMC site approval, QS 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. Includeinbody:Title/IRB#/PIname/Anyotherrelevantinformation
C. Anemailwillbesentwithinthree(3)businessdaysofdeterminationthatsiteapproval
has not been granted
D. The Director of the Research Administration and QS 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
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Q002
12/01/21
Add Andrew Hebert
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; 08/17/2021