Page 277 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R104 SOP Title: eIRB Modifications
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the creation, editing, and submission of a modification within the eIRB system.
2. INTRODUCTION
Once a protocol is approved by the Institutional Review Board (IRB), any subsequent changes require a modification which must be reviewed and approved by the IRB prior to implementation. To request approval of a proposed modification, complete and submit an eIRB Modification SmartForm.
When completing the Modification form, you will answer questions and provide supporting documentation and information for the changes you are making to your study. The Modification form will direct you to upload a red-lined copy of revised documentation, as well as provide you with a link to the parent protocol, where you will upload a “clean copy” of the revised documentation. (The only time you will not update the parent study for a modification is when you change the study personnel). A modification can only be completed on an Approved protocol.
3. SCOPE
This SOP applies to Research Coordinators, Associates, Sub-Investigator, Co- Investigator or Principal Investigator and any other staff members delegated the task of regulatory functions involved in the study.
4. RESPONSIBILITIES
i) Employee delegated the task of regulatory functions within the study has been credentialed at Children’s Medical Center.
ii) Request access for IRB by completing the required training.
iii) 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. SPECIFIC PROCEDURE
5.1 Log into eIRB
i) Type this link in your web browser: https://eresearch.swmed.edu/eIRB/
ii) Type your login ID in the User Name field and password (as you would normally type it).
a. This could be your UT Southwestern Medical Center, Children’s Health, or Parkland Health and Hospital System credentials.
b. When given access to the eIRB system an email stating which credentials to use should have been listed.
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