What's inside
The checklist follows the visit end to end, so nothing gets discovered at the wrong moment. It's organised into nine sections you can work through in order.
Before the visit
- Date, format & attendee list confirmed
- Essential documents and approvals current
- Contract, budget and consent versions ready
- Delegation log drafted for signature
During the visit
- Roles, delegation and training coverage
- Protocol, eligibility and visit schedule
- Consent process and re-consent triggers
- Safety reporting definitions and routes
Operations
- Investigational product storage & accountability
- Lab logistics, kits and sample handling
- Equipment calibration and certifications
- Study system access and data timelines
After the visit
- Follow-up letter and minutes reviewed
- Action items assigned with owners and dates
- Delegation log finalised and signed
- Activation criteria met before first enrollment
Honest note: this is a general starting framework, not regulatory advice. Adapt it to your protocol, sponsor requirements, and organisational procedures, and route it through your own review before operational use.
Free PDF vs. the editable template
The download on this page is a read-only PDF — print it, work through it, share it with your team. If you'd rather have a version you can edit, brand, and adapt to each study, the editable Word document is available in the marketplace, along with the wider site-startup set.
Need the editable version?
The Site Startup Bundle includes the editable SIV checklist plus 11 more startup documents — feasibility, SQV/SIV reports, delegation log, training log, and the regulatory binder checklist.
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