Page 484 - eBook Version 8 Book 1 of 2 JUL 2022

Site Initiation Visit Research Administration SOP No: R-Com-201 SOP Title: Site Initiation Visit
1. PURPOSE
The purpose of this standard operating procedure (SOP) is to outline the procedures to be followed when planning, scheduling and conducting a site initiation visit (SIV) on Children’s Health campus.
2. INTRODUCTION
The purpose of a site initiation visit (SIV) is to ensure that a site has all of the documentation and resources inline prior to study activation. SIV’s are conducted by the sponsor, contract research organization (CRO) or agents acting on the sponsors behalf. The SIV must occur before patient enrollment can begin and/or shipment of investigational product/device. Action items will be addressed at the SIV and are to be completed prior to site activation. Critical players in these visits include but are not limited to:
• Principal Investigator (PI) and/or Sub-Investigator (Sub-I)
• Clinical Research Coordinator (CRC) and/or Clinical Research Associate
(CRA)
• Investigational Drug Service (IDS) Team (if applicable)
• Research Laboratory staff (if applicable).
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 case, a UTSW regulatory team lead, Amanda Lee, Amanda.lee@UTSouthwestern.edu may complete the SIV. The CRC/A should confirm with their team lead about who will assume the responsibility of the SEV and SIV. The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP CTS and Transition Time Sheet). The remainder of this SOP outlines the steps to be taken in the event that a CHST team member will complete the SIV.
4. RESPONSIBILITIES
All onsite sponsor visits are expected to follow the on-site sponsor guidance attached the back of the SOP. All sponsor representatives coming on site are expected to provide a vaccine attestation and obtain approval to come on site at least 10 business days prior to the day of the visit. Additional requirements extend to representatives that will go into the clinic spaces. Remote access to EPIC requires a Monitor Access Form to be completed 10 business days prior to the day the access is needed.
4.1 Study Approvals
The study team will ensure that all applicable study approvals have been requested and granted. The primary study coordinator will ensure that the study team is fully apprised of the study and prepared to demonstrate sufficient comprehension of the study and how the study will be conducted at the performance site. It is important that
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