Governance submissions are reviewed upon receipt. Ethics submission closing dates do not apply to SSA submissions.
To generate a Site Specific Assessment form (SSA) access the Online Forms website. The SSA is generated from the HREA form. To generate the SSA:
- Select the ethics application from your list of projects and then click on the SSA tab.
- Create and complete a new SSA Form.
- Lock the form when all information is complete. To do this, access the 'Submission' tab and select 'Generate Submission Code'.
- View the completed SSA and generate a PDF.
- Obtain required signatures and send via email with all accompanying documents to SESLHD-RSO@health.nsw.gov.au.
NOTE: If a watermark appears over your PDF SSA, the form has not been locked and is still in a draft version. Do not submit draft/unlocked versions as they can not be accepted.
Documents to be submitted with SSA forms are detailed here.
Hard copy, soft copy and electronic signatures are all acceptable. Please only include the people that are proposed to work on that study at the nominated site for that SSA. Don’t include the names of people at other sites on your SSA form – it will raise unnecessary questions and cause delays.
- Local investigators should be nominated in the SSA form and will also need to sign to indicate they are participating in the study.
- If another department is going to provide a service for your research, (for example providing a blood test, dispensing and storing drugs or a scan etc.), the head of that department will need to authorise the SSA form as 'Head of Supporting Department'.
- If you’re planning to access an existing collection of health records that are external to your department, the manager of that collection will need to sign as 'Authority for Data Provision'.
- The 'Head of Department' where the research is primarily conducted will need to authorise the form. If the Head of Department is also an investigator on the research, then their direct line manager will need to authorise this project instead. Researchers can’t authorise their own projects.
- Do not obtain signatures for the 'Declaration of the Chief Executive'. The Research Governance Officer will sign the form and make a recommendation to the delegate of the Chief Executive based on a review of this application.
- Access 'Project Details' via the 'Projects' page.
- Select the project identifier to open and edit the application.
- Attach all documents that have been approved by the HREC including your ethics application, protocol, participant information and consent form.
- When you complete the SSA, the SESLHD Research Governance Office will be notified.
IMPORTANT NOTE: All researchers nominated for a site must have a REGIS account before you can complete the SSA.
If your study is a Clinical Trial of a Drug or Device sponsored by a commercial company or collaborative group, there will be some additional documentation that you’ll need to attach to your SSA submission.
Sponsored trials should also adopt one of the Medicines Australia templates for a Clinical Trial Research Agreement, please also find the templates here. In addition to commercial and collaborative group led research, this will also include research being conducted by a Clinical Research Organisation and post marketing studies. Ensure the Sponsor is an Australian organisation and that the correct institution details for the Local Health District inserted
If you’re collaborating in a clinical investigation of a device, use the Medical Technology Association of Australia templates instead.
Both the Sponsor and PI will need to sign the CTRA before submitting with the SSA to the Research Support Office. The Research Governance Officer will arrange for signature by the Chief Executive on behalf of the Institution.
Medicines Australia has also developed a standard indemnity template agreement. This should accompany your SSA application. The Research Governance Officer will arrange for signature by the Chief Executive for this document.
The MTAA also have a standard indemnity template for clinical investigations of a device.
You also need to ask the Sponsors representative for evidence of Insurance. If the research is a commercially sponsored clinical trial, there are specific requirements for the insurance policy which the Sponsor should be aware of. Collaborative groups have less stringent requirements, but the Research Governance Officer will need to be satisfied that the policy is adequate to cover the intended research.
Australian state and territory Departments of Health have signed a Memorandum of Understanding for mutual acceptance of ethical and scientific review of the multi-centre human research projects undertaken in Public Health Organisations. Currently Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participating in National Mutual Acceptance (NMA).
In 2018 some NMA jurisdictions have moved from the common Online Forms research application platform to various other platforms. For information on where to complete SSA applications for NMA studies, please click here.
The Royal Hospital for Women (RHW) is now a highly active research institution in all areas of perinatal care. The Perinatal Academic Group (PAG) was developed at the RHW to review new trial applications, discuss resource implications and oversee a research strategy for the future.
For research conducted in the Royal Hospital for Women Labour Ward, the Perinatal Academic Group will need to provide a letter of approval. For more information on what is required, please email Anne Lainchbury (Anne.Lainchbury@health.nsw.gov.au). Please find required forms/templates here.
Please refer to pages 2 and 3 of the Policy Directive which sets out the fees to be charged by public health organisations for carrying out a research governance review of commercially sponsored research (site specific assessments) and review of commercially sponsored research by their Human Research Ethics Committees (HRECs).
- Submit everything at once with a covering letter itemising the contents of the submission. If any documents are missing or pending, please list these documents on the covering letter.
- Electronic submissions will be accepted but not for legal documents requiring original signatures.
- Provide relevant contact details. You may need to answer queries regarding this submission.
- It’s always faster to submit a complete application than submit in multiple stages and then respond to queries later.