Site Specific Assessment

How to apply to the Eye and Ear for Site Specific Assessment authorisation?

• Cover Sheet for Research Project

  Download the Eye and Ear Cover Sheet for Research Project and any attachments required (as detailed within the cover sheet).

  The Cover Sheet for Research Project collects information specific to the Eye and Ear which is not included in the Application Form or other documents.

  Do not submit a separate cover letter.  There is room in the Cover Sheet to include other relevant information for the project.

• Human Research Ethics Committee Approval Letter

  Submit the Human Research Ethics Committee approval letter.

  The letter must list The Royal Victorian Eye and Ear Hospital as a research site.

• SSA Form

  Complete the Site Specific Assessment (SSA) Form on Ethics Review Manager (ERM) platform.

• Protocol

  The version of the Protocol approved in the Reviewing HREC letter of ethical approval (or amendment approval) must be uploaded into ERM in section ‘Supporting Documents’.

  A detailed protocol including but not limited to:

  • Statistical analysis plan and safety and data management plan as appropriate
  • Copies of all data collection instruments.
• Investigator Brochure

  Any Investigator Brochure or equivalent approved in the Reviewing HREC letter of ethical approval (or amendment approval) must be uploaded into ERM in section ‘Supporting Documents’.

• Victorian Specific Module

  The Eye and Ear Hospital only requires the Victorian Specific Module (VSM) to be submitted if the Reviewing HREC is not in Victoria. Complete the Victorian Specific Module on the Ethical Review Manager platform.

• Participant Information and Consent Forms

  Applicants will need to submit the Master Participant Information and Consent Form(s) or equivalent that have been approved by the Reviewing HREC.

  Applicants will also need to submit the Eye and Ear site specific Participant Information and Consent Form(s) which are based on the approved Master PICF(s) and amended as per Eye and Ear site specific requirements.

  Please refer to the Participant Information and Consent Form Section of this website.

• Research Agreements

  Where the research project involves another organisation, a formal research agreement should be executed between the parties.

  This includes:

  • commercially sponsored research
  • research with a collaborative group
  • collaborative research with another Australian or international organisation

  Further information regarding research agreements is available here.

• Insurance and Indemnity

  For studies conducted by a third party, the third party is requested to indemnify the hospital and provide a current certificate of insurance.

• Certificate of Insurance

  For research projects involving a sponsor or third-party organisation, please provide a current Certificate of Insurance.

  Detailed information regarding insurance and indemnity is available here.

• Clinical Trials and TGA requirements

  Any clinical trial involving the use of unapproved therapeutic goods must provide acknowledgement of either TGA Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) listing the Eye and Ear as a clinical trial site.

  Detailed information regarding Clinical Trials and TGA requirements are available via the TGA website.

• Head of Supporting Department Declarations

  Research teams proposing to conduct a research project that utilises Eye and Ear departments must consult with the Head of the department and obtain a signed Head of Supporting Department Declaration Form to submit with the application form.

  Details for each of the supporting departments are available in the Involvement of Eye and Ear Hospital departments in research projects.

• Members of the research team and signatures

  Principal Investigator – A copy of a Curriculum Vitae (CV), professional registration and GCP certificate for the Principal Investigator should be uploaded to ERM as part of the submission.

  Members of the Research team – CVs for research team members are to be submitted, if they have not been submitted to the Research Office within the last two years. For clinical trials also submit current GCP certificates for all research team members. All members of the research team must be listed as part of the ‘Project Team’ and all members of the research team must sign the application. Please ensure that the Investigator Team Declaration is completed by all team members. These signatures can be provided in a number of ways (electronically within the application form or upload evidence of signature as a separate document). Please read the instructions carefully in the application form relating to electronic signatures and locking of the form. Also refer below for more guidance on signatures. All staff who have patient contact and / or are consenting patients / participants must be listed as part of the ‘Project Team’ on the application form as either Investigator/Researcher or Other and then specify the role.

  The following types of signatures are accepted by the Eye and Ear:

  1. Ink signature on hard copy document
  2. Scanned version of ink signature on hard copy document – research team must retain original hard copy ink signature
  3. Electronic signatures – DocuSign

  ERM Signatures and Submission Guidance is also available on the website. This guide provides step by step instructions for signatories and those submitting an application form.

• Submission Dates

  Applications can be submitted to the Research Office at any time.

  Submit your application online via the Ethical Review Manager platform.

  Applications will be reviewed and applicants will receive an initial response within 14 working days from the date of submission.

  Minimum standards apply to all applications:

  • Applications must be complete; incomplete applications will be returned to the researcher
  • Handwritten applications will not be accepted
  • Principal Investigators must sign all correspondence