Page 474 - eBook Version 8 Book 1 of 2 JUL 2022

Site Evaluation Visit Research Administration SOP No: R-Com-200 SOP Title: Site Evaluation 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 evaluation visit (SEV) on Children’s Health Campus.
2. INTRODUCTION
Sponsors conduct site evaluation visits, generally referred to as “site visits,” to select qualified Investigators and to determine the investigative site’s ability to conduct the clinical investigation prior to commencement of the study. In order to be selected, Investigators must be qualified by training, education, and experience and have adequate resources, staffing, and facilities to conduct the proposed investigation. In some instances, sponsors elect to allow some combination of Investigator meetings and/or an initiation visit to suffice as a pre-study evaluation visit.
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 may complete the SEV. The CRC/A should confirm with their team lead about who will assume the responsibility of the SEV. 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 SEV.
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 SEV Scheduling
The study team will work with the sponsor, CRO or sponsor agent to schedule the SEV for a time that is acceptable to all involved parties.
4.2 SEV Components
The study team will communicate the required SEV components requested by the sponsor/CRO/sponsor agent clearly to all parties involved. Additionally, upon receipt of site selection from the sponsor, the study team should work with the team lead to assess feasibility analysis and complete the CTS and laboratory feasibility questionnaire.
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