5. Contracts and Budgets
The Teletrial Budget
Budget considerations are undertaken in a routine manner with the Primary Site (PS). Costs associated with the Satellite sites are included in this budget and are to be included in the Clinical Trial Research Agreement (CTRA) alongside the Primary Site costs. The Primary Site is then responsible for distributing funds to the Satellite Site as documented in the Subcontract.
Additional fees involved with teletrials include costs associated with establishing and maintaining the Satellite Sites, and costs associated with running trial activities at the Satellite Site.
It’s encouraged to approach teletrial budgets with flexibility to understand the requirements of sites using this model.
Clinical Trial Research Agreement (CTRA)
The Clinical Trial Research Agreement is still required between the Sponsor and the Primary Site with small changes to reflect the Satellite Site’s involvement. A contract is not needed between the Sponsor and the Satellite Site.
- Satellite Sites should be named in Schedule 1 as participating sites in the cluster and their addresses should be included.
- Agreed updates to the study budget for the Primary Site to accommodate Satellite Site inclusion should be noted in Schedule 2. Teletrial-related payments from the budget should be included.
- When new Satellite Sites join the cluster, the CTRA should amend Schedules 1 and 2 as above.
The teletrial subcontract is an agreement between the Primary Site and Satellite Site and is designed to formalise the relationship between the two. It is the Primary Site's responsibility to negotiate the subcontract with each Satellite Site.
Clinical Trial Notification Scheme
As with any other clinical trial, all Primary Sites will be listed on the Clinical Trial Notification (CTN). A Satellite Site is listed on the initial CTN submission when:
- When IMP or unregistered equipment is being stored at the Satellite Site, and/or
- Pathology Kits containing unregistered therapeutic goods are being stored at the Satellite Site.
Sponsors are required to maintain insurance throughout the trial period for all sites conducting trial activities. This includes Satellite Sites.