Sites & Operations
Site Initiation Visit (SIV)
A Site Initiation Visit (SIV) is the formal sponsor-led training and activation visit conducted at each clinical trial site immediately before the site is authorized to begin enrolling participants, typically following IRB approval and contract execution.
The SIV covers protocol training, GCP review, IP handling, randomization, EDC and eCRF training, AE/SAE reporting, source documentation expectations, and emergency procedures. Completion of SIV with documented training is a prerequisite for the site's green-light to enroll.
After SIV, the site is considered activated; activation date is a key startup KPI tracked across the portfolio.
Related terms
Site Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the on-site or remote evaluation conducted by a sponsor or CRO before site activation, to confirm that a candidate site has the personnel, facilities, processes, and patient access required to conduct the planned clinical trial in compliance with GCP.
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
Good Clinical Practice (ICH E6(R3))
Good Clinical Practice (GCP), as defined in ICH E6(R3), is the international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human participants.
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