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St Vincent's Centre for Applied Medical Research

Site Authorisation – Private

In Research Governance:

  • Site Authorisation – Public
  • Site Authorisation – Private
  • Post Authorisation
  • Research Contracts and Agreements
  • Honorary Appointments
  • TGA eCTN Submission
  • Access Requests

On This Page:

  • Minimum Documentation Requirement – STE/SSA Submission
  • Submission Requirements
  • Submission Resources
  • Mandatory ICH-GCP R3 Training requirement
  • Head of Department (HOD) Approval and Support
  • Radiation Safety Assessment

 

St Vincent’s Hospital Sydney Research Office provides STE/SSA governance review for the following private (non-PHO) sites:

  • St Vincent’s Private Hospital Sydney
  • The Mater Hospital Sydney 
  • The Victor Chang Cardiac Research Institute

Please note the following:

  • All human research projects must undergo STE/SSA review before site authorisation can be granted by the Executive Director (or their delegate) of the organisation.
  • STE/SSA applications for the above listed private sites are managed via email.
  • HREC approval is required before site authorisation can be granted.

Minimum Documentation Requirement – STE/SSA Submission

Minimum documentation required for submission of an STE/SSA (please use the appropriate checklist to ensure your application is complete):

  • Standard cover letter listing all documents being submitted as you wish them to appear on the authorisation email
  • Proof of HREC approval
  • Full suite of HREC approved documents
  • Site-specific versions of patient facing materials
  • STE/SSA form with appropriate Head of Department and Head of Supporting Department sign off
  • Proof of ICH-GCP R3 Certification for all study team members listed on the STE/SSA form
  • Contracts (where applicable) – the need for an agreement will be determined as part of governance review
  • Study budget (for budget tool please refer to Resources for Researchers)
  • SVHS FPR number (if applicable, refer to Fees and Payments)

Submission Requirements

All new STE/SSA applications (single or multisite projects) for the St Vincent’s Private Hospital Sydney, the Mater Hospital Sydney and Victor Chang Cardiac Research Institute sites:

  1. Must be submitted to the Research Office (svhs.research@svha.org.au) via email
  2. Must be accompanied by the standard cover letter (link below) listing all documents being submitted exactly as they are to appear on the authorisation email 
  3. The SSA Submission Form – Private sites (link below) must be used 
  4. The SVHS – Private Sites – Submission Checklist (link below) must be used

Submission Resources

Mandatory ICH-GCP R3 Training requirement

  • Proof of current ICH-GCP R3 training is 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 and beyond including but not limited to staff of St Vincent’s Hospital Sydney, St Vincent’s Private Hospital Sydney, the Garvan Institute, the Victor Chang Cardiac Research Institute and the Mater Hospital Sydney.
  • ICH GCP certificates must be renewed every 3 years
  • St Vincent’s Hospital Sydney staff members and members of other SPHERE partners can access ICH-GCP R3 training modules via SPHERE: 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.

Head of Department (HOD) Approval and Support

Head of Department support and sign off must be sought for each department involved in the study prior to submission of the application.

It is recommended that Heads of Department are made aware of the research project and agree to the conduct of the study well in advance of the submission of the application. Often this process is what causes delays in the review and authorisation of applications.

An alternative Head of Department approval is required if the listed investigator is also listed as a Head of Department. This alternative approval should be the individual’ s manager. 

Radiation Safety Assessment

A Radiation Safety Report is required in studies involving humans who are exposed to radiation which is in addition to that received as part of their normal clinical management. Either the Radiation Safety Report, or a Letter of Declaration from the PI/CPI stating that all radiation exposure falls within the site’s standard of care must be submitted with the SSA application. More information can be found on our Research Ethics – New Submissions page.