Steps for filling in and submitting an SSA Form
Step 1 – Generating the SSA
Step 2 –Locking and submitting the form
Step 3 – Who signs the SSA and who doesn’t?
Step 4: I’m collaborating on a clinical trial…
Step 5: Other authorisations may be necessary…
Step 6: What else do I attach to my SSA?
Step 7: Tips for submitting the form
Step 1 – Generating the SSA
A Site Specific Assessment form (SSA) is used to gain authorisation for research at public health sites within New South Wales. An SSA Form will be created by the same individual that wrote the National Ethics Application Form (NEAF) for that research project using the ethicsform.org/Au website.
If you’re coordinating the project and you wrote the ethics application, generate an SSA from the NEAF application form using the ethics website. To do this, select the ethics application from your list of projects and then click on the SSA tab. You should then have an option create a new SSA Form.
If you have agreed to participate in a multi-site study and don’t know how to fill in the SSA, create an account for the ethicsform.org/Au website and ask the coordinating researcher on the project to generate an SSA form for your site. Ask the coordinator to transfer the unfinished form to the account you just created via the website. Then you should be able to accept the form (Click on Transfer Requests after hovering over the My Projects menu option) and complete any necessary details. Add as much detail as possible and ask the research coordinator or the Research Support Office if you have any difficulty.
Step 2 –Locking and submitting the form
When you have completed the SSA form, this form will need to be “locked”. Only lock the form when you’ve added in all necessary information (…if you want to know who to include as signatories before locking the form, read step 3). When accessing your SSA form on the ethics forms website, click on the Submission tab. Then click on Generate Submission Code. Please note, this will not submit the document automatically; however it will remove the DRAFT watermark on the form.
To view the completed locked document, click on Generate PDF.
If the watermark is still there when you view the .pdf version of the SSA, the form has not been locked. Do not submit this version because it won’t be accepted as a draft document.
Step 3 – Who signs the SSA and who doesn’t?
Signatures can be ink signatures with hardcopies forwarded to the Research Support Office. Scans of the ink signatures that are forwarded electronically will also be accepted. Signatures can also be electronically generated using the ethicsform.org/Au website.
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 contributing to the research at other sites on your SSA form – it will only 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 on 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.
Step 4: I’m collaborating on a clinical trial…
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. Ask the Sponsors representative for a copy of the CTN or CTX form. This is a form that will eventually be submitted to the TGA. The Principal Investigator (PI) will complete Section 2 and a representative from the reviewing HREC will complete and sign Section 2 before it is submitted to the research support office with the SSA form. Do not obtain signatures on behalf of the institution (Section 4) for the CTN. This will be arranged by the Research Governance Officer.
Sponsored trials should also adopt one of the Medicines Australia templates for a Clinical Trial Research Agreement. 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 – see below.
/ 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.
Step 5: Other authorisations may be necessary…
If participants in your research are going to be exposed to ionising radiation as part of the research, the risk of radiation exposure should be assessed locally by the Radiation Safety Officer.
Assessments may also be necessary if there are biohazard or chemical safety risks.
For research conducted in the Royal Hospital for Women Labour Ward, the Perinatal Academic Group will also provide a letter of approval.
Where tissue samples are being sent to another institution, it may be necessary for a Material Transfer Agreement to be arranged between the institutions. Ask at the Research Support Office if you need further guidance.
Step 6: What else do I attach to my SSA?
Attach every current document that has been approved by the HREC. If the research is not yet approved, provide the documents that were submitted to the HREC. This will include the NEAF and could also include a protocol, master participant information and consent form, and an investigators brochure. If the study has HREC approval, attach that confirmation letter also. If you’re conducing multi-centred research, you should also include local versions, clean and tracked changes, of the participant information and consent form which will include the SESLHD logo, the hospital details and any contact information for the research team.
If you’re not using a Clinical Trial Research Agreement, include a budget explaining how the local costs of the research are to be met and any funding arrangements that may be in place.
For all members of the research team, include a copy of a recent CV.
Step 7: Tips for submitting the form
· 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.
· Submissions can be made in person to the Research Support Office or via post. Electronic submissions will be accepted but not for legal documents requiring original signatures like contracts.
· Provide relevant contact details. You may need to answer queries regarding this submission. Respond to any queries that are raised.
· It’s always faster to submit a complete application than submit in multiple stages and then respond to queries later.
Guidance to complete SSA – NEAF 02.02.2017