Clinical Trials

Research is an essential part of the health care system that allows for the discovery and development of new and innovative treatments. Clinical trials, research registries and biobanks are types of research that facilitate the development of new treatments, procedures and therapies used to prevent, detect, treat or manage diseases and medical conditions.

Before any research can be conducted on human beings or using their data or biological samples, the proposed project must undergo an approval process. These processes are known as ethics and governance.

Governance Approval Process

Clinical trials, registries and biobanks must seek in principle support from the Clinical Trials Committee (CTC) prior to submitting for ethical approval or, in the case of NMA exempted studies, site specific governance approval. To learn more about the CTC including the terms of reference, click here.

For the purposes of the CTC a clinical trial is described as:

“Clinical research where a therapeutic intervention in human subjects is being evaluated”

The purpose of the CTC is to review and authorise clinical trials or registries conducted which involve ACT Health resources.  The CTC operates a two-step process: a feasibility assessment, followed by in principle support.

Step 1: Initial Feasibility Review

The following items are to be submitted for initial feasibility review:

Please submit all items above to research.governance@act.gov.au

Step 2: In principle support

Step 2 of the process includes proceeding with budget negotiations and ethics/site governance review.

Budget negotiations must be conducted with the Finance Officer and, once approved, submitted with a signed finance summary – provided by the Finance Officer.

Once budget negotiations are final, submit the final research agreement and financial summary for review and authorisation to research.governance@act.gov.au

Go to the Human Ethics and Site Governance section to start the ethics/site governance review process.

For any queries please contact the committee secretariat on 02 5124 7968.

Page last updated on: 13 Nov 2018