Site specific assessment and research governance

Page contents: How to make a site specific assessment application | Accessing an SSA form | Participating Organisations' Contact Details | Further information

Early research governance action

Once sites are chosen, sponsors/CROs should promptly organise delivery of study documentation to Principal Investigators at all sites involved in the trial.  Principal investigators should seek sign-off from departments or authorities.  For example:

• Nursing
• Health information 
• Pathology   
• Other local requirements
• Interpreting services
• Pharmacy
• Tissue bank(s)
• Radiology/medical imaging
• Budget approval.

Research governance checklist for Principal Investigators

This checklist has been designed to provide guidance to assist PIs to meet the requirements of site specific assessment. A copy of the Research Governance Checklist must be attached to every SSA application form.

Research Governance Checklist for Principal Investigators (535kb, pdf)

How to make a site-specific assessment application

Site-specific assessment will require the researcher to complete the Site Specific Assessment (SSA Form) on the Online Forms for Research website (register an account online).

All Principal Investigators, including the Coordinating Principal Investigator, must complete an SSA Form.

The SSA Form addresses the resources, study budget details, site-specific policies, and declarations from departments, etc.  The organisation conducting the trial, following HREC approval, must authorise the SSA before a trial can commence at that site.

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Accessing an SSA Form

The Coordinating Principal Investigator is responsible for generating the SSA Form for all Principal Investigators at study sites and transferring the SSA Form to each investigator using the ‘transfer’ function in the Online Forms website.

An automatic email alert will be sent to each Principal Investigator indicating that an SSA Form is waiting for completion. Using the Online Forms for Research website the Principal Investigators must fill in the SSA Form.

Principal Investigators will receive electronic copies of the HREC (NEAF) application and supporting documents from the reviewing HREC Coordinator/Administration Officer. These are required as SSA supporting documents will automatically be uploaded on the Online Forms SSA.

You should upload all other site specific supporting documents electronically. If a document is not available electronically it must be submitted in hard copy. When your SSA Form is complete it must have a ‘submission code’ generated from the Online Forms website.

When completing the SSA Form some fields relating to declarations and authorisation are blocked as these are not to be completed by Principal Investigators. Signatures required for declarations can be obtained on the printed hard copy of the SSA document.

Submitting the SSA Form to the Research Governance Officer at your site

After generating an SSA 'submission code,' print, sign and provide a hard copy with supporting documents to the Research Governance Officer at your site. If the SSA Form is correctly completed the Research Governance Officer will validate the submission.

If the SSA is not validated the Research Governance Officer will notify the Principal Investigator and request that the SSA application is completed correctly.

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Participating Organisations' Contact Details

The following table contains the research governance contact details for organisations participating in the streamlined system. If you have any queries please contact the Coordinating Office Information line on (61 3) 9092 1987.

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4. Ongoing Communication with the Research Governance Officer

Your Research Governance Officer will assess the SSA Form and ensure all the required documents are completed including unique site documents.  The Research Governance Officer will make a recommendation regarding site specific assessment.

5. Authorisation of your SSA

Evidence of HREC approval must be provided before the CEO/delegate can authorise or not authorise the SSA.

Without CEO/delegate authorisation the study cannot commence at the site.

The study can commence at a trial site when HREC approval and SSA authorisation is complete.

Further information

For more information refer to the Standard Operating Procedures or see Contacts.

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