Clinical Trials

Background

NT Health Clinical Trials Unit (NTCTCU)?

The NTCTCU consolidates and expands existing functions to establish a central point of contact for clinical trial sponsors, researchers, coordinators and participants, and provide a single point of application for research ethics and site specific approvals at TEHS.

The NTCTCU provides a centralised source of advice and is facilitating the introduction of standard operating procedures across all Central Australia Health Service (CAHS) Department of Health (DoH) and Top End Health Service (TEHS) sites.

It will draw upon strong Indigenous leadership across the Northern Territory, to support and encourage best practice and culturally appropriate research and recruitment, including for vulnerable populations.

The NTCTCU also provides a first point of contact for collaborative research proposals.

All collaborative research projects require authorisation from the relevant Chief Operating Officer (COO) or the Chief Executive, NT Health.  The NTCTCU will provide assistance with the authorisation process.  Contact clinical.trials@nt.gov.au for further information.

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What is the governance process for undertaking clinical trials at NT Health sites?

The first point of contact is general through discussion with relevant clinical experts or active clinician researchers.

The relevant Research Governance Office will assist clinical trial sponsors or lead investigators of investigator led multi-centre trials who are unfamiliar with the Northern Territory to identify and contact appropriate collaborators.

Once participation in a trial has been scoped out with local collaborators, the standard Research Governance and Human Research Ethics Committee (HREC) endorsement, authorisation and approval processes apply.

HREC and Governance submissions can occur simultaneously.

What forms do I need to complete?

For Primary Health Care sites, researchers are required to submit the following forms to the relevant research governance office rgo.tehs@nt.gov.au:

OR

For all other sites, researchers are required to submit to the relevant research governance office rgo.tehs@nt.gov.au

  • a completed relevant HREC form
  • a completed NT Health Research Resources form

AND

For all research that requires data release from DoH centralised collections, researchers are required to submit an application through the data access process

Does the Northern Territory have any specific requirements relating to Aboriginal and Torres Strait Islander people participating in clinical trials?

The Northern Territory has some specific requirements to review of projects explicitly involving Aboriginal and/or Torres Strait Islander people under the HREC National Mutual Acceptance Memorandum of Understanding.

This involves responding to the 6 core values of Reciprocity, Respect, Equality, Responsibility, Survival and Protection, Spirit and Integrity with reference to how this project will be of benefit to or, have an impact on Aboriginal and/or Torres Strait Islander Peoples and their communities.

Guidance for responding to these values can be found in the NHMRC publication ‘Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders 2018.

Top End Health Service provides some specific information about use of interpreters when people who do not speak English as their first language are potential participants in research.

Does the Northern Territory have specific requirements for Clinical Trials Research Agreements and Collaborative Research Agreements?

The NTCTCU refers Agreements to legal counsel at the Solicitor for the Northern Territory to review Clinical Trials and Collaborative Research Agreements.

All Agreements are between the sponsor and/or the collaborative research group and the Northern Territory of Australia as the legal entity.

The Northern Territory prefers to use the relevant Medicines Australia Clinical Trials Agreement template.

Does the Northern Territory request any amendments to the Standard amendments to the Medicines Australia Clinical Trials Agreement template?

Yes, standard amendments requested include:

  1. An NT specific signature block for the execution of the Agreement to comply with the NT Contracts Act.
  2. Amendments via the Special Conditions schedule that note:
    • The Benefit and Appointment of Agents when the Territory party to the Agreement is a Health Service;
    • The Northern Territory of Australia’s status as a Self-Insurer.

Further information about these amendments is available through the NTCTCU (clinical.trials@nt.gov.au)

Does the Northern Territory accept other Legal Agreements?

Yes, but legal review is required and can take considerable time for both parties to agree to all clauses.

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Last updated: 07 December 2019

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