Local site approval

Local site approval, also known as the Site Specific Assessment (SSA) process, is the final step in setting up your trial. This approval is separate from but often dependent upon the approval granted by the Human Research Ethics Committee (HREC). The SSA process involves the submission of all documentation as per the ethics application; however, documents such as the participant information sheet and consent form may be adapted to include the local site’s logo and information. Research agreements are also to be submitted with the SSA application. Interventional clinical trials will generally use one of the Medicine’s Australia Research Agreements.

The documentation is submitted along with the HREC approval. The site reviews the documentation assessing whether finance is in place and relevant risks related to the trial have been identified and appropriately managed ensuring the study is conducted in a manner that is scientifically rigorous and ethically sound.

Preparation

• Contact your local Governance Office or University legal team for advice and guidance on project governance and contracting. If utilising public hospitals a SSA application will have to be submitted to each site involved in the study.
• Gather all information and documentation, and where applicable, ensure the local site's logo and information are on documents such as the participant information sheet and consent form.
• Ensure the following are fully executed (where applicable):
  • funding agreements
  • research agreements (ensure intellectual property is appropriately attributed)
  • authorship agreements
  • service agreements
  • student confidentiality forms
  • manufacturers and financial disclosures
  • office of the Gene Technology Regulator and institutional biosafety (GMOs)
  • indemnity 
  • insurance.
• If your trial is using the tele-trial model, the following additional information will be required:
  • standard CTRA tele-trial sub-contract
  • supervision plan.

Complete the application

• Where local site approval is required access the SSA through your local State or Territories portal.
• Complete each section of the application thoroughly and accurately.
• Obtain signatures. 
• Attach all supporting documents.

Review and submit

• Review the application for completeness and accuracy. Ask a colleague to check the application.
• Submit the application through the online portal.