Post-approval and monitoring

Amendments (including changes to members of the research team)

• Changes to Research Team Members

  Please complete the Amendment Request Form for any changes to the research team.  If you are adding a new team member, you also need to submit the Addition of a Research Team Member form.

  If members of research teams require an Eye and Ear Honorary Researcher Appointment, please refer to the Honorary Researcher Appointment webpage.

• Eye and Ear site specific research governance

  If the amendment requires approval from the Reviewing HREC, submit the request for amendment to the Reviewing HREC (according to their instructions) first. Once the amendment is approved, submit a request for amendment to the Eye and Ear Research Office using the Site Governance Amendment Request Form on ERM.

  The Site Governance Amendment Request form can be used to notify the Research Office of either:

  • an amendment that has been approved by the reviewing ethics committee
  • a site specific governance-only amendment that does not require ethical approval (e.g., change of research team or site specific PICF).

  Submission instructions:

  • Amendments can be submitted at any time as follows:
    – Eye and Ear site specific research governance – all post authorisation project management must be submitted via ERM using SSA notification forms.

• Annual Progress Report

  Submit a copy at least annually by the date of approval of:

  • Reviewing HREC Progress Report, with acknowledgement
  • Progress Report – Site Form (via ERM)
• Annual Safety Reports for Clinical Trials

  Submit at least annually by the date of approval of:

  • Annual Safety Report
• Final Report

  Submit a Final Report at the completion of the study or if discontinued early.

  • Reviewing HREC Progress Report

  Submission instructions:

  Submit the relevant Report as directed as follows:

  • Eye and Ear site specific research governance – all progress reports must be submitted via ERM using SSA notification forms.