Clinical trials requirement
All clinical trials that are recruiting from an Northern Territory (NT) Health site or are using NT Health data will need to comply with the requirements of the Research Governance Office (RGO) as stipulated within the content below.
The purpose of site specific assessment (SSA) is to enable NT Health to consider whether the project should be conducted and supported at the proposed site/s. The SSA is a separate process to ethical and scientific review of the project, however the SSA is dependent on ethical approval.
Research projects requiring SSA
Research projects conducted at any NT Health facility must undergo an SSA, the SSA assessment undertaken will depend on the type and risk of research.
You may submit your SSA at the same time that you apply for NT HREC approval. However, it is important to be aware that governance authorisation is not granted until evidence of Human Research Ethics Committee (HREC) approval is provided to the RGO.
If you wish to make concurrent submissions, please make this clear in your covering letter.
Documentation for SSA
The supporting documentation required for the SSA review is listed on the SSA checklist, please ensure you complete the SSA checklist.
A covering letter should be included with your submission documentation. The covering letter will include at minimum:
- research title
- HREC reference numbers (when available)
- documents submitted (including version numbers and dates)
- study personnel details (see ‘Study personnel’ below).
Site personnel qualifications and training
The site PI is responsible for ensuring all persons involved in the research have adequate qualifications and experience to perform delegated tasks and have received appropriate and adequate training in research-related procedures.
Investigators and Study Coordinators need to complete training in the principles of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
The site PI is required to maintain an up-to-date site staff signature and delegation log in their site files that list all the research staff performing research specific activities within the study.
Non-NT Health staff and / or students may only access identifiable NT Health patient data and NT Health facilities (site) 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.
These requirements apply to all non-NT Health staff or students identified in the SSA submission. It also applies to all non-NT Health staff or students who wish to work on the study at any time in the future.
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.
Accessing NT Health identifiable data
All non-NT Health staff or students must provide the RGO 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
- completed External agency access to clinical systems form endorsed by the study site PI.
Accessing NT Health sites
All non-NT Health staff or students must comply with NT Health policy and procedures. The RGO will determine during the SSA application, what documentation is required to be provided to the RGO before access to sites will be granted. This will include:
- appropriate qualifications and professional registration where relevant
- WWCC for all child related work
- 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.
Changes to study personnel
There may be instances where new study personnel are added to a study, or existing study personnel are removed.
The study site PI must notify the RGO of any changes in:
- site PI (relevant ethics approval letters and current short CV are required for the new 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
- any changes to the police clearance and WCCC status of any member of the research team.
The NT is a signatory to the NMA scheme and will provide updates on the phased full implementation of the scheme. Please refer to the HREC of NT Health and Menzies School of Health Research application process for details on how to complete application.
Note that application under NMA may result in further specialist ethics review which may result in additional requirements for the project.
Note also that this process requires close and continuing communication between Coordinating Principal Investigator, Primary NMA reviewing HREC, and the NT Health RGO
Once a site specific assessment (SSA) is approved, research governance authorisation will be provided. The terms and conditions of research governance authorisation are included in the authorisation email from the 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 authorisation of the study.
In the event there are other conditions of research governance authorisation, these will be detailed in the research governance authorisation letter.
A condition of the research governance authorisation continued approval is the provision of a copy of the reviewing HREC annual report and response. This must be provided to the RGO (firstname.lastname@example.org and / or email@example.com) within 30 days of each anniversary of the initial HREC approval for the duration of the HREC approval period.
The RGO will send an email to the Principal Investigator (PI) and site contact person to acknowledge receipt of the annual report. Any further actions that may be required will be detailed in this email.
An amendment application is required when any of the following occurs:
- changeover of site PI, Associate Investigator (AI), study coordinator or non-NT Health employee that is accessing confidential NT Health data or NT Health facilities for research purposes
- addition or removal of NT Health sites
- significant changes are made to the protocol or information sheets that could affect the ethical acceptability of the study
- protocol amendments.
All significant safety issues or any serious unexpected serious adverse reactions (SUSAR’s / USADEs / URSAEs) that occurred to an NT Health participant must be reported by the site PI to the RGO (firstname.lastname@example.org, and / or email@example.com) within 72 hours. The report will include a copy of the documents submitted to the lead HREC and the HREC acknowledgement email / letter.
Please see the local ethics committee website for details, also refer to the National Health and Medical Research Council guidance document:
National Health and Medical Research Council (2016). Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods. Canberra: National Health and Medical Research Council.
Final report, site closure
It is the responsibility of the PI to complete a final report at the completion of their research project to the HREC of the NT Department of Health and Menzies School of Health Research. The report should also be forwarded to the RGO firstname.lastname@example.org or email@example.com.
Clinical trials notification (CTN) details
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 RGO.
Once site authorisation has been granted, the sponsor can submit the CTN form for the site under NT of Australia (legal entity). The RGO must be provided with a copy of the submitted information and the TGA notification letter as soon as practicable.
Please contact the 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.
Top End Health Service
|Name of approving authority:||The Northern Territory of Australia, C/O its agency The Department of Health (through Top End Health Service)|
|Approving authority contact:||Associated Professor Bhavini Patel|
|Position:||Executive Director Research, Transformation and Change|
|Contact phone:||08 8922 7764|
Central Australia Health Service
|Name of approving authority:||The Northern Territory of Australia, C/O its agency The Department of Health (through Central Australia Health Service)|
|Approving authority contact:||Dr Sam Goodwin|
|Position:||Executive Director of Medical and Clinical Services|
|Contact phone:||08 8951 7998|
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 DoH self-insurance arrangements where approval from at least one of the following; Top End Human Research Ethics Committee or Central Australia Human Research Ethics Committee 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 RGO must be provided with an executed copy prior to final SSA authorisation.
The RGO will review ‘indemnified party’ details and insert the signature block for the ‘institution’ prior to approval for sign off, please contact the RGO.
The 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 RGO. This insurance will indemnify the participants involved in the research project and requires submission to the RGO.
Clinical trial contracts, indemnities - NT Health as a participating site
|Funders||Indemnity||Certificate of currency||Clinical trial contract|
|Commercial sponsor (external)||Sponsor’s insurance cover must indemnify the local site, investigator and research staff||Sponsor covers participants involved in the research project||MA CTRA standard template|
|Investigator initiated (external)||
NT DoH covers NT Health employees under self-insurance arrangements. |
Non-NT health employees accessing NT Health facilities require indemnification by their current employer / organisation (captured in the CTRA)
|CRG (administering institute) covers participants involved in the research project||MA CRG CTRA template|
Clinical trials research agreements
If your study involves an agreement between NT Health and any other party, then this agreement must be submitted to the 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 three months. The RGO will arrange legal review on your behalf as required. The NT prefers to use the relevant Medicines Australia Clinical Trials Agreements template, the RGO will insert a signature block for the institution and standard schedule 4 special conditions required for the NT. Please speak with the 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, this provides a suite of commercially sponsored templates only.
MA and MTAA Clinical trial research agreement template - institutional details
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.
Top End Health Service
|Name of institution:||The Northern Territory of Australia, C/O its agency The Department of Health (through Top End Health Service)|
|Address:||Royal Darwin Hospital, 105 Rocklands Drive, Tiwi NT 0810|
|ABN:||84 085 734 992|
Central Australia Health Service
|Name of institution:||The Northern Territory of Australia, C/O its agency The Department of Health (through Central Australia Health Service)|
|Address:||GPO Box 2234, Alice Springs NT 0871|
|ABN:||84 085 734 992|
Participant information sheet - RGO details
Site specific requirements
The participant information sheets and informed consent form require the insertion of the NT Government logo where NT Health is the site and a paragraph informing participants how to contact the RGO. Please use the below paragraph as a guide for insertion into the participant information statement (PIS). This is in addition to the ethics and site PI contact details.
For TEHS sites - PIS
The conduct of this study at [name of site] has been authorised by Northern Territory Health. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer on 08 8922 7764 or email firstname.lastname@example.org and quote reference number [insert SSA reference number].
For CAHS sites - PIS
The conduct of this study at [name of site] has been authorised by Northern Territory Health. Any person with concerns or complaints about the conduct of this study may contact the Research Governance Officer on 08 8958 2554 or email email@example.com and quote reference number [insert SSA reference number].
Biosafety, chemical and radiation safety
All research that involves biosafety or radiation must comply with the relevant requirements.
Regulation of gene technologies and related therapies
By law to abide by the Commonwealth scheme for the regulation of genetically modified organisms (GMO) in Australia as defined in the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001. Dealing with a GMO without appropriate authorisation under the Act is an offence, and subject to penalties.
For further information, go to the Office of the Gene Technology Regulator (OGTR).
The RGO must be supplied with an approval letter from the Institutional Biosafety Committee and a licence for dealings with GMO that has been reviewed and approved by the TEHREC or CAHREC.
A research project involving the use of ionising radiation must be noted by HREC according to the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (ARPANSA, 2005).
For multi-centre trials under NMA where ethical review is undertaken by a single central HREC then it is the responsibility of the Coordinating Principal Investigator to submit one radiation safety risk assessment for the lead HREC. This will be compared to the local sites radiation risk category. For further information please visit Australian Radiation Protection and Nuclear Safety Agency.
For single site ethical review, the radiation safety in research involving the exposure of human volunteers to ionising radiation is the responsibility of the institution at which the research is being undertaken. The PI at each site is responsible for ensuring that any advice provided by a Medical Physicist in relation to a particular research project is complied with in full.
The site PI is required to either:
- provide a letter stating that radiation exposure is part of normal clinical management/care
- if radiation exposure is additional to that received as part of normal clinical management / care, an independent assessment report by a Medical Physicist of the total effective dose and relevant organ doses including risk assessment.
In addition, you will be required to seek support from the Head of the Medical Imaging Department.
It is recommended to avoid delays that you contact the Operations Manager Territory Pathology early in the research process to ensure feasibility and authorisation of the research, call 0437 918 911.
CRG or investigator initiated
All CRGs or investigator initiated clinical trials are required to provide a letter / email support from the Director of Territory Pathology. If you require medical pathology testing above that of normal care, any additional handling or storage of specimen / tissue, additional slides / stain, histology or transport then you will need to provide further details directly to Territory Pathology. Territory Pathology will advise on any costs incurred by the clinical trial. If the division under which the research is occurring is expected to cover the costs this will need support from the divisional head.
All commercial sponsors are required to contact Territory Pathology directly for any pathology requirements inclusive of access to pathology results. Territory Pathology will advise if the service provided can be included on the clinical trials research agreement or a separate service agreement. Please contact the RGO for contact details or further information.
Please inform the RGO if you are entering into a separate service agreement with Territory Pathology.
Territory Pathology will provide references ranges on request.
Investigational drugs / therapeutics - pharmacy
Clinical trials occurring in NT Health hospitals or health facilities that are administering drugs and / or therapeutics require pharmacy authorisation. The appropriate position to provide pharmacy authorisation will depend on the services required and the location of the study activity. If the clinical trial involves any of the service activities outlined below please ensure the appropriate pharmacist is contacted during the feasibility phase of the clinical trial to avoid delays or refusals. At time of contact additional guidance will be provided by the pharmacist for prescription requirements or any legislative processes that are specific to the NT Acts.
- Storage including temperature controls
- Monitoring and adverse event recognition, management and reporting.
Please contact the RGO for advice on the appropriate contact position required for pharmacy support / authorisation and for the current fee schedule.
Head of department endorsements
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. 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 email or a letter of support.
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. In instances where 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 endorsement.
The RGO will facilitate the final authorisation for the research which is provided by:
- TEHS the Executive Director, Research Transformation and Change
- CAHS the Executive Director of Medical and Clinical Services.
Last updated: 15 September 2020
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