The Coordinating Principal Investigator is responsible for ensuring that reporting requirements are adhered to.

• 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.

• The HREC who gave ethics approval will require an annual progress report. For HRECs within NSW Health, these are submitted via the REGIS portal.
• Information about safety notifications and reporting pathways for therapeutic and non-therapeutic goods trials can be found on the OHMR and the NHMRC website.
• You will need to follow your Participant Communications Plan, in particular sharing the trial results in a lay summary.

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