Site Initiation Visit (SIV) Scheduling and the SIV Letter: What You Need to Know

Kelly Breuer
Jun 29
2 min read

The Site Initiation Visit (SIV) is a critical milestone in the site start-up process. This formal “go-live” meeting between the Sponsor and the site ensures that all critical site staff are trained, the trial materials are in place, and everyone is aligned on the protocol interpretation, regulatory expectations, and logistics.

Before the visit happens, there’s a lot of coordination behind the scenes. Here’s what goes into SIV scheduling and what you’ll typically find in the lead-up to the SIV.

SIV Scheduling: Balancing Readiness with Urgency

Scheduling an SIV is more than just finding a date that works for everyone- it’s an alignment of readiness and compliance:

Essential Documents: Requirements for scheduling the SIV will vary from site-to-site, and it's good to ask early on what documents need to be completed and what documents can be in progress to schedule the SIV. Generally, the required documents will include IRB/EC approval, a fully executed clinical trial agreement, and essential regulatory documents (examples include the Investigator Agreement and Financial Disclosure Forms) have been collected. One common exception to this is the CTA may be fully agreed upon but not yet signed.
Study Supplies & Systems: Demonstration devices (if applicable), lab kits, and other study materials should be delivered ahead of the SIV (make sure the site knows to bring them!) or brought to the SIV.
Availability of Key Staff: Critical staff must be at the SIV- generally this is the Principal Investigator (PI) and a study coordinator but may also include an imaging specialist if required by the protocol. Any proposed sub-investigators or coordinators should be available to attend the training, but their training can be completed after activation.

Proactive communication with the site is key, often involving multiple back-and-forth emails or calls to align on a mutually agreeable time, while navigating investigator availability and sponsor timelines.

The SIV Letter

Once the visit is scheduled, a formal SIV confirmation letter is sent. This letter serves as both a meeting invite and checklist. Here's what it usually includes:

1. Meeting Details

Date and time of the SIV (inclu
ding time zone)
Type of Meeting (on-site or virtual, including the video/conference link for remote SIV)
If on-site the room number/location for the meeting
Attendees expected from both sponsor/CRO and site

2. Objectives of the Visit

Review of the protocol, inclusion/exclusion criteria
Study procedures, visit schedule, and documentation expectations
Safety reporting, informed consent process, and GCP compliance

3. Study Tools and Training

Overview of training to be completed during the SIV (e.g., EDC, Protocol, ePRO, Device, lab manual)

4. Documents that need to be collected

Overview of essential documents that are needed for activation

5. Contact Information

A point-of-contact from the sponsor or CRO for any last-minute questions or technical issues

Final Thoughts

The SIV sets the tone for site engagement and trial conduct. A well-organized SIV process and clear, detailed confirmation letter ensure that everyone shows up informed and prepared. Clinical teams that invest time in smooth scheduling and communication reduce activation delays and build strong site relationships from Day 1.