7. Site initiation

This page provides an overview of the documents and processes to assist sites with a teletrial Site Initiation Visit (SIV).

SIV preparation

Regular communication between the Sponsor, Primary Site and Satellite Site is essential to ensure a successful teletrial SIV. 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

The Site Initiation Visit

The documents and processes required in a teletrial SIV do not differ significantly from a traditional clinical trial but it is important to remember that CVs, contact details and other site personnel essential documents are required from all Satellite Site staff that the PI has responsibility for.

The following are key issues that should be addressed at the SIV:

  1. Investigational Product including the delivery and receipt of Investigational Product and other supplied to sites.
  2. Pharmacy and defining any activity linked to the Investigational Medicinal Product
  3. Laboratory manual including contact list for all laboratories involved.
  4. Equipment including any specilised equipment required.
  5. Case Report Forms including completion guidelines and accessibility across sites.
  6. Training in all aspects of the Protocol.
  7. Achieving requirements of all study records at the end of the study.
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