5. Contracts and Budgets

The Teletrial Budget

The Sponsor undertakes budget negotiations with the Primary Site (PS) in the routine manner. In preparing for these negotiations, a budget for all PS and Satellite site (SS) costs must be created. The PS then distributes these funds to the SS as documented in the subcontract.

What to consider when budgeting for a teletrial:

• It’s important to consider what the Primary Site will need to assist the Satellite Site in the initial start up and with the ongoing trial activities.
• Some additional costs to consider when creating a budget for a Teletrial include:
• Reimbursement for costs if the Primary Site is sending and retrieving Investigational products or supplies to the Satellite Site.
• Satellite Site pharmacy fees if IMP will be delivered, stored and dispensed at Satellite Site.
• Costs associated with use of telehealth services.
• Outsourcing of clinical trial related assessments that may not be available at Satellite Site.
• HREC and RGO fees.
• Start up and close up fees, amendment fees and fees associated with the Primary Site’s administration of the Satellite Site.
• Costs associated with data entry on behalf of Satellite Site.

View the teletrial fees and guidelines document from Alfred TrialHub for a summary of costs.

Clinical Trial Research Agreements (CTRA)

The Clinical Trials Research Agreement (CTRA), known as the Head Agreement in teletrials, is the main contract between the Sponsor and the Primary Site (the ‘Institution’) employing the Principal Investigator. 

Medicines Australia CTRA Templates

The Teletrials subcontract

The teletrial subcontract is an agreement between the Primary Site and Satellite site and is designed to complement the CTRA and formalise the relationship between the Primary Site and Satellite Sites.

Broadly the subcontract states that the Satellite site agrees to perform the study in accordance with the trial protocol, supervision plan, GCP and applicable laws, legislation, and approvals.

The requirement for a subcontract in teletrials differentiates it from the way trials are traditionally conducted.

Medicines Australia Subcontract Template

Clinical Trial Notification Scheme (CTN)

The Importation into and/or supply in Australia of ‘unapproved’ therapeutic goods for use in Australia are controlled by the processes of the Clinical Trial Notification scheme (CTN) and the Clinical Trial Approval (CTA) Scheme.

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.

A Satellite Site does not need to be listed on the CTN form when unregistered goods or IMP are only being shipped to the Satellite Site site on a visit-to-visit basis.

Indemnity

The sponsor is responsible by law and liable for the trial protocol. They are required to maintain insurance throughout the trial period for all sites conducting trial activities in case of loss or harm occurring to the sites or participants caused by the trial. This includes the Satellite Site as well as the Primary Site.

If an external service is used (i.e. a courier service for IMP delivery), the service will not be covered by the Sponsors Indemnity. Sites and service provides should enter a Service Level Agreement and providers must provide their own indemnity.

Medicines Australia Indemnity Compensation Guidelines