The Principal Investigator at each site is responsible for ensuring that reporting requirements are adhered to.
The Clinical Trial Research Agreement (CTRA) will specify any reporting obligations by the site to the Sponsor.
The approving Human Research Ethics Committee will also require an annual progress (milestone) report to be submitted. In NSW this is via the REGIS portal.
It is important to ensure that communications with your site participants are carried out according to the communications plan particularly sharing research outcomes. See here
Your Research Office requires Governance Milestones to be reported via REGIS.
The NSW OHMR has prepared information on the role and responsibilities of organisations, institutions, investigators and sponsors who are engaged in clinical trials.
