Following site activation, it is important for researchers to maintain the highest standards in the conduct of their research and to ensure that the trial is delivered by adhering to:

• Any laws and legislation as they pertain to the conduct of your clinical trial
• The protocol
• Any conditions specified in the ethics approval and site authorisation
• The terms of the Sponsors agreement
• The terms and conditions of any funding agreement

Researcher Responsibilities

Reporting requirements should be adhered to.

• The Clinical Trial Research Agreement (CTRA) will specify any reporting obligations by the site to the Sponsor.
• The Human Research 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 is outside of REGIS and is being managed in another jurisdiction, the HREC approved annual progress reports must be submitted to the sites
• 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