Page 204 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q007
SOP Title: UTSW Institutional Review Board MOD Approval Notification Process
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe procedures to be followed when UTSW Institutional Review Board (UTSW IRB) MOD notices are received, which Children’s Research Administration receives through email notifications from UTSW IRB in the Research Department mailbox titled ‘Research_Department Inbox’.
2. INTRODUCTION
When IRB-approved studies are modified, Children’s Research Administration receives email notifications titled ‘CMC-Mod Approved’ and ‘CMC-Mod Submitted’ for modifications to approved studies from UTSW IRB. These emails are received in the Research_Department Inbox and involve personnel and non-personnel changes to the study.
3. SCOPE
This SOP applies to all UTSW IRB MOD Approval Notifications
4. RESPONSIBILITIES
4.1 Research Quality Specialist
5. For CMC-MOD Approved notifications involving the addition of new research staff, the Quality Specialist or designee will work with the research study team to determine if each new staff added has completed Children’s credentialing and training requirements. The modification will be logged on the MOD spreadsheet located on the shared drive.
For CMC-MOD Submitted notifications involving significant updates to the protocol (addition of new services, visits, etc.), members of the Quality Specialist team or designee will log the MOD at the time of MOD submission. The QS or designee will identify and log the change in question, and if the protocol modification requires an update to the service order agreement (SOA), the QS or designee will notify Research Administration staff members and request an update to the SOA.
6. SPECIFIC PROCEDURE
A. CMC-MOD Approved Personnel changes (PI, Co-I, key personnel):
• Quality Specialist (QS) or designee reviews the study staff approved by the IRB for credentialing and training completions, noting any deficiencies
• QS or designee will utilize Outlook to determine if study staff is UTSW or Children’s employee
• QS or designee will utilize the following to determine if study staff have completed the two research training courses:
o Cornerstone
o ClinicalResearchTrainingRecords
SOP No. 6, Date: 4/19/16, Revised 5/31/16; 11/29/18; 02/17/21, 05/31/22