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.

Who can help?

• Calvary Mater Newcastle Research Office

• Central Coast Local Health District Research Office
• Hunter New England Local Health District Research Office 
• Mid North Coast Research and Knowledge Translation Unit
• University of Newcastle Research Office
• University of New England Research Office
• HMRI Clinical Trials Unit