FAQ: Multi-centre research (roles and responsibilities)
What is the role of the co-ordinating investigator?What is the role of the local principal investigator?
What is the role of the HREC Executive Officer?
What is the role of the Research Governance Officer?
Does the co-ordinating investigator have to reside within NSW?
Who reviews the Participant Information Sheet and Informed Consent document/s?
Who signs the CTN form and when does this happen?
Who is responsible for monitoring multi-centre research projects?
Is the local principal investigator required to submit annual reports to the lead HREC that approved the project?
Who is responsible for reviewing reports of adverse events?
Is the lead HREC responsible for scientific/technical assessment of the research project?
Where can I get more information/advice?
What is the role of the co-ordinating investigator?
The co-ordinating investigator is the person responsible for the overall coordination of a multi-centre research project. The lead HREC communicates only with the co-ordinating investigator in relation to HREC applications. The exact role of a co-ordinating investigator for a specific study is a matter for each individual research team, however this role typically includes:
- determining a preferred lead HREC and contacting the HREC to check agenda availability;
- submitting an application for ethical review to the lead HREC;
- communicating with the lead HREC in relation to the application; and
- distributing HREC documentation to local principal investigators (where applicable).
What is the role of the local principal investigator?
The local principal investigator is the person responsible for the conduct of the research project at an individual study site. This includes:
- submitting the SSA form to the Research Governance Officer;
- communicating with the Research Governance Officer in relation to the SSA; and
- liaising with the co-ordinating investigator of the study (where applicable).
What is the role of the HREC Executive Officer?
Each HREC has an Executive Officer, who provides executive support to the HREC and liaises with co-ordinating investigators regarding research proposals submitted to the HREC for review.
What is the role of the Research Governance Officer?
The Research Governance Officer is the person within the public health organisation responsible for reviewing the SSA Form and making a recommendation to the Chief Executive or their delegate, as to whether or not the research project should be granted authorisation to proceed at the site. The Research Governance Officer may or may not also be the HREC Executive Officer.
What is the role of the NSW Health Shared Scientific Assessment Committee (SSAC)?
The SSAC is available to review multi-centre and single-site clinical drug trials in circumstances where a NSW Health HREC is unable to meet the provisions under the NSW Health Policy Directive 'Standards for Scientific Review of Clinical Trials'. Lead HRECs are expected to obtain timely scientific reviews without regular reliance on the SSAC, however they may utilise the SSAC for unusually complex research or occasional first-time-in-human and first-time-in-patient clinical trials. Further information on the role of the SSAC is available at: