Page 207 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-105 SOP Title: eIRB – Continuing Review
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures to be followed when a study has a continuing review within the eIRB system.
2. INTRODUCTION
A Continuing Review (CR) is a yearly document that outlines enrollment numbers, problems associated with the study, and progress of the study. When an IRB approved study is due for a Continuing Review, the Principal Investigator (PI) and the Clinical Research Coordinator (CRC) will receive an email notification prior to study expiration date. The IRB will send email notifications to study staff at 90, 60, and 30 day intervals prior to the expiration date of the approved protocol. A Continuing Review is expected to be submitted to the IRB for review no later than 30 days, however, it is best practice to submit the CR no later than 60 days to ensure the study does not lapse.
Upon notification, study personnel should access the approved study in the eIRB to create the Continuing Review smart form for IRB review.
When Continuing Review of a research protocol does not occur prior to the expiration date in eIRB system, the IRB approval expires automatically. If the IRB has not reviewed and approved a research study by the study expiration date, all research activities must stop.
3. SCOPE
This SOP applies to all clinical research staff on the study team that conduct clinical research at Children’s Health System of Texas (CHST). The study team as defined in Children’s Health Clinical Practice Policy 7.12, Responsibilities of the Research Team will ensure adherence to this SOP.
4. RESPONSIBILITIES
4.1 Clinical Research Coordinator/Clinical Research Associate
The clinical research coordinator or the clinical research associate will create the continuing review and to notify the PI to submit the continuing review once complete.
Principle Investigator (PI)
The Principle Investigator (PI) is responsible for reviewing and submitting the continuing review.
5. SPECIFIC PROCEDURE
For studies using a central IRB, please follow the guidance provided in SOP Study Submissions wherein guidance for navigating a cIRB is provided. The Reliance Agreement for UTSW should be sent to: Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378.
5.1 Log into the eIRB
i) Type this link in your web browser: https://eresearch.swmed.edu/eIRB/
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