Clinical drug studies

What is a clinical trial?

A clinical trial is a research study designed to assess the safety and/or effectiveness of a therapeutic intervention, including new drugs, devices and diagnostic tools.

In trials regulated by Australia’s Therapeutic Goods Administration (TGA), “research” refers to the use of an unapproved therapeutic product. This includes any therapeutic product that is:

• Not included in the Australian Register of Therapeutic Goods (ARTG), or
• Is included in the ARTG but is being used in any way that differs from the approved use (e.g different therapeutic area, route of administration, formulation)

Two regulatory pathways for clinical trials

Medicines administered pharmacologically, such as drugs, cell therapies, biological products, vaccines and radiopharmaceuticals, are reviewed under the TGA’s Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) Schemes.

For researchers running clinical trials, determining which category applies to your product is the first step before submitting a study for ethical review.

Bellberry is uniquely positioned to review complex and innovative research, with each HREC tailored to the specific studies under review and supported by a membership pool with expertise across a broad range of therapeutic areas, including first-in-human and cell and gene therapy studies.

The depth and breadth of expertise available across our HRECs means most applications submitted to Bellberry are generally accepted under the CTN pathway, unless the CTA pathway is mandated by the TGA requirements.

What Bellberry’s ethics committees can review

Bellberry’s Human Research Ethics Committees (HRECs) review clinical drug trials across all phases — from First In Human studies through to post-marketing surveillance — conducted under the TGA’s Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) Schemes.

Our HRECs bring together leading scientific, medical, legal and community expertise, tailored to suit the type and phase of your study.

With weekly meetings and a typical turnaround of around 21 working days, Bellberry offers one of the most efficient and rigorous review processes in Australia.

Bellberry ethics approval is widely accepted across the private sector. In the public sector, acceptance of Bellberry ethics approval is determined at the discretion of the relevant health service or jurisdiction and may vary by study phase. If you are considering a submission for a public health site, please see Public Health Site submissions.

For more on our committee structure, expertise and accreditation, see Human Research Ethics Committees.

Drug trial monitoring requirements

The NHMRC sets out the requirements for monitoring and reporting of safety events and serious breaches for clinical trials conducted in Australia.

• Safety events — see NHMRC Safety Monitoring and Reporting in Clinical Trials (2016) and Bellberry’s Safety Reporting guidance.
• Serious breaches — see Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods and Bellberry’s Serious Breaches guidance.

How to submit your drug trial for review

Clinical drug trial applications are submitted through Bellberry’s eProtocol online system.

See How to Apply for step-by-step guidance on registration, documentation requirements and the submission process.

Further guidance

• Australian Clinical Trial Handbook
• National Statement on Ethical Conduct in Human Research (2025)
• NHMRC Safety Monitoring and Reporting in Clinical Trials (2016)
• Data Safety Monitoring Boards (2018)
• Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods
• ICH GCP Guidelines
• Therapeutic Goods Act 1989
• Therapeutic Goods Regulations 1990