Page 475 - eBook Version 8 Book 1 of 2 JUL 2022

Site Evaluation Visit Research Administration SOP No: R-Com-200 SOP Title: Site Evaluation Visit
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.
5.2.2 Provide copies of relevant, appropriate study-related materials (i.e., copy of protocol and study visit schedule) to all meeting attendees prior to the pre-study evaluation visit.
5.2.3 Provide the sponsor with:
5.2.4 Documentation of the local clinical laboratory current licensure or accreditation, along with current normal reference ranges for applicable tests.
5.2.5 Current copies of clinical site research personnel’s curriculum vitae (as required by sponsor).
5.2.6 Other certifications and/or training (e.g., International Air Transport Association (IATA) training, dry ice certification, etc.).
5.2.7 Information specific as to how research activities are conducted at the site, including the responsibilities of clinical site research personnel.
5.2.8 Institutional Review Board (IRB) requirements and scheduled meeting dates.
6. PROCEDURE PROCESS MAP
Start – Up Phase
Prior to Meeting
At Meeting D010
1) Present Training
2) Confirm Site Grant Site Approval
Information
Complete Feasibility Analysis
Obtain CDA
Schedule Site Qualification Visit with:
1) Sponsor
2) Study Team
3) Investigational Drug Service
3) Laboratory
Navigate between appointments with: 1) Study Team
2) Investigational Drug Service
3) Laboratory
Page 3 of 4
CRC / CRA Sponsor
Start
Finish