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Governance applications are submitted and assessed via the Site Specific Assessment (SSA) form through the SA Health Governance and Ethics Management System (GEMS). GEMS user guides are available on the SA Health website.

Research governance is responsible for:

  • the protection of research participants and staff
  • the safety and quality of research
  • privacy and confidentiality
  • finance
  • adequate resources (financial, human, equipment and infrastructure) for research to proceed at the chosen site
  • necessary expertise and experience of researchers (medical officers must be credentialed in order to conduct clinical research); if not, relevant training is planned before carrying out their role in the research study
  • compliance with relevant laws, regulations, policies and codes of conduct relating to matters such as privacy, confidentiality, consent, bio-safety, professional standards, and radiation safety
  • risk management
  • monitoring arrangements.

Governance is a framework through which institutions are accountable for the research they allow to be conducted under their auspices. Prior to commencing a research study at CALHN, research governance authorisation must be obtained in addition to Human Research Ethics Committee (HREC) approval.

Honorary Research Affiliate (HRA)

We recognise the benefit of collaborating with researchers from different institutions, allowing key expertise, skills and knowledge to enhance research and improve health outcomes.

The Honorary Research Affiliate (HRA) position enables this collaboration providing successful applicants with read only access to CALHN databases for the purpose of individual research projects.

CALHN considers applications from:

  • researchers who are either collaborating with a CALHN employee on a research study
  • students involved in clinical research under the supervision of a CALHN employee.

Access to SA Health electronic systems for retrieving personal data will not be granted solely for convenience. Alternative methods of data extraction, including via an SA Health employee, must be explored first.

A Clinical Research Agreement (CRA) will be required between CALHN and the applicants employing or educational institution.

All signatures on the HRA application form must be obtained via DocuSign; leave signature and date fields blank when submitting.

  • Post graduate students
  • CALHN employed researchers conducting the research in an external affiliation (e.g. PhD)
  • researchers from the broader SA Health Network (e.g. SALHN or NALHN)
  • any researchers employed outside of the SA Health network.

If you are interested in a HRA position please submit the following documentation to Health.CALHNResearchGovernance@sa.gov.au or Health.CALHNResearchHR@sa.gov.au.

Site Specific Application (SSA)

CALHN is responsible for conducting site specific application (SSA) reviews of research that is considered greater than low risk and which is taking place at a CALHN site:

  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital
  • Hampstead Rehabilitation Hospital
  • Mental health services at Glenside Health Service
  • Statewide Rehabilitation Services at the Repat Health Precinct.

In addition CALHN has a range of specialised statewide services including:

  • Breastscreen SA (BSSA)
  • SA Dental
  • SA Medical Imaging (SAMI)
  • SA Pathology
  • SA Pharmacy
  • SA Prison Health Service
  • DonateLife SA.

The authorisation of a site specific application by research services means that the governance for the project is approved and that the study can commence.

SSAs are required to be submitted for both investigator initiated and commercially sponsored projects.

Governance applications are submitted and assessed via the SSA form through the SA Health Governance and Ethics Management System (GEMS). GEMS user guides are available on the SA Health website.

Submit a copy of the reviewing HREC approval letter and all of the documents approved by the reviewing HREC through the SA Health Governance and Ethics Management System (GEMS). GEMS user guides are available on the SA Health website. Include any site specific documentation requiring local research governance approval for example the site specific Participant Information and Consent Form (PICF).

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Governance

Research GEMS
Investigator Initiated Site Specific Assessments (SSA)
Agreements

Clinical trials

Confidentiality Disclosure Agreements (CDAs)
Clinical Trial Research Agreements (CTRAs)
Commercially Sponsored Site-Specific Assessments (SSA)
Clinical Trial Notification Scheme (CTN)
Clinical Trial Approval Scheme (CTA)
Clinical Trial Invoicing
Clinical Trial Facilities and Research Unit Information

This page was last updated 23 May 2025.

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