Reporting requirements should be adhered to.

  • The Clinical Trial Research Agreement (CTRA) will specify any reporting obligations by the site to the Sponsor. 
  • If you are the Coordinating Principal Investigator the Ethics Committee will also require an annual progress (milestone) report to be submitted via the REGIS portal.
  • Your Research Office requires Governance Milestones to be reported via REGIS. The milestones include:
    • First Patient In data is collected for the NSW Health metrics.
    • Certificate of currency renewals must be provided and evidence current professional indemnity and products liability policy(s), or equivalent, and must include clinical trials cover
    •  Progress Report – External HREC: Where Ethics approval is granted by a HREC in another jurisdiction, the HREC approved annual progress reports must be provided.
  • Information about safety notifications and reporting pathways for therapeutic and non-therapeutic goods trials can be found on the OHMR and the NHMRC website.


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