The site initiation visit (SIV) marks the shift into action: the site is validated, approvals are in place, and the team is about to enrol its first patient. Its role is to make sure everyone starts with the same understanding of the protocol and procedures, in line with Good Clinical Practice (ICH E6).
What initiation covers
- Training the investigator and team on the protocol, eligibility criteria and assessments
- Study procedures: randomisation, investigational product handling, adverse event reporting
- The data flow, the case report form (eCRF) and source documentation rules
- Checking the investigator site file (ISF) and essential regulatory documents
- Roles, task delegation and points of contact
Why it prevents costly deviations
Most major deviations trace back to a rushed initiation: a misunderstood criterion, a loose consent procedure, uncontrolled product storage. A careful initiation aligns the team before the first enrolment — the moment when mistakes are most expensive.
How I work
I run a focused, practical session built around the protocol's risk points, then confirm in writing that the site is ready to start. I leave the team with clear expectations and record any reservations to clear before the first monitoring visit.
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Reference: ICH E6 (Good Clinical Practice).