6. Governance and Ethics

The ethics submission process for a telehealth trial is similar to that of a traditional trial but requires a few additions. There are many roles who need to come together to ensure the timely and successful submission of HREC and RGO submission for a teletrial. These include the Primary Site HREC, Primary Site RGO and the Satellite Site RGO. This page outlines a step-to-step guide through the HREC and RGO submission process.

HREC Submission Process

Prior to HREC submission, the investigator must do the following:

  • Choose a relevant reviewing HREC, and
  • Review the necessary requirements and deadlines to ensure documents are submitted on time.

Ensure all teletrial-specific documents are prepared before submission along with the documents needed for a traditional trial.

Use this HREC submission teletrial documents checklist to ensure all required teletrial-specific documents are included:

  • Agreement from the Sponsor to allow teletrial inclusion
  • Inclusion in the ethics section that the trial may be undertaken using telehealth with Satellite Sites
  • Copy of the CTN listing the Satellite Sites
  • Information about how the patient data will be securely shared between sites
  • Participant Information Sheets including optional teletrial-specific wording
  • If relevant, separate teletrial specific PICFs
  • Sponsor agreed process by which consent will be obtained at Satellite Sites
  • CV and GCPs for Investigators at each Satellite Site
  • Draft or unsigned copy of supervision plan
  • HREC’s Form of Indemnity (updated to include Satellite Sites)
  • If required, radiation assessment report.

Submit the ethics application through the relevant reviewing HREC submission process.

  • Be clear in the submission package that this is a teletrial study.
  • Ensure that each Satellite Site is not a participating site in their own right but are supervised by the Primary Site.
  • Request that the approval letter outlines this set up.

Ensure all documentation and correspondence from the submission and approval is filed in the Site Master File.

HREC must be notified of any changes after HREC submission such as changing a standard approved clinical trial to a teletrial or adding additional Satellite Sites to an approved cluster already using the teletrial model. An amendment may be needed.

Ethics Submission Map

The Primary Site takes responsibility for all reporting to the CPI on behalf of the satellite sites. This includes ongoing reporting to HREC, annual reports and safety reports.

RGO Submission Process

Primary Site Teletrial Documents checklist for PS RGO Submission:

  • Cover Letter from Primary Site PI
  • Participant Information Sheets and Consent Forms (with teletrial specific wording)
  • CTRA amendment that includes Satellite Sites
  • Subcontract agreements between Primary Site and Satellite Sites
  • Signed Supervision Plan between Primary Site and Satellite Sites
  • Indemnity or insurance cover documented for Satellite Sites.

Satellite Site Teletrial Documents checklist for SS RGO:

  • Cover letter from Satellite Site PI, including:
    • A statement “The study is to be conducted under the teletrial model with [enter PS name] as the Primary Site and [insert site] as the Satellite Sites
    • List of documents uploaded to ERM for PS RGO review
  • Site-specific Assessment (SSA)
  • PS RGO authorisation
  • Cluster participant
  • Subcontract agreement between PS and SS
    Budget signed by SS finance officer
  • Signed supervision plan between PS and SS
  • CTRA amendment to add SS
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