Health research

Research overview

On 1 July 2021, the Health Service Act 2021 (HSA) commenced establishing a single integrated entity responsible for the delivery of health services as defined by section 9 of the HSA.

The CEO of the Agency (NT Health) is the System Manager in accordance with section 15 of the HSA. The functions and powers of the System Manager include amongst others planning for the delivery by NT Regional Health Services of health services and health support services and negotiating and entering into agreements. The HSA establishes NT Regional Health Services as the local hospital network for the purposes of the National Health Reform Agreement (NHRA).  NT Regional Health Services forms part of the NT Health and is not a separate legal entity.

NT Health extends across five regions that make up the Regional Health Services:

  • Top End
  • Big Rivers
  • East Arnhem
  • Central Australia
  • Barkly.

Embedding research is central to the achievement of NT Health’s goals and strategic objectives PDF (946.7 KB) to provide best practice health care that is effective, and evidence based because of our research. NT Health conduct research in a range of capacities and in partnership with a range of organisations to:

  • Develop a priority research agenda aimed at improving health and health care for all Territorians.
  • Grow research capacity and capability, including the establishment of NT wide governance and support structures.
  • Strategic sourcing of funding for research that optimises health outcomes for Territorians.
  • Ensure curriculum and workforce development provides quality teaching and learning.
  • Implement, test and embed research-based solutions to Territorian health care challenges in our health system.

Research Governance

To conduct short term clinical audit, case study, or simple internal quality assurance activity, using routinely collected data that will be de-identified with no deviation from standard care and no human interaction, please complete the Ethics Clearance Form for Clinical Audits, Quality Assurance, and Case Studies.

Please note that advanced trainees, registrars, medical students, and higher degree candidates should be identified as Co-investigators and not as Principal Investigator.

For students listed as one of the Investigators, please also compete the Student Deed of Undertaking form.

Researchers are advised to include evidence of endorsement by the local Regional Health Service authorising delegates (i.e. Unit Head, Co-Director or General Manager or Regional Executive Director) prior to submission to the NT Health RGO by completing the relevant endorsements sections at the end of this form (section 10) or by submitting email endorsement when lodging this to the NT Health RGO. Please ensure that email endorsements include the full project title. If unsure of the appropriate authorising delegate(s), please contact NT Health RGO for advice.

NOTE: Organisational authorisation section will be signed by the Executive Director of Research once the NT Health RGO have undertaken their review.

The completed and signed form should be submitted electronically to the NT Health RGO nthealth.rgo@nt.gov.au for review. The NT Health RGO will forward this form to the ethics office (NT HREC) for expedited review.

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Site PI will be notified by the NT Health RGO.

Both NT HREC approval and NT Health RGO organisational authorisation are required before a research project can commence at any NT Health site(s).

All research conducted with NT Health staff, clients/patients, sites and/or data must be approved through the correct governance processes which broadly address the quality, safety, privacy and confidentiality, risk management, financial management and ethical acceptability of research.

Processes and guidelines have been developed to support the changes to the institutional governance procedures for conducting research within NT Health, to bring the NT in line with national best practice in research governance. The role of the NT Health Research Governance Office is to ensure research is conducted according to established ethical principles, guidelines for the responsible research conduct, relevant legislation, regulations and NT Health policies.

All research projects conducted within NT Health must designate a NT Health-employed individual, qualified by training and experience, to serve as the NT Health Site Principal Investigator (PI). The PI must have sufficient authority, relevant scientific knowledge, and the requisite training to personally carry out or supervise all aspects of the project at NT Health. NT Health authorises the Site PI to assume ultimate responsibility for the scientific, technical and administrative aspects of the research project, even when certain tasks have been delegated to other members of the research team.

The governance review undertaken will depend on the type and risk of research. Assessment of applications occurs through site specific assessment (SSA), clearance for clinical audits, quality assurance and case studies, and/or access request for research review; assessing the resources at the NT Health site and whether they’re sufficient to ensure the satisfactory conduct and completion of the project.

NT Health  is committed to implementing the Australian Commission on Safety and Quality in Health Care (ACSQHC) National Clinical Trials Governance Framework to align with the actions in Clinical Governance Standard and Partnering with Consumers Standard of the NSQHS Standards which are already embedded in routine practices of health service organisations. The NT Health Research Governance Office (RGO) is responsible for:

  • Ensuring awareness of the importance of the NHMRC: National Statement on Ethical Conduct in Human Research and the NHMRC: Australian Code for the Responsible Conduct of Research across the organisation.
  • Monitoring relevant regulatory and policy developments to ensure changes are incorporated into local policies and procedures in a timely manner.
  • Leading the development and implementation of systems and implementation of best practice policy, procedures, and standardised systems within the relevant health system to improve the conduct and governance of research projects in collaboration with the governing body, managers, clinicians, patients, consumers and sponsors.
  • Providing information, education and advice on research governance matters to stakeholders involved in the conduct and management of research projects in accordance with national and local policies, guidelines and other reference material adopted by the Northern Territory.
  • Monitoring and evaluating research activity within NT Health throughout the project duration.
  • Undertaking risk management assessments regarding research services and procedures to promote responsible research conduct.
  • Implementing systems for the management of complaints about research projects including misconduct and/or fraud and manage complaints, misconduct or conflicts of interest related to the conduct of authorised research projects.
  • Conducting or co-ordinating audits of research projects, where required.
  • Preparing reports to regulatory bodies as required.
  • Maintaining records, including databases and filing systems.
  • Determining compliance with relevant legislation and policies.

The governance review/SSA is a separate process to the ethical review and should be conducted in parallel to the ethics approval process. It is not necessary to await the ethics outcome before preparing and submitting a governance/SSA application to the NT Health RGO.​ However, ethics approval must be obtained and provided to the NT Health RGO as part of the final governance review. Both ethics approval and research governance/SSA organisational authorisation are required before a research project can commence at any NT Health site(s).

Please refer to the workflow for overview of NT Health governance and ethics application process. The workflow also includes standard processing times for both governance and ethics authorisation/approval.

A human research project that requires support from a Health Service in the form of access to NT Health patients, staff, tissue or data but does not involve the conduct of research at any facilities, locations or services (site) under the control of that Health Service, is not required to undergo a governance review using the Site Specific Assessment (SSA). Please complete the access request form for research projects via the online submission.

An Access Request review using this form is required when the research project involves:

  • participant recruitment through posters, leaflets, handouts, and letter of invitation (but not recruitment through direct contact with potential participants or enrolment);
  • distribution of surveys and questionnaires through personnel of the Health Service (but not collation and analysis of responses at that Health Service); and
  • access to data or tissue held at the Health Service (but not processing or analysis at that Health Service).

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Coordinating Principal Investigator (CPI)/Principal Investigator (PI) will be notified by the NT Health RGO.

Please note that request for completion of an SSA may be requested at the discretion of the reviewing Research Governance Officer.

All research projects conducted with NT Health staff, patients, sites and/or data, require an SSA as a component of research governance. The SSA form is an information gathering tool used to assess the research projects impact on each relevant NT Health Region. One SSA may be completed for research being conducted across multiple NT Health regions, so long as all appropriate delegates have provided their endorsement for the research.

For research projects involving Primary Health Care (PHC), an SSA should be submitted to the RGO, whereby the RGO will arrange for the research proposal to have the relevant endorsements and review conducted. The information provided will be reviewed by the appropriate authorising delegate(s) from NT Health to ensure that there are resources available to effectively conduct a research project at the nominated NT Health site(s). The responsible delegate will provide the NT Health RGO with their support or a reason why the project is not supported.

The SSA enables NT Health RGO’s commitment to the research in terms of:

  • Alignment and contribution of the research to NT Health strategic goals
  • Adequate resources which have been identified as appropriate, accountable and available (financial, human, equipment, consumables and infrastructure) for the research to proceed at NT Health site(s)
  • Researchers have the necessary expertise and experience to carry out the work, or have provided evidence they will undergo the relevant training before they carry out their role in the research study
  • Compliance with relevant laws, policies, and codes of conduct relating to matters such as indemnity insurance, privacy, confidentiality, consent, bio-safety, professional standards, and radiation safety

Once completed, the SSA form plus electronic copies of all supporting documents must be submitted to the NT Health RGO via the online submission.

The NT Health RGO will assess the submitted form and attachments. If further information is required, the Site PI will be notified by the NT Health RGO.

Both NT HREC approval and NT Health RGO organisational authorisation are required before a research project can commence at any NT Health site(s).

Therapeutic Goods Administration of Australia (TGA) requires all CTNs to be submitted via their online submission portal. It is the responsibility of the study sponsor to submit the application and pay the submission fee.

A CTN form must not be submitted to the TGA online portal until both ethical approval and research governance authorisation have been granted.

NT Health as a site (not sponsor)

The sponsor / collaborative research groups (CRG) is required to complete and validate (but not submit) the online CTN form and provide a copy of this validation form to the NT Health RGO.

Once site authorisation has been granted, the sponsor can submit the CTN form for the site under NT of Australia (legal entity). The NT Health RGO must be provided with a copy of the submitted information and the TGA notification letter as soon as practicable.

Please contact the NT Health RGO in the first instance if you are submitting a CTN form, have any queries about the CTN submission process, or to discuss options for your study.

Research Agreement

If your study involves an agreement between NT Health and any other party, then this agreement must be submitted to the NT Health RGO for review.

This includes any confidentiality disclosure agreements, research collaboration agreements (for example, funding agreements, Head agreements), data sharing agreements, or contracts. These agreements need not adhere to a specific format and can be based on local templates of other institutions or organisations. Please be aware that non-standard clinical trial and collaborative research agreements will require legal counsel which can lengthen approval times by a minimum of 2 months.

The NT Health RGO will arrange legal review on your behalf as required. The NT prefers to use the relevant Medicines Australia Clinical Trials Agreements template, the NT Health RGO will insert a signature block for the institution and standard schedule 4 special conditions required for the NT. Please speak with the NT Health RGO to ensure a timely approval process.

For medical device research, the templates for contracts and indemnities are maintained by Medical Technology Association of Australia (MTAA), this provides a suite of commercially sponsored templates only.

The NT of Australia is the legal entity that can enter into research agreements. Where fees are chargeable, the appropriate fee will be charged as outlined in the NT Health fees schedule .

MA and MTAA Clinical trial research agreement template – institutional details

Name of InstitutionNorthern Territory of Australia, through its agency the Department of Health
Address105 Rocklands Drive, Tiwi, NT 0810
ABN84 85 734 992
Contact for notices[Site PI details]
Fax for Notices 
Phone number[Site PI contact]

Insurance and indemnity

The NT of Australia, care of its agency the Department of Health (DoH) provides self-insurance.

Indemnity - NT Health employees

NT Health employees conducting a research project in the capacity of their employment with NT Health are automatically covered by NT Health self-insurance arrangements where approval from the reviewing HREC and NT Health RGO has been obtained.

Indemnity - commercial sponsor

For commercially sponsored clinical trials or contract research organisations (acting on behalf of the sponsor), the sponsor must supply evidence of its insurance cover. A sponsor’s insurance cover must indemnify the local site, investigator and research staff. For all commercially sponsored clinical trials, use of the Medicines Australia standard indemnity form is the preferred form executed on behalf of the sponsor prior to the site specific assessment (SSA) submission. If a sponsor has not signed the indemnity form prior to SSA submission, the NT Health RGO must be provided with an executed copy prior to final SSA authorisation.

The NT Health RGO will review ‘indemnified party’ details and insert the signature block for the ‘institution’ prior to approval for sign off, please contact the NT Health RGO.

The NT Health RGO will arrange for the indemnity to be executed on behalf of the institution, please note the executed version will be sent out with the authorisation email.

Indemnity - collaborative research group

For CRGs the indemnity arrangements are outlined in the clinical trials research agreement, in general, the NT of Australia will cover NT Health employees conducting research activities under a CRG, however if the research activities are performed by a non-NT Health employee on NT Health facilities or with NT Health confidential data the non-NT Health employee’s organisation must provide indemnity for their employee.

Certificate of currency - requirements for all clinical trials

For clinical trials, the entity that has accepted the role of the sponsor will be required to submit a certificate of currency (CoC) to the NT Health RGO. This insurance will indemnify the participants involved in the research project and requires submission to the NT Health RGO.

The participant information sheets and consent form (PISCF) require the insertion of the NT Health name block/logo where NT Health is the site and a paragraph informing participants how to contact the NT Health RGO. Please use the below paragraph as a guide for insertion into the participant information statement (PIS). This is in addition to the reviewing ethics and site PI contact details.

The conduct of this study at name of site has been authorised by Northern Territory Health. Any person with concerns or feedback (complaints or compliments) about the conduct of this study may contact the NT Health Research Governance Officer on 08 8922 7764 or email nthealth.rgo@nt.gov.au and quote reference number insert SSA reference number.

The NT Health RGO facilitates a researcher initiated ‘bottom up’ process. Researchers are encouraged to discuss proposed research projects with the unit heads and site managers as the first step in planning research.

Any division or department that is involved in the research must endorse the research being conducted in their department. This includes departments that are actively involved in the research, for example wards, pharmacy, radiology, medical imaging. It may also include departments that are not actively involved, but will experience some impact from the conduct of research, for example, participants will be recruited from the department. All relevant divisional or department heads must confirm support either by signing the SSA form or providing an email of support.

Depending on the type and risk of research, the SSA may also need to be endorsed by the relevant institutional head.

It is a conflict of interest for any person who is an Investigator, whether as the Principal Investigator or Associate Investigator, to also provide endorsement as the head of department. If the head of department is an Investigator, the endorsement must be provided by the next highest level of authority. For example, where a department head is also the Principal Investigator, the divisional head must provide the endorsement.

If unsure of the appropriate authorising delegate(s), please contact the NT Health RGO for advice.

Applications are assessed against the following criteria and the organisation must be satisfied that:

  1. All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
  2. All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role;
  3. The research is relevant to the site;
  4. The research is consistent with the strategic objectives PDF (946.7 KB) of the organisation
  5. There is no conflict of interest for the researchers or that the declared conflict of interest is acceptable;
  6. There is evidence of compliance with indemnity requirements;
  7. Requirements for access to organisational data are clear and comply with legislative requirements;
  8. Data management, privacy and confidentiality requirements are described, and comply with legislative requirements;
  9. The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery;
  10. There are suitable and adequate facilities and resources for the research project to be conducted at this site;
  11. The resource contribution by the site is clear;
  12. The research project and resource implications have been discussed with relevant staff/delegates;
  13. There is a clear organisational benefit of participation in the research;
  14. The organisation benefit of participating in the research is consistent with the resource contribution; and
  15. That the research, once completed, is provided back to NT Health via the relevant (authorising) research governance office and disseminated/implemented to the relevant staff and/or participants.

This will be the final review for the SSA form post support by all other relevant delegates. The NT Health RGO will facilitate the final authorisation for the research which is provided by the Executive Director of Research. The Site PI will be notified by the NT Health RGO of the outcome via email.

Once NT Health RGO organisational authorisation is granted, the terms and conditions of research governance authorisation are included in the authorisation email from the NT Health RGO, and are in addition to the terms and conditions of Human Research Ethics Committee (HREC) approval.

Researchers are required to comply with reporting requirements and other conditions. Failure to comply will have significant implications for the ongoing site authorisation of the research project. In the event there are other conditions of research governance authorisation, these will be detailed in the research governance authorisation email.

The link to access the NT Health RGO post authorisation reporting forms is provided on approval of your project. For any projects approved prior to the introduction of our online submission form, or if you have misplaced your return link, please email nthealth.rgo@nt.gov.au and quote your SSA reference number.

Site commencement

Once the authorised research project is ready to commence at an NT Health site(s), it is the responsibility of the site PI to notify the NT Health RGO of project commencement date via the online NT Health RGO Site Commencement Form, for which the link will be provided on authorisation of the research.

Project amendment

It is the responsibility of the site PI to complete an amendment application when any of the following occurs:

  • changeover of site PI
  • addition or removal of research personnel at NT Health site(s) – both NT Health or non-NT Health staff
  • addition or removal of NT Health site(s)
  • changes to project documentation, including protocol, PICF, etc.
  • other changes to the research project that might have an implication to NT Health.

Please complete the online NT Health RGO Amendment Form and provide any supporting documents, the relevant HREC correspondence and approval (usually provided by Sponsor/CPI) to the NT Health RGO. The link to access the online Project Amendment form is provided to the site PI on authorisation of the research. For any research approved prior to the introduction of the online submission or if you have misplaced the link, please contact nthealth.rgo@nt.gov.au and quote your reference number.

The NT Health RGO will send an email to the site PI and site contact person to approve the project amendment(s). Any further actions that may be required will be detailed in this email.

Progress report

It is the responsibility of the site PI to complete a progress report to the NT Health RGO for each research project regardless of the progress of the research or whether it has commenced. A condition of the research governance authorisation continued approval is the provision of a copy of the reviewing HREC annual report and response.

Progress reports are due on the anniversary of the reviewing HREC approval.

Progress Report must be provided to the NT Health RGO within 30 days of each anniversary of the initial reviewing HREC approval for the duration of the HREC approval period. Failure to submit a report to NT Health RGO will result in the Head of Department/Division being notified.

Please complete the online NT Health RGO Progress Report and provide the relevant supporting documents, the relevant HREC correspondence and approval (usually provided by Sponsor/CPI) to the NT Health RGO. The link to access the online Progress Report form is provided to the site PI on authorisation of the research. For any research approved prior to the introduction of the online submission or if you have misplaced the link, please contact nthealth.rgo@nt.gov.au and quote your reference number.

The NT Health RGO will send an email to the site PI and site contact person to acknowledge receipt of the progress. Any further actions that may be required will be detailed in this email.

Final report - site closure

It is the responsibility of the site PI to complete a final report at the completion of their research project to the NT Health RGO via the online NT Health RGO Final Report Form, Study Close Out Checklist and Declaration of Archiving Research Documents along with providing all supporting documents, the relevant HREC correspondence and acknowledgement (usually provided by Sponsor/CPI).

The NT Health RGO will send an email to the site PI and site contact person to acknowledge receipt of the final report. Any further actions that may be required will be detailed in this email.

It is the responsibility of the site PI to report any significant safety issues or any serious unexpected serious adverse reactions (SUSAR’s / USADEs / URSAEs) that occurred to NT Health participants or within NT Health, to the NT Health RGO within 72 hours.  The report will include confirmation that the incident has been reported in the NT Health risk management system, a summary of any immediate actions that were undertaken, the risk rating, a copy of the documents submitted to the lead HREC and the HREC acknowledgement.

To obtain a link for submission of an online report, email nthealth.rgo@nt.gov.au.


Ethics

NT Health sponsors the NT Health and Menzies School of Health Research Human Research Ethics Committee (NT HREC) that provides ethical review for all health related research conducted in the NT. This Committee is accredited with the National Health and Medical Research Council for multi-centre ethical review and operate in accordance with National Statement on Ethical Conduct in Human Research (2007). The NT HREC may accept National Mutual Acceptance (NMA) applications as the lead HREC when the lead site and Coordinating Principal Investigator are based in the Northern Territory.

Contact

The Human Research Ethics Committee (HREC) of Northern Territory Health and Menzies School of Health Research (NT HREC)

Phone: (08) 8946 8687 or (08) 8946 8692
Email: ethics@menzies.edu.au

For more information go to the Menzies website.


Data access

NT Health RGO organisational authorisation will need to be provided to the Data Release Request Team prior to the requested data being released.

NT Health can provide data collections for service provision information, epidemiological analysis and health related research at a detailed level (while meeting privacy requirements) to researchers to support a better understanding of the health of Territorians and measures which can assist in improving health outcomes. Requests for identifiable information require reasonable justification as to why non-identifiable information is not sufficient for the purpose of the data request.

To apply for access to de-identified administrative data sets, researchers should consult information on the Health Data page.

Contact

NT Health Data Quality and Governance Unit

Phone: (08) 8999 2770
Email: datareleaserequests.doh@nt.gov.au


Responsibilities of NT Health Site Principal Investigators and Endorsers

Responsibilities of endorsers

The role of the site endorser(s) is to assess whether the research is appropriate to be conducted at the relevant site by evaluating the research according to criteria to be considered for granting Site Specific Approval. On-the-ground assessment and endorsement is done by on-site Unit heads, Co-Directors and/or General Managers (collectively called endorsers).

The role of Unit Heads is to assess:

  • There are suitable and adequate facilities and resources for the research project to be conducted at this site.
  • The research is relevant to the NT Health site and aligns with the strategic goals.
  • The Organisational benefit of participating in the research is consistent with the resource contribution.
  • The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery.
  • All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.
  • All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.
  • There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable.
  • There is evidence of compliance with indemnity requirements.
  • Requirements for access to organisational data are clear and comply with legislative and NT Health policy requirements.
  • Data management, privacy and confidentiality requirements are described, and comply with legislative requirements.

The role of Co-directors and/or general managers is to assess:

  • There is a clear organisational benefit of participation in the research.
  • The research is consistent with the strategic objectives of the organisation.
  • The research project and resource implications are within the allocated budget of the service.
  • The Site Principal Investigator (Site PI) is responsible for obtaining approval from the relevant endorsers as outlined in the SSA Form. Endorsements can be in the form of email or letter and once obtained should be forwarded to the NT Health RGO.
  • If an endorser is concerned about the research they are encouraged to discuss concerns with the site PI and the NT Health RGO. If approval is withheld, the rationale for doing so, or requests for additional information and/or guidance is provided by the endorser.

Responsibilities of Site Principal Investigators (PIs)

All research projects conducted within NT Health must designate an individual qualified by training and experience to serve as the NT Health Site Principal Investigator (PI).

The PI must have sufficient authority, relevant scientific knowledge, and the requisite training to personally carry out or supervise all aspects of the project at NT Health. NT Health authorises the PI to assume ultimate responsibility for the scientific, technical and administrative aspects of the research project, even when certain tasks have been delegated to other members of the research team.

All research team members responsibilities
  • Maintain documented evidence that they have adequate qualifications and experience to perform delegated tasks and have received appropriate and adequate training in research-related procedures.
  • Maintain documented evidence of accredited training in the principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) every three years.
  • Maintain an up-to-date delegation log of appropriately qualified persons to whom the investigator has delegated significant research-related duties.
  • Notify the NT Health RGO of any changes in site PI, addition / removal of Associate Investigators, study coordinator / project contact person and all Non-NT Health staff and students accessing identifiable data or NT Health facilities, and any changes to the police clearance and working with children’s clearance (WWCC) status of any member of the research team.
Additional responsibilities for non-NT Health research team members accessing patient identifiable data

In addition to the above responsibilities:

  • complete and endorse External agency access to clinical systems form
  • an initial national Police check (valid within six months)
  • WWCC if the research involves accessing data of children under 18 years of age
  • evidence of indemnity.
Additional responsibilities for non-NT Health research team members accessing NT Health sites

In addition to both the above responsibilities:

  • ensure all research members comply with NT Health policy and procedures
  • maintain documented evidence of appropriate qualifications and professional registration boards
  • satisfy immunisation requirements as per NT Health policy
  • evidence of indemnity.

Non-NT Health staff and students

Non-NT Health staff and/or students may only access identifiable NT Health identifiable data and/or NT Health facilities/sites to perform specified research activities as delegated by the site PI. Authorisation for these members of the research team is gained through the site specific assessment (SSA) approval process and requires adherence to all relevant NT Health policies and guidelines.

For example, and to avoid doubt, these requirements extend to:

  • any monitors, Clinical Research Associates (CRA) or other non-NT Health personnel working on the study in any capacity who have access to identifiable NT Health patient information
  • any monitors, CRAs or other non-NT Health personnel working on the study in any capacity who are at any time on-site at an NT Health facility for research related purposes. An exemption can be sought for those non-NT Health staff and students who are on-site but not in a position to access any identifiable data and/or child related work.
  • any researcher or research group who wishes to access NT Health data for the purposes of creating a registry and who can at any time access identifiable NT Health patient data. In this instance, every person who is non-NT Health staff or student must satisfy the above requirements if they can at any time access identifiable NT Health patient data.
  • For students undertaking any research activities as part of their student placement/training, please sign the Student Deed of Undertaking.

Accessing NT Health identifiable data

All non-NT Health staff or students accessing NT Health identifiable data must provide the Site PI with a:

  • an initial national Police check is required (valid within six months)
  • Working with children’s clearance (WWCC) if the research involves accessing data of children under 18 years of age
  • Signed Deed of Confidentiality and Compliance Form.

Use and disclosure of health information for research and statistical purposes must be consistent with Information Privacy Principle 2.1(ca) and any applicable guidelines issued by the NT Information Commissioner under IPP2.1(ca)(iv) & section 86(1)(a)(iv) - Use and disclosure of health information for research and statistical purposes. Patient/client level information will only be disclosed for research purposes if all such requirements have been complied with.

Please get in touch with the NT Health RGO for NT Health clinical systems access request form for external researchers once the research project is granted organisational authorisation.

Accessing NT Health facilities/sites

All non-NT Health staff or students accessing NT Health facilities/sites must comply with NT Health policy and procedures. All non-NT Health staff or students must provide the Site PI with a:

  • appropriate qualifications and professional registration where relevant
  • WWCC for research activities involving children under 18 years of age
  • satisfy immunisation requirements as per NT Health policy.

For further information, refer to the working with children clearance on the Northern Territory Government website, and the Care and Protection of Children Act 2007 (NT). For NT Health employees, the NT Health policy is available on the NT Health intranet.

Please get in touch with the NT Health RGO for NT Health facilities access request form for external researchers once the research project is granted organisational authorisation.


Fee schedules

NT Health aims to recover some of the costs for activities that are required to support research undertaken within its facilities. Fees are chargeable for all site specific assessment (SSA) applications with the exemptions applied for NT Health based investigator initiated studies.

All fees listed in this schedule are exclusive of goods and services tax (GST).

The Research Governance Office (RGO) is required to review all applications for conducting research in NT Health regional health services. SSA fees will be invoiced upon activity being requested, regardless of the approval status of the application.

Clinical trial with full commercial sponsorship

ActivityFees
Initial site specific assessment review fee$3,300 (single site)
Plus $440 (per additional site1)
Amendment submission fee - major RGO review and approval2$500
Amendment submission fee - minor RGO review and approval3$250
Completion fee$440

Clinical trial / research funded by grant / collaborative group / not-for-profit organisation

ActivityFees
Initial site specific assessment review fee$350
Review of amendments feeNil
Contract amendments feeNil
Completion feeNil

  1. Multiple primary health care sites will be considered a single site for the purpose of billing. Each hospital will be considered a single site.
  2. A major amendment is defined as an amendment to the protocol or any other supporting documentation that is likely to affect to a significant degree:
    • the safety or physical or mental integrity of the participants of the trial
    • the scientific value of the trial
    • the conduct or management of the trial
    • the quality or safety of any investigational medicinal product used in the trial.
  3. A minor amendment is defined as changes to the details of research that have no significant implications for participants or for the conduct, management or scientific value of the study and can be regarded as minor amendments (sometimes referred to as administrative amendments). Examples as follows:
    • correction of typographical errors in the protocol or other study documentation
    • amended contact details for the sponsor or project staff
    • appointment of new support staff.

Invoicing process

RGO revenue monies will be invoiced and managed by the RGO. Invoices will be sent directly to the sponsor or coordinating institution and remittance will be required prior to final approval/non-approval of the SSA application.

Contact

For more information, contacts us.

Clinical trial fees for industry sponsored clinical trials

ActivityFees
Site set up fee
Includes feasibility, protocol review, SSV, budget negotiation and CTRA, RGO SSA submission
$4,500 - primary
$3,000 - satellite
(to be paid on governance approval)
Trial initiation fee including SIV$1,500 payable on site activation
SSA preparation$1,000 - primary
$1,000 - satellite
Administration fee, commencing year 2 on anniversary of SIV (computer access, consumable extra)$1,500 - primary
$1,000 - satellite
Amendment submission fee - major i/c PICF site preparation$500 (maximum of 3 PICFs, hourly rate applies to further PICFs)
Amendment submission fee - minor w/o PICF site preparation$250
Online training undertaken by PI per hr
or CRC per hr
$226
$85
Monitor visits$450 per day/per monitor
Safety reporting to Governance/Ethics
  • Insurance
  • Annual report
  • IDMC, SUSAR, DSUR
$100 per item
Other correspondence to Governance: primary site$100/occasion of service
Preparation and submission of SAE (including follow up) documentation and reports (site specific) to sponsor and RGO$250 per SAE
Re-consent to PICF$100
Site close out fee$1,000
Archiving storage fees 15 years on site (if stored here)
  • Box retrieval (if required) from archiving
$2,000 plus transfer fees by invoice if not paid by sponsor
  • $100 per box retrieved

ActivityFees
Pathology set up fee$280
Haematology panel$23.73
Pathology test fees 
AST$13.58
ALT$13.58
ALP$13.58
Total bilirubin$13.58
Urea$13.58
Creatinine$13.58
Phosphate$13.58
Calcium$13.58
Magnesium$13.58
Sodium$13.58
Potassium$13.58
Chloride$13.58
LDH$13.58
Albumin$13.58
Amylase$13.58
Lipase$13.58
GGT$13.58
Uric acid$13.58
Glucose$13.58
CRP$13.58
Blood drawn for Central Labs (serum chemistry profile), Including preparation and shipment to Central Lab$50
Coagulation (prothrombin time (including INR where appropriate), activated partial thromboplastin time, thrombin time (including test for the presence of heparin), test for factor XIII deficiency (qualitative), Echis test, Stypven test, reptilase time, fibrinogen, or 1 of fibrinogen degradation products, fibrin monomer or D-dimer)$19.18 per item
Urinalysis$28.77
24-hour urine protein test albumin/creatinine ratio$28.49
Serum pregnancy test$14.21
Hep B (HBsAg) HBcAb included in price$77.98
HBV PCR$212.94
Hepatitis C antibody, HIV$59.29
Cortisol$42.70
ACTH$42.70
Short synacthen test$141.54
TSH$48.72
T3/FT3$48.72
T4/FT4$48.72
Cytology by FNA$95.41
Cytology by FNA with pathology attendance$238.49

Fees will be charged as per the pathology scheduled fee for tests and procedures above normal patient care.

Consultation with the pathology manager is recommended for quotation and to set up billing process.

Invoicing process

Pathology revenue monies will be invoiced and managed by the Pathology Department.

Contact

Royal Darwin and Palmerston Hospital

Laboratory Manager, RDH pathology administration
Phone: 0437 918 911

Alice Springs Hospital

Laboratory Manager, ASH pathology administration
Phone: 08 8951 7749

Site administrative costs

Activity
Fees
Establishment fee
Applicable when study is initiated and pharmacy documentation is prepared, irrespective of number of subjects recruited 
Commercially funded$1,800 per trial
Investigator initiated$900 per trial
Annual fee
Applicable on each anniversary of the study initiation meeting date; and during the year of trial closure if trial is not closed within 4 months of last pharmacy monitor visit or written notification of trial closure 
Commercially funded$1,500 per year
Investigator initiated$750 per year
Completion fee
Applicable after the last pharmacy monitor visit or written notification of trial closure 
Commercially funded$560 per trial
Investigator initiated$280 per trial

Yearly storage fees

Commercially funded studies only, payable from date of site initiation visit then 12 monthly thereafter.

ActivityFees
Room temperature storage$500 per year
Bulky* room temperature storage$700 per year
Refrigerated storage$1,000 per year
Bulky* refrigerated storage$1,200 per year
Freezer storage$1,000 per year
Bulky* freezer storage$1,200 per year
*Bulky goods are defined as any supply that requires a storage area greater than 40cm3

Dispensing/manufacture/sterile preparation fees

ActivityFees
Standard dispensing fees 
Commercial$100 per patient/visit
Investigator$50 per additional item per patient/visit
Complex dispensing fee (for example; 5 items or more per visit, manufacture requiring more than two vials per preparation)
Commercial$200 per patient/visit
Investigator$100 per additional item per patient/visit
Schedule 8 or restricted schedule 4
Commercial$120
Investigator$60
Complex dispensing with sterile or non-sterile manufacturing
Non-sterile manufacturing$155 per hour or $3 per capsule
Sterile preparationNot currently available on-site

Medicine/ancillary supply cost and handling fees

ActivityFees

Commercially funded

Pharmacy acquisition cost + 20% handling per item per order (capped at $155 per item per order)

Investigator initiated

Pharmacy acquisition cost only

Drug transfer

ActivityFees

Drug transfer to the patient when not onsite, and between primary and satellite sites, will incur an administrative fee for logistics, communications and packaging.

The sponsor will nominate their preferred * courier for commercial transport.

*If the preferred courier is unable to transfer the drug, the pharmacy service will contact the sponsor to confirm alternative options.

$155 per hour, plus commercial transport fee

Additional charges

ActivityFees
Returns storage fee$50 per month from 3 months,
where approval for destruction has not been received
On-site drug destruction$155 per hour - min charge $85 per occasion
Drug re-test date relabelling$155 per hour - min charge $85 per occasion
Remote pharmacy monitoring$155 per hour - min charge $85 per occasion
Clinical review (for example, drug interaction review, medication reconciliation or other, as requested)$155 per hour - min charge $85 per occasion
Online training requirement (any online training required, including any training required in addition to site initiation visit and for pharmacy manual or protocol amendments)$155 per hour per staff member required to undertake training
Patient Pharmaceutical Benefits Scheme co-payments (trials requiring PBS medications to be dispensed by the service, for example to maintain blinding, or additional medications that are not standard of care)PBS co-payment
After-hours services as requested by the investigator/sponsor
Overtime$155 per hour
Call-out$700 per call-out, plus $155 per hour after the first 3 hours
*All fees charged as per fee schedule in addition to after-hours service fees

Please note:

  1. Pharmacy reviews the fee schedule every year and reserves the right to implement the new schedule if the duration of the study exceeds 2 years.
  2. GST increment will be calculated on all items where relevant.
  3. For items not covered in this schedule of fees - fees will be calculated based on the estimated time to undertake the activity.

Contact

Fees only apply for non-standard of care imaging examinations and/or procedures.

ActivityFees
Medical imaging set up fee$1,000
Admin fee (applicable for each year of trial beyond the first 12 months)$800
RECIST reporting$250
Uploading to central review$150
Clinical trials coordinator
  • Imaging uploading
  • Imaging data queries
$85/hr
Disc burning fee$131 one copy
$146 two copies
Close out fee$300
Imaging fees  
CT neck/chest/abdomen/pelvis$802.90
CT head$322.56
CT head/neck/chest/abdomen/pelvis$1,125.40
CT chest with contrast$573.51
CT abdomen pelvis with contrast$688.31
CT abdomen no pelvis$516.18
MRI brain$564.48
MRI base of skull (neck) with contrast$627.20
MRI pelvis$564.48
MRI abdomen and pelvis$878.58
FDG PET$1,334
Biopsy fees (protocol dependent)TBC

Radiation safety report fees

ActivityFees
Initial report$1,500 or cost as per institution at time of report
Confirmatory reportUp to $550

Invoicing process

Radiology revenue monies will be invoiced and managed by the Radiology Department.

Contact

Royal Darwin and Palmerston Hospital

Director Medical Imaging Services, RDH Radiology
XrayAdminRDH.THS@nt.gov.au

Senior PET Technologist, Positron Emission Tomography
Pet.RDH@nt.gov.au

Alice Springs Hospital

Manager, Medical Imaging Services, ASH Radiology
RadiologyAliceHospital.THS@nt.gov.au

ActivityFees
Country travel (per visit fee to cover costs associated with reasonable travel expenses for those country patients who have to travel further than 100km to attend study related visits. Standard overnight accommodation approximately $220 per night. Sponsor will be notified and approval for any further additional costs to be negotiated).TBC with sponsor

If a study is extended for a protracted period, the study budget may require renegotiation.

If the project is terminated early, the sponsor is required to cover full costs associated with the study preparation and conduct including any HREC and RGO fees dues.

ActivityFees
ECHO$330.75
ECG$26.81

Submissions for new research

NT Health has transitioned to a new online research governance management system.  This system replaces the paper based site specific assessment (SSA) and brings the NT in line with other jurisdictions across Australia. The system has been built using a secure web platform for building and managing online databases.

All research conducted with NT Health staff, clients/patients, sites and/or data must be approved through the correct governance processes which broadly address the quality, safety, privacy and confidentiality, risk management, financial management and ethical acceptability of research.

The governance review undertaken will depend on the type of research and risk being proposed. Please select from one of the following submission options. For any queries relating to the type of submission for your project, please contact nthealth.rgo@nt.gov.au

For clinical audits, case studies or simple internal quality assurance activities, using routinely collected data that will be de-identified with no deviation from standard care and no human interaction, please complete the Ethics Clearance Form for Clinical Audits, Quality Assurance, and Case Studies, located on the Menzies School of Health Research website and submit it to nthealth.rgo@nt.gov.au. This form is not available for online submission at the current time.

To submit an SSA or an Access Request Form, please use below link

Please note the Research Governance Office will only begin reviewing your application once all required endorsements and supporting documents are received, this includes any draft research agreements. HREC approvals may be submitted at a later time once ethics approval is granted and we encourage you to submit your SSA whilst awaiting HREC approval.

For submissions relating to approved research including amendments and progress reporting, please refer to the initial authorisation email.

For any research approved prior to the introduction of the online submission or if you have misplaced your link, contact nthealth.rgo@nt.gov.au and quote your reference number.

Supporting Documents

Tools and research guidance

Guidelines

NT Government

National


Education and Training

NT Health Clinical Innovation and Research, supported by the Australian Teletrials Program, is providing free access to training for everyone who conducts clinical trials or would like to develop their skills in this area across Northern Territory. What is A-CTEC?

A-CTEC is a not-for-profit, member based education platform, hosting a suite of evidence-based, interactive clinical trials education opportunities suitable for a range of learning needs.

Why A-CTEC?

A-CTEC enables capacity and capability building of the clinical trials workforce through easy access to world-class education and training opportunities. It provides a collaborative forum to share resources, knowledge and expertise that also allows reporting for accreditation purposes. It provides:

  • Education and training that caters to the various levels of experience and competency of the clinical trials workforce
  • Courses which are interactive, practical, multi-modal and evidence-based
  • TransCelerate Good Clinical Practice Training
  • Role specific competency frameworks
  • Networking opportunities for the clinical trials workforce
  • Reporting for accreditation

Who is A-CTEC for?

The training available through A-CTEC will be valuable for: study investigators, study coordinators, research nurses, clinical trial assistants, clinical trial pharmacists, Human Research Ethics Committee (HREC), research governance officers, and all staff involved in clinical trials regardless of their role or location.

For further information or to access the training and education please visit A-CTEC website

Investigators and/or research personnel of clinical trials being conducted at NT Health must provide evidence of accredited Good Clinical Practice (GCP) certification undertaken within the previous 3 years.

Evidence of GCP certification will form a requirement for Site-Specific Assessment (SSA) authorisation. The site PI is responsible for ensuring respective members of the research team undertake GCP training prior to the commencement of the study and hold current certification throughout the project duration.

If you currently do not hold this or would like further information on gaining this certification, please refer to the TransCelerate-recognised GCP Training or contact the NT Health RGO for advice.

Flinders University offers free research support to NT Health staff. This can be advice on research questions, epidemiological study designs, data management and analysis or assistance with writing for publication. Statistical analysis support is also available. Contact Chris Rissel (PhD, MPH, BSCPscyh(Hons)) (chris.rissel@flinders.edu.au) for further information.

Flinders University has campuses in Alice Springs, Tennant Creek, Katherine, Nhulunbuy and Darwin.

For further information on education and training opportunities please contact nthealth.teletrials@nt.gov.au


Australian Teletrial Program – Northern Territory

A teletrial is a clinical trial that is delivered closer to home, particularly for regional, rural and remote patients. It includes groups of clinical trials sites that work together under the supervision of a lead clinician.

The Australian Teletrial Program (ATP) aims to improve access to, and participation in, clinical trials for rural, regional and remote Australians. The program will create an interconnected clinical trial system to enable all Australians equal access to clinical trials that aim to improve their health and wellbeing.

The ATP is funded by the Commonwealth Government Medical Research Future Fund (MRFF) - National critical infrastructure initiative - 2019, rural, regional and remote clinical trial enabling infrastructure initiative. The program has been funded $75.2 million over 5 years to bring clinical trials closer to home for patients in Queensland, Victoria, Tasmania, South Australia, Western Australia and the Northern Territory.

Contact the ATP-NT team for further information on how the program is being implemented across the Territory.

Contact us

Australian Teletrial Program – NT team

B4, L1, Yellow Wing, Royal Darwin Hospital

Email: ATP‑NT@nt.gov.au

Phone: 08 8922 6110 or 08 8922 8708

For more information on the program, please visit the Australian Teletrial Program website

For more information on all active clinical trials across NT Health, please visit NT Health clinical trials register.

For more information on education and training opportunities, please visit Education and Training.


NT Health clinical trials register

If you have any queries in regards to any of the above clinical trials, please contact NT Health Research Governance Office (RGO) on 08 8922 7561 or nthealth.rgo@nt.gov.au

Active Teletrials in NT

Study short title/acronym Health Condition Study Full Title Link to ANZCTR/Clinicaltrials.gov Site Principal InvestigatorPrimary SiteSatellite Sites
AGILE-Echo Heart Failure / Valve Heart Disease Use of Artificial intelligence-Guided echocardiography to assIst cardiovascuLar patient managEment https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=21108&isClinicalTrial=TrueDr Angus Baumann Alice Springs HospitalTi Tree CHC

Hermannsburg CHC

Tennant Creek Hospital

ASCENDPancreatic Cancer A Randomised, double-blinded phase II study of gemcitabine and nab-paclitaxel with CEND-1 or placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382607&isReview=trueDr Sandy Tun MinQueen Elizabeth Hospital. SARoyal Darwin Hospital
SOCRATES HCC studyEarly Hepatocellular CarcinomaA randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HCC

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381818&isReview=true

Dr Kirsty CampbellFlinders Medical Centre SARoyal Darwin Hospital
TELEKINESIS Kidney Nutrition The Telenutrition and Kidney Health Study. A randomised controlled trial comparing the effect of providing nutrition support and advice using digital health to standard care on serum phosphate control in patients on dialysishttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381780&isReview=trueRachael SmalleyAlice Springs HospitalRoyal Darwin and Palmerston Hospital

Tennant Creek Hospital

Active Clinical Trials in NT

Study short title/acronym Health Condition Study Full Title Link to ANZCTR/Clinicaltrials.gov Site Principal Investigator
ACT-2 Cardiovascular/Type 2 Myocardial Infarction (MI) The Appropriateness of Coronary investigation in myocardial injury and Type 2 myocardial infarction https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374157&isReview=true Dr Hussam Tayeb
AMLM22 (IAPC) Acute myeloid leukaemia (AML) The International AML Platform Consortium (IAPC) Trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000248167 Dr Emma Palfreyman
ARiSE Fluids Septic shock Australian Resuscitation in Sepsis Evaluation: Fluid or vasopressors in Emergency Department Sepsis https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=19156&isClinicalTrial=True Dr Sandra Brownlea
ARROW Recurrent Wheeze/ respiratory ARROW – Assessing the Reduction of Recurrent admissions with OM-85 for preschool Wheeze https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380570&isReview=true Dr Kathryn Roberts
ASCOT COVID-19 (SARS-CoV-2) Australasian COVID-19 Trial (ASCOT): A multi-centre randomised clinical trial to assess clinical, virological and immunological outcomes in patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379542&isReview=true Dr Jane Davies
ASCOLT Colorectal Cancer ASCOLT: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancer. An International, Multi centre, Double Blind, Randomised, Placebo Controlled Phase III Trial. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365996&isReview=true Dr Narayan Karanth
ASPIRING Intracerebral Hemorrhage Antiplatelet Secondary Prevention International Randomised trial after INtracerebral haemorrhage (ASPIRING) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=19590&isClinicalTrial=True Dr Alvaro Cervera
AusHepChronic HBV, HCV, and HIV infectionsAustralian Hepatitis and risk survey in prisonshttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=21244&isClinicalTrial=TrueMr Dy Kelaart
BALANCE Urinary Tract Infection/Urinary Sepsis/Bacteraemia Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): Randomized Controlled Trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380457&isReview=true Dr Catherine Marshall
BEST Trial Bone & Joint Infections BonE and joint infections – Simplifying Treatment in children trial https://clinicaltrials.gov/ct2/show/NCT04538053?term=NCT04538053&draw=2&rank=1 A/Prof Joshua Francis
BETTERBronchiectasisA randomised controlled trial to determine if acute respiratory exacerbations (REs) be reduced during 12 months of treatment with oral erdosteine compared to placebo (equivalent volume or capsule) given twice daily among children and adults with bronchiectasishttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381193&isReview=trueProf Anne Chang
BLIPA-Aus Respiratory Tract Infections/Wheezing Oral bacterial lysate to prevent persistent wheeze in infants after severe bronchiolitis; a randomised placebo-controlled trial (Bacterial Lysate in Preventing Asthma – BLIPA-Aus) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382889&isReview=true Prof Anne Chang
BONANZA Severe Traumatic Brain Injury Brain Oxygen Neuromonitoring in Australia and New Zealand Assessment https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378178&isReview=true A/Prof Lewis Campbell
BREATH Bronchiectasis/Respiratory The BREATH Study: short and long-term effects of therapeutic exercise in children with bronchiectasis: a multi-centre randomised controlled trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377843&isReview=true Kim Clayworth
CAC-Women TrialCardiovascular diseaseThe Coronary Artery Calcium Scoring in Women with Novel Cardiovascular Risk Factors Trial (CAC-Women Trial)https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382996&isReview=trueProfessor Louise Maple-Brown
CAPTURE Advanced Breast Cancer CAPTURE: A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor-positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377949&isReview=true Dr Narayan Karanth
CARBUNCLE Surgical Treatment of Carbuncle Carbuncle RCT: Limited Excision versus Saucerisation   Dr Richard Bradbury
CaSPCancerCancer Screening Program. Comprehensive genomic profiling as a decision tool for targeted treatmenthttps://www.omico.com.au/wp-content/uploads/2023/11/Omico_CaSP_Information_sheet_v1.3.pdf 

or

https://www.omico.com.au/our-programs/cancer-screening-program-casp/
Dr Michail Charakidis
Deadly Ears in Deadly Hands Severe otitis media Deadly Ears at Discharge - A hospital-based randomised controlled trial of an additional ear and hearing assessment to inform discharge planning by a trained Aboriginal Ear Health Worker in Aboriginal children with chronic ear infection https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382700&showOriginal=true&isReview=true Prof Peter Morris
D-KIDS Acute Respiratory Infection D-Kids: Vitamin D supplementation to prevent respiratory infections among Indigenous children in the Northern Territory: a randomised controlled trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375278&isReview=true Prof Peter Morris
DYNAMIC III Colorectal Cancer Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12617001566325 Dr Narayan Karanth
EMBER-4Breast NeoplasmsA Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer - Full Text View - ClinicalTrials.gov

Dr Teesha Downton
EN-ACTAcute Coronary SyndromesExploring the utility of non-Invasive Coronary Angiography in Suspected Acute Coronary Syndromes with Low Level Troponin Elevation (EN- ACT)https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384764&isReview=trueDr Angus Baumann
ENACTAutism Spectrum DisorderEnvironmental Enrichment for infants: parenting with Acceptance and Commitment Therapy (ENACT)https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376446Melissa Reid
ENZAMET Prostate Cancer Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=4975&isClinicalTrial=True Dr Narayan Karanth
FRAIL-M Multiple Myeloma Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (FRAIL-M) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001199101 Dr Ferenc Szabo
Hearing for Learning Otitis Media/Conductive Hearing Loss The Hearing for Learning Initiative - an innovative community-based service-enhancement model to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory: a Phase III stepped-wedge cluster randomised controlled trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=18174&isClinicalTrial=True Prof Amanda Leach
HomeBase2 Chronic Obstructive Pulmonary Disease/Respiratory HomeBase2: An implementation trial to improve access to pulmonary rehabilitation in people with chronic obstructive pulmonary disease https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=18662&isClinicalTrial=True Coralie Branelly
INFERR Anaemia/Liver Disease/Kidney Disease Iron infusion in Haemodialysis Study: Intravenous Iron Polymaltose For Indigenous Patients with High Ferritin Levels on Haemodialysis: A Prospective Open-Label Blinded Endpoint Randomised Controlled Trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378517&isReview=true A/Prof William Majoni
INTEGRATE IIb Advanced Gastro-Oesophageal Cancer (AGOC) Randomised Phase III Controlled Trials of Regorafenib containing regimens versus standard care in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370302&isReview=true Dr Narayan Karanth
MEGA-ROX Critical Illness/Emergency Medicine The Mega Randomised Registry Trial Comparing Conservative vs. Liberal OXygenation Targets https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379432&isReview=true A/Prof Lewis Campbell
MoST Framework - Screening Molecular Screening/Cancer The Cancer Molecular Screening and Therapeutics (MoST) Program – A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370660&isReview=true Dr Michail Charakidis
MoST 6 (substudies 14-15) Cancer/NTRK1-3 positive tumours. Single arm, open label, signal seeking, phase IIa trial of the activity of larotrectinib in patients with advanced NTRK1-3 positive tumours. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377225&isReview=true Dr Michail Charakidis
MoST 7 (substudies 16-18) Advanced rare or neglected cancers Single arm, open label, signal seeking, phase II trial of Tremelimumab in patients with tumours with advanced rare or neglected cancers https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378934&isReview=true Dr Michail Charakidis
MoST 8 (substudies 19-20 & 35-36) Cancer/HER2 amplifications or mutations Single arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378088&isReview=true Dr Michail Charakidis
MoST 9 (substudies 21-22) Cancer/HER2 amplifications or mutations Single arm, open label, signal seeking, phase II trial of the activity of tucatinib plus trastuzumab in patients with tumours harbouring HER2 amplifications or mutations https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379978&isReview=true Dr Michail Charakidis
MoST 10 (substudies 23-24) Cancer/amplified D-type cyclins or CDK4/6 or inactivation of CDKN2A. Single arm, open label, signal seeking, phase II trial of the activity of Palbociclib in combination with Avelumab in patients with tumours with amplified D-type cyclins or CDK4/6 or inactivation of CDKN2A. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379754&isReview=true Dr Michail Charakidis
MoST 12 (substudies 27-30) Lung Cancer/Other tumours harbouring BRAF V600 mutations Single arm, open label, phase II trial of vemurafenib and cobimetinib in patients with advanced tumours harbouring BRAF V600 mutations detected by comprehensive genomic profiling https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379986&isReview=true Dr Michail Charakidis
MoST 13 (substudy 31) Cancer/NTRK fusions or ROS1 gene A single-arm, open-label, phase II trial of entrectinib in patients with advanced tumours harbouring NTRK fusions or ROS1 gene rearrangements detected by comprehensive genomic profiling https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381225&isReview=true Dr Michail Charakidis
MoST 14 (substudy 32) ALK gene alterations Non-small cell lung cancer A Single arm, open label, phase II trial of alectinib in patients with advanced tumours harbouring ALK gene alterations detected by comprehensive genomic profiling https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381213&isReview=true Dr Michail Charakidis
MoST 17 (substudies 38-39) Adv NSCLC harbouring MET exon 14 skipping mutations A single arm, open label, signal-seeking, phase II, trial of tepotinib in patients with advanced non-small cell lung cancer harbouring MET exon 14 skipping mutations detected by comprehensive genomic profiling https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381345&isReview=true Dr Michail Charakidis
MoST 19 (Substudies 41-42) Solid Tumour harbouring KRAS G12C mutation Single arm, open label, signal-seeking phase II study of Sotorasib (AMG-510) in patients with solid tumours harbouring KRAS G12C mutation. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383071&isReview=true Dr Michail Charakidis
My Baby's movements Fetal complications of pregnancy My Baby's Movements: a stepped wedge cluster randomised control trial to raise maternal awareness of fetal movements during pregnancy (My Baby's Movements Multi-Centre Trial) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365867&isReview=true Dr Sujatha Thomas
MYDAS-TMyelodysplasiaMDS05: Advancing therapies in Myelodysplasia: A multi-domain platform trial for patients with myelodysplasia investigating new treatments - The Master Protocolhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383226&isReview=trueDr Suthanthira Kannan
Ramamoorthy
ORVAC Viral Gastroenteritis Due to Rotavirus A phase IV, double blind, randomised, placebo controlled clinical trial of a third scheduled dose of RV1 rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=7011&isClinicalTrial=True Dr Bianca Middleton
PARROT Neurological impairment/Lower respiratory tract infection Prophylactic antibiotics to prevent recurrent lower respiratory tract infections in children with neurological impairment (PARROT) study https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378218&isReview=true Prof Anne Chang
PETAL Acute lower respiratory infection in children Preventing recurrent Acute Lower Respiratory infections in young Indigenous Children (PETAL) study https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377132&isReview=true Prof Peter Morris
PneuMatters Acute Lower Respiratory Infection Preventing early-onset pneumonia in high risk children through maternal immunisation: a multi-centre randomized controlled trial. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374381&isReview=true Dr David Simon/Prof Anne Chang
PREDICT-TBI Traumatic Brain Injury PREdiction and Diagnosis using Imaging and Clinical biomarkers Trial in Traumatic Brain Injury: the value of Magnetic Resonance Imaging and Artificial Intelligence https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380619&isReview=true A/Prof Lewis Campbell
PROMPT BOLUS Paediatric Shock, Septic Pragmatic Paediatric Trial of Balanced versus Normal Saline Fluid in Sepsis (PROMPT BOLUS) https://clinicaltrials.gov/ct2/show/NCT04102371?term=NCT04102371&draw=2&rank=1 Dr Anna Lithgow
QUICKSTARTHepatitis CSame-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=20365&isClinicalTrial=TrueJane Davies
RADARHodgkin LyphomaA randomised phase III trial with a PET response adapted design comparing ABVD +/- ISRT with A2VD +/- ISRT in patients with previously untreated stage IA/IIA Hodgkin Lymphomahttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=19950&isClinicalTrial=TrueDr Emma Palfreyman
REMAP-CAP Community-acquired Pneumonia, Influenza, COVID-19 Randomised, Embedded, Multifactorial, Adaptive Platform trial for Community Acquired Pneumonia https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=17743&isClinicalTrial=True A/Prof Lewis Campbell
RENO Rectal Cancer A Longitudinal Cohort Study of ‘Watch and Wait’ in Complete Clinical Responders after Chemoradiotherapy for Localised Rectal Cancer https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376810&isReview=true Dr Narayan Karanth
REPEAT Primary ciliary dyskinesia REPEAT Study: Improving outcomes of children and young adults with primary ciliary dyskinesia: a multi-centre, double blind, double-dummy, 2x2 partial factorial, randomised controlled trial https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377259&isReview=true Prof Anne Chang
ROCKet Chronic post-surgical pain Reduction of Chronic Post-surgical Pain with Ketamine-ROCKet Trial - A multicentre double-blind parallel-group placebo controlled randomised trial of the effect of perioperative ketamine on the risk of development of chronic post-surgical pain https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373323&isReview=true Dr Elystan Hughes
SPICE IV Critically ill patients/Sedation Mechanical Ventilation Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380209&isReview=true A/Prof Lewis Campbell
STARS Breast Cancer A randomised comparison of Anastrozole before and continued during adjuvant radiotherapy for breast cancer versus Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy. (STARS – Study of Anastrozole and Radiotherapy Sequencing) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=83913&isReview=true Dr Scott Caruthers
SUPER-EDCancer of unknown primarySolving Unknown Primary cancER Earlier Diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384740&isReview=true

Dr Narayan Karanth
TAPISTRYSolid TumorsTumor-Agnostic Precision Immuno-Oncology and somatic targeting rational for you (TAPISTRY) Phase II platform trialhttps://clinicaltrials.gov/study/NCT04589845Dr Michail Charakidis
TEACH-PD CRCT Kidney Disease Targeted Education ApproaCH to Improve Peritoneal Dialysis Outcomes – Cluster Randomised Controlled Trial (TEACH-PD CRCT) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=18600&isClinicalTrial=True Dr Bidhun Paulose
The National Australian HCV Point-of-Care Testing ProgramHepatitis CThe National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV InfectionStudy Details | The National Australian HCV Point-of-Care Testing Program | ClinicalTrials.govDr Dan Wilson
TORPIDO 30/60 Complications of premature newborns/ resuscitation Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on Outcome https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367049&isReview=true Dr Dennis Bonney
VALDAC Acute Myeloid Leukemia VALDAC: A phase 2 study of venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukaemia https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377157&isReview=true Dr Emma Palfreyman
WHEATNecrotising EnterocolitisWithHolding or continuing Enteral feeds Around blood Transfusion (WHEAT) to prevent necrotising enterocolitis (NEC) in preterm infantshttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377274Dr Mantho Kgosiemang

For closed clinical trials available on the list of closed clinical trials.


Contacts

NT Health Research Governance Office (NT Health RGO)

Block 4, Level 1, Yellow Wing, Royal Darwin Hospital, Tiwi NT 0810

PO Box 41326, Casuarina, NT 0811

Phone: (08) 8922 7561

Email: nthealth.rgo@nt.gov.au