Your Site Initiation Visits Done Right
As a Project Manager (PM) working closely with Clinical Research Associates (CRAs) to manage Site Initiation Visits (SIVs), I understand how pivotal these meetings are, as they set the tone for the entire study. Done well, they accelerate activation, reduce start-up churn, and build site confidence. Done poorly, they create rework, protocol deviations, and Sponsor escalations.
Based on my experience overseeing SIVs, I have gathered a few practical tips that can make a big difference:
Prepare a reference script (not a read-aloud):
CRAs should draft a reference script that guides flow without turning into a narration of the slides. For each section, capture the key message in one or two lines, add a few proof points, and spell out a “what this means for your site” takeaway. Write the transitions and handoffs so speakers move smoothly between topics and include one or two prompts per section to check understanding and bring the site into the discussion.
Prepare answers to FAQs in advance:
Anticipate common questions, for example questions around investigational product (IP) accountability, temperature excursions, Serious Adverse Event (SAE) timelines, remote access, etc. and draft thoughtful answers ahead of time. Ask the site for their top questions in advance and bucket them (medical/eligibility, IP/logistics, data/systems, scheduling). Align on responses with the Sponsor so you avoid surprises during the visit.
Tailor the visit to the site:
Adapt your script to local workflows and risks, for example lab processes, pharmacy hours, courier cut-offs, etc. Site staff engage more when content reflects their reality and has been put together with their specific needs in mind, as opposed to a copy-paste script from prior SIVs. Call out site-specific nuances and highlight how the study team will support them.
Run a dry Site Initiation Visit with the Sponsor beforehand:
Schedule a full run-through with the Sponsor and the cross-functional team. Confirm who covers what, align on the points to stress, and rehearse tricky areas. Test system demos, links, and timings so there are no surprises in the live meeting. Use the rehearsal to lock ownership of tough questions and the escalation path.
Close with a readiness checklist and 48-hour follow-up:
End the SIV by reviewing an action log (owner, due date, status) and a first-patient readiness checklist (delegation log, training records, IP release, Electronic Data Capture (EDC) access, safety contacts, kit/labels, lab kits/supplies). Within 48 hours, send a concise follow-up pack: Follow-Up letter, action letters contact tree, system job aids and red-flag reminders (visit windows, reporting timelines). This keeps momentum and prevents drift.
How Can WEP Support Your Site Initiation Visits
WEP Clinical helps Sponsors and sites move from SIV to first-patient-in faster, without cutting corners. By ensuring SIVs are structured, thorough, and aligned with site needs, we reduce start-up delays, prevent common pitfalls, and build site confidence from day one.
If you would like to learn more about our Expanded Access Services, click here.
