Page 125 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to describe the process for managing IRB email notifications from UTSW.
2. INTRODUCTION
Children’s Research Administration receives research-related email notifications from UTSW IRB in the Research Department mailbox titled ‘Research_Department Inbox’. The Quality Specialists team owns the management of the mailbox. The other owners of these emails are noted below.
3. RESPONSIBILITIES
Quality Specialists along with designees are tasked to move email types into assigned subfolders. Each owner below will be responsible for managing their assigned subfolder.
Owners: Quality Specialists
• Service Package Requests (SPG) – File all communication related to SPG requests
• CMC – Mod Approved (Refer to SOP No: 6 UTSW Institutional Review Board ModificationApprovalNotificationSOPformoredetails)- Attheendofeach business day, a member of the Quality Specialists team or designee will review the Research mailbox for Modification approval notifications. For personnel changes, verification of credentialing as well as completion of Children’s Research Administration (RA) required training will be performed. Research site personnel will be contacted if new staff members are not credentialed and have not completed RA required training. This process will be tracked on a shared Excel spreadsheet.
• Submit Study – CMC Review (Refer to SOP No: 8 Study Approved – CMC as a Clinical Site for more details) – A member of the Quality Specialists team will log study in a tracking spreadsheet, and depending on the nature of the study, an introductory email will be sent to the researcher which includes some the following requests:
▪ SupportJustificationforfinancialandpersonnelsupportformand instruction sheet
▪ Directresearcher(PI/PRC)tofollow-upwiththeirdepartment Grants and Contracts specialist to initiate an SOA. For department of pediatrics, request should be sent to: “pedsresearch@UTSouthwestern.edu ”
▪ Fordevicestudies,adevicetrackinglogwillbesenttothe researcher. Standard Review may also be warranted.
▪ DelegationofAuthorityLog(fornon-industrysupportedprojects) SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020