I have a Sponsor and funding for my trial

If you have been asked by an industry Sponsor, a commercial company or a cooperative trials group to participate as an Investigator on their trial, this Roadmap is for you.

The Roadmap is intended to offer practical support and guidance on development, resourcing, ethics and governance required for your clinical trial in a complex research environment.

The Clinical Trials Roadmap sets out key steps, highlights organisational services with whom it is advisable to engage, and who is available to assist you during the process of agreeing to and participating in a clinical trial if it will be conducted at any of the following sites:

  • your local health district
  • your hospital or health service
  • your department
  • your university, your department, school or discipline
  • the Hunter Medical Research Institute

Contacting and consulting with the appropriate services will help you to establish your trial successfully and as quickly as possible.

Equitable access to clinical trials for patients in NSW is a priority and is an important consideration for investigators when deciding to participate in a clinical trial. By including patients in rural, regional and remote areas of the community you may improve health outcomes and increase life expectancy.

Early collaboration with clinicians and clinical units across your community should be considered as an important mechanism to improve access to clinical trials. The idea of ‘teletrials’ is of increasing interest for clinical trials. Information about teletrial conduct can be found in the following section: ‘Feasibility Assessment’.

Note: Your public health organisation’s Research Office must ensure all relevant approvals are in place before a research project can take place within their organisation. The Research Office needs to be aware of all projects that involve their organisations staff, resources and access to participants, tissue and data. Please contact the relevant research office in the early stages of negotiation so that they can help identify services that can provide you with valuable support and all governance requirements are met.

Before you begin you will require Good Clinical Practice (GCP) certification. GCP certification is an internationally accepted standard for people working on the design, conduct, recording and reporting of clinical trials. It ensures staff conducting clinical trials are working to international best practice. Information about GCP certification can be found here and GCP Providers are listed here


Investigator Initiated Trials


Confidentiality and Feasibility