Page 485 - eBook Version 8 Book 1 of 2 JUL 2022

Site Initiation Visit Research Administration SOP No: R-Com-201 SOP Title: Site Initiation Visit
the study coordinator ensures that all essential documents and study SOPs have been correctly completed and filed into their respective binders. All study team members and relevant ancillary support should have completed all GCP, protocol, and sponsor required trainings with their certificates correctly filed in the regulatory binder. All accesses in all regulatory and study specific systems should be granted to all relevant study team members prior to the SIV.
4.2 SIV Scheduling
The expectation is that the primary study coordinator schedules the SIV with all stakeholders, reserves the appropriate resources to fulfil the SIV objectives, and creates an agenda to outline the timing of events and those required to participate. The agenda will be constructed in such a way so as to allow the parties to attend their role specific training. Additionally, effective SIV planning will ensure that each study team member is regulatory compliant and recorded accurately in the sponsor and site’s regulatory files.
5. PROCESS
5.1 Study Approvals
At the time of the SIV, the following procedures must be completed or initiated as indicated below:
• IRB approval must be obtained
• Performance site approval (PSA) must be approved
• Facility use agreement (FUA) must be initiated
• Study contracts must be completed
5.2 Sponsor/CRO/Sponsor Agent Contact
The study team will confirm with involved parties prior to SIV scheduling that all study documents have been received, and provide any additional documents as needed
5.3 SIV Scheduling
The expectation is that the primary study coordinator schedules the SIV with all stakeholders, reserves the appropriate resources to fulfil the SIV objectives, and creates an agenda to outline the timing of events and those required to participate. The study team will notify Research Administration Administrative Coordinator of the following SIV specifics prior to the visit:
• PI name
• Study name and IRB number
• Dates that the sponsor/CRO/sponsor agent will be on site
• Locations that will be visited during the SIV
5.4 SIV Components
Generally, the sponsor will provide the required components of the SIV prior to the visit to the site. These components may include but are not limited to:
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