Submitting for Governance & Site Authorisation (SSA)
HREC review and Site Specific Assessment (SSA) are two distinct processes relating to the ethical approval and institutional authorisation of research involving humans. They are both components of Research governance.
Research governance is a framework through which institutions ensure that research conducted conforms to relevant institutional, jurisdictional and national standards and laws. Research governance addresses protection of research participants, the safety and quality of research, privacy and confidentiality, financial probity, legal and regulatory matters, risk management and monitoring arrangements and promotes good research culture and practice.
Site Specific Assessment (SSA) is a key element of research governance, and involves the review of HREC approval (either by St Vincent’s HREC or another Certified Lead HREC), HREC approved documents, Site Specific Assessment (STE/SSA) form, study budget, Clinical Trial Research Agreements (CTRA), insurance and indemnity arrangements. Research projects undergo Site Specific Assessment before authorisation can be granted by the Executive Director (or delegate) of the organisation.
Relevant policy documents and guidelines are also listed on the Resources for Researchers page of our website.
Mandatory ICH-GCP Training requirement:
- Please note that as of 31 January 2022, proof of current ICH-GCP training will be required for ALL study site team members named in an STE/SSA application.
- This applies to ALL clinical research studies and NOT just to clinical trials.
- This mandate applies to researchers based anywhere on the Darlinghurst Precinct including staff of St Vincent’s Private Hospital, St Vincent’s Clinic, and the Garvan and Victor Chang Institutes.
- Note that ICH GCP certificates must be renewed every 3 years
The following link can be used by St Vincent's Hospital staff members and members of other SPHERE partners to access ICH-GCP training modules:
ICH - GCP Training
Non-St Vincent's Hospital staff members and staff from non-SPHERE partners are required to seek training opportunities from their own institutions.
St Vincent’s Hospital Research Office provides STE/SSA/governance review for the following sites:
- St Vincent’s Hospital (via REGIS)
- St Joseph’s Hospital (via REGIS)
- Sacred Heart Health Service (via REGIS)
- St Vincent’s Private Hospital (please contact the Research Office)
- The Mater Hospital (please contact the Research Office)
- The Victor Chang Cardiac Research Institute (please contact the Research Office)
Submission for Site Specific Assessment via REGIS:
Submission for Site Specific Assessment (STE/SSA) via REGIS:
ALL new applications (single or multisite projects) submitted for governance review in REGIS must be accompanied by the standard cover letter:
Cover Letter Template - Submission for Governance Review
Please ensure that your cover letter lists all documents being submitted.
To submit a study for governance review by the Research Governance Officer, please use the following checklist:
REGIS Checklist - SSA or LNRSSA Submission
Your submission must be made via REGIS
All responses to requests for additional information must be made via REGIS and must be accompanied by the standard response cover letter:
Cover Letter Template – Response to RGO
Submission for Site Specific Assessment for Private Sites (SVH Private, TMH, VCCRI) ONLY:
ALL new applications (single or multisite projects) submitted for governance review for the above private sites must be submitted via email and must be accompanied by the standard cover letter (see link above).
Please contact the Research Office in first instance via SVHS.Research@svha.org.au (02 8382 4960) for the appropriate forms.
All responses to requests for additional information must be accompanied by the standard response cover letter (see link above).
Clinical Trial Research Agreements
Standard Clinical Trial Research Agreements have been developed by the NSW, QLD, VIC and SA Health Departments in conjunction with Medicines Australia. Templates are available on the Medicines Australia website.
Please note that St Vincent's Hospital Research Office is unable to accept contracts with special conditions listed in Schedule 4/7 unless evidence of NSW Health approval of the clauses is provided. This is a NSW Health requirement. Information relating to the process by which special conditions may be submitted for review to the relevant Health Department is also available on the Medicines Australia.
- All external researchers who are not current St Vincent’s Hospital employees and are involved in the conduct of a research project at sites for which St Vincent’s Research Office provides governance review are required to obtain an Honorary Appointment.
- This includes but is not limited to undergraduate students, graduate students, research fellows and university academics.
- The need for an Honorary Appointment is identified by the Research Officers during STE/SSA review. An external researcher may not commence research related activities at sites under the governance of St Vincent's Research Office until the Honorary Appointment has been granted.
- The requirement for an Honorary Appointment may be waived if evidence of current ClinConnect Clearance is provided however this is at the discretion of the Research Office Manager.
- Please contact the Research Office Directly for additional important information on the Honorary Appointment process.
Tel: 02 8382 4960