Setting up a teletrial

The steps below will guide you through setting up a teletrial, starting with how to determine if your trial is suitable.

Use the Primary Site Workflow and the Satellite Site Workflow checklists and the QRCCC Workflow on the Australian Teletrial Program website. These will guide you through the process. You’ll need to work with both the Queensland Regional Clinical Trial Coordinating Unit (QRCCC) and each satellite site to complete the checklists.

You can add more satellite sites after you've set up your teletrial. You can do this at any time, as long as your sponsor and the primary site agree.

Step 1. Evaluate the trial

You’ll need to see if your trial is suitable for a teletrial. Use the Evaluation of a Clinical Trial as a Teletrial Checklist on the Australian Teletrial Program website.

If you have a confirmed protocol, you can do your evaluation and the site feasibility at the same time. You can also do it if you’re introducing satellite sites, with identified potential participants, into an existing clinical trial.

Step 2. Get agreement from your sponsor

If your trial looks like it’s suitable, you’ll also need to get agreement from your sponsor.

You can submit your evaluation of a clinical trial checklist to your sponsor as part of the approval process.

Step 3. Inform your Human Research Ethics Committee (HREC)

If your trial has already been approved by an HREC, submit an amendment to the HREC so your trial can be approved as a teletrial. Use the Notification to reviewing HREC of satellite site joining a teletrial checklist (DOCX 526 kB).

Make sure you include updates to the Master Stand Alone Teletrial Participant Information Sheet and Consent Form (PICF) on the Australian Teletrial Program website. You'll also need to include the teletrials specific wording.

If your trial hasn’t been approved by the HREC, make sure you let them know your sponsor has agreed to a teletrial. You’ll also need to add the teletrials specific wording to the Master PICF.

Step 4. Primary Sites

The Principal Investigator must agree to taking on the additional responsibilities involved in running a teletrial.

Step 5. Identify and evaluate satellite sites

Identify potential sites to see if they’re suitable to be used as satellite sites. Use the Evaluation of a Site as a Satellite Site Checklist on the Australian Teletrial Program website.

Your sponsor must also agree to the satellite site’s involvement.

Step 6. Prepare a supervision plan

Work with your primary site to develop supervision plans for each satellite site. These should be done according to the level of clinical trials experience and clinician expertise at each satellite site.

Make sure you include satellite sites in the CTN Form if drugs are going to be stored at the site. The principal investigator at the primary site should also be listed as the principal investigator at each satellite site. The associate investigator at a satellite site isn’t the principal investigator.

Read the National Standard Operating Procedures for Clinical Trials including Teletrials for more information and make sure each site is familiar with them.

Step 7. Prepare contracts

Prepare the teletrials subcontract between the primary site and each of its satellite sites.

Step 8. Get governance authorisation

Make sure your primary site and each satellite site has governance authorisation.

The following check lists have a list of the documents you need to include when you apply for governance authorisation:

• Primary site RGO submission document (DOCX 529 kB)
• Satellite site RGO submission document (DOCX 529 kB)

Insurance and indemnity

All sites must have their own insurance. If indemnity is provided by the sponsor to the primary site, it must also include all satellite sites.

If indemnity isn’t provided by the sponsor, each site including satellite sites must have their own.