Page 82 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-006
SOP Title: Study Initiation: eResearch Systems
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to describe the standard procedures for creating a research study within the VELOS and eIRB system.
2. INTRODUCTION
All research involving human subjects must be submitted for review and approval by the Institutional Review Board (IRB). Studies can fall within 3 categories (Exempt, Expedited, or Full Board).
Velos is a study management tool used to help investigators manage the set up and day-to-day activities of human research studies. A new study should always be started within the Velos system first. Information entered can be interfaced with EPIC once the study begins to track patients.
eIRB is a paperless submission and document routing system that is used to submit new studies, continuing reviews, modifications, study closures, adverse events, etc. related to human research studies.
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. In some cases, a UTSW regulatory team lead may complete the Velos Study Registration, as well as eIRB and EPIC Integration. The CRC/A should confirm with their team lead about who will assume the responsibility, and observe the No SOA No Work rule before beginning work. The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP Securing Reimbursement for Research Study). The remainder of this SOP outlines the steps to be taken in the event that a CHST team member will complete the Velos Registration.
4. RESPONSIBILITIES
i) Determine “Review Type” to define level of review the research study requires (Exempt, Expedited, Full Board)
ii) Project summary/protocol must be written
iii) Consent forms, HIPAA forms, and any additional matter should be in UT Southwestern Medical Center IRB format
iv) Employee delegated to complete regulatory functions has been credentialed at Children’s Medical Center
v) Study team members have completed all required IRB Training through UT Southwestern Medical Center
vi) Access has been granted for both Velos and the eIRB system
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