Researcher Responsibilities

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?


Post Site Activation



Further reading