A Site Initiation Visit (SIV) is a meeting conducted to inform the investigator(s) and study staff about the details of study procedures. This meeting occurs after the Pre-Study Visit (where required) and a qualified Principal Investigator (PI) has been selected, after all regulatory paperwork is collected, Institutional Review Board approval is obtained, test article is received at the site and the investigator(s) is (are) ready to enroll subjects. Following this visit, the site can then begin to recruit subjects into the study.
This visit may be waived if the site has worked with the sponsor within the past 12 months in a similar therapeutic research trial or if the PI and investigational site staff attended the protocol specific Investigator Meeting.