A gate, not a formality
Enrollment doesn't open on a scheduled date — it opens once the SIV confirms training, documents, and supplies are actually in place.
What's included
What the SIV confirms before enrollment opens
- Confirmation that site and CRA protocol training is complete for every study role at the site
- Essential document review, confirming regulatory, contract, and budget items are filed and complete
- Investigational product and supply accountability set up, including storage, dispensing, and reconciliation logs
- Walkthrough of source document and eCRF completion expectations with site coordinators
- A documented site-ready determination, with any open items tracked to closure before enrollment is authorized
Built on activation, not around it
The SIV follows directly from site activation, so readiness is checked once contract, budget, and regulatory approval are already cleared.