Page 170 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q002 SOP Title: Lapsed IRB Study Process
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures to be followed for the studies that enter into lapsed status with an Institutional Review Board (IRB). IRB defines ‘lapsed status’ when the continuing review of a research protocol does not occur prior to the end of the approval period stated in the IRB approval letter; the IRB approval expires automatically.
2. INTRODUCTION
Children’s Health Research Administration requires all research studies be in compliance with IRB requirements and maintain a current approved status.
3. SCOPE
This SOP applies to all IRB approved research studies.
4. RESPONSIBILITIES
4.1 Service Line Development
Children’s Health Research Administration will work with the research study team to notify the team of lapsed study and request action to maintain study status compliance.
5. SPECIFIC PROCEDURE
Utilize the following steps:
5.1 In addition to notifying the research team, the IRB notifies the Children’s Medical Center
Research Administration via an email to Research_Department@Childrens.com. Assigned Quality Specialist verifies lapse status in the eIRB and determines whether the
project has CMC site approval in Velos or ERGO systems.
Study is then logged in Lapsed Study spread sheet found at:
(\\childrens.med\depts\RESEARCH\SHARE\CLINICAL RESEARCH\Research Administration COORDINATOR\CCRCT\Quality Specialists\Lapsed Study Tracking Log & Letters – Quality Specialists\Log), and actions are documented in comments.
Assigned Quality Specialist only reaches out to members of the research team if there is no Continuing Review application created and pending review by the UTSW IRB. Studies are considered in good standing with respect to annual review requirements if a CR has been created and under review by the IRB.
5.2 Designated Quality Specialist composes an email, using template in Appendix A, to the Principal Investigator / Research Coordinator (PI / RC) following notification of study lapse from the IRB. The email to the PI / RC will include:
A. Subjectline:“ACTIONREQUIRED:LAPSEDSTUDY”
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