Page 67 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Site Evaluation Visit Research Administration SOP No: R005 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 Medical Center at Dallas. 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 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 the team lead to assess feasibility analysis and complete the CTS and laboratory feasibility questionnaire.
5. PROCESS
5.1 SEV Scheduling
5.1.1 Schedule and arrange the site evaluation visit as requested by a sponsor representative. Attendees may include sponsor representative(s), the PI, Investigators, other clinical research personnel, pharmacy, research laboratory personnel and other ancillary staff as deemed necessary by the sponsor.
5.1.2 Schedule a tour of the facilities to be conducted during the pre-study evaluation visit.
5.2 SEV Components
5.2.1 The tour should establish that the necessary equipment and capabilities for equipment (e.g., internet lines, phone lines, etc.) are available, that there is adequate space to conduct the study, and that there is a secure, limited-access area for study supplies and investigational product storage.
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