This page provides an overview of the documents and processes to assist sites with a teletrial Site Initiation Visit (SIV).
The SIV is a meeting where the Sponsor discusses the protocol and provides training to the staff on study related processes. At this visit, the Sponsor confirms the site’s readiness to commence the trial and identifies any requirements that need to be met prior to site activation.
Preparing for the SIV
Regular communication between the Sponsor, Primary Site and Satellite Site is essential to ensure a successful teletrial SIV. Start-up meetings should be also organised between the Primary Site and Secondary Site (SS) prior to the SIV to discuss SS needs, budgets and keep track of documents. To aid with these discussions, use an agenda and discussion template with a document tracker. The below Agenda and Discussion Record for Satellite Site Start-uP by AlfredHealth TrialHub can be used as a template to assist with the start-up and track any pre-SIV meetings.
AlfredHealth TrialHub Agenda and Discussion Record for Satellite Site Start-Up
Preparation Checklist
Before the SIV, ensure all sites are well prepared. Use the following checklist to help prepare for the meeting.
- A suitable agenda
- Ensure all attendees have read the protocol and understand the trial activities
- Compile a list of questions or points that need clarification. Consider asking about the following:
- Method of action of Investigational product (IP)
- Main side effects of the IP
- Inclusion and Exclusion criteria
- Adverse Events of Special Interest
- Any special tests or equipment that require additional time, resources, coordination or outsourcing
- Case report form completion guidelines
- Training required for staff
- Drug administration or dosing changes
- Reviewing any errors that have arose at other teletrial sites and how they can be addressed
- Commonly missed tests or known pitfalls
- Central lab kit management
- Specific storage conditions for the IP
- Shipping conditions for the IP
- What courier to use for the IP
- Archiving requirements at the end of the study
The following documents need to be organised and available to Sites on the day of the SIV:
- Study Master File with all required Essential documents
- Attendance log of all staff attending SIV and method attended (i.e. in person or online)
- CVs of all study personnel involved in trial (including SS) – must be original, signed and dated
- Contact list – names and contact details of all staff from all sites
- Site Personnel Essential Documents – financial disclosures, medical licences etc.
