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St Vincent's Centre for Applied Medical Research

Site Authorisation – Public

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 St Vincent’s Hospital Sydney, a PHO site:

  • 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 St Vincent’s Hospital Sydney (a PHO) are managed via REGIS. 
  • HREC approval is required before site authorisation can be granted.
  • Investigator initiated clinical trials for which St Vincent’s Hospital Sydney is the nominated sponsor must have proof of support from the Chief Research Officer (CRO) (or delegate) prior to submission for governance review.

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
  • For Investigator initiated clinical trials, proof of institutional approval for St Vincent’s Hospital Sydney to act as the sponsor
  • 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
  • Proof of Research Operations Assessment Committee (ROAC) approval or exemption (for all Greater than Low Risk studies)
  • SVHS FPR number (if applicable, refer to Fees and Payments) 

Submission Requirements

ALL new site authorisation applications (single or multisite projects) for the St Vincent’s Hospital Sydney site:

  1. Must be submitted via REGIS
  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 SVHS SSA or LNRSSA 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 and the Victor Chang Cardiac Research Institute as well as 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

When submitting a new STE/SSA in REGIS an automated email is sent to each Head of Department (nominated in Part C of the STE/SSA form) for approval. The Research Office will receive the STE/SSA application only after all Heads of Department have provided approval.

It is essential that Heads of Department are made aware of the research project by the researcher before submitting the STE/SSA so that they are ready to action on the automated REGIS email when it is received.

Non-adherence to this process will result in delays in the review and authorisation of applications.

Please use the appropriate REGIS Quick Reference Guide for guidance. 

An alternative Head of Department approval is required if the listed investigator is also listed as a Head of Department. This alternative approval will be the individual’ s manager. If you cannot locate the alternative approval representative on REGIS, please contact the Research Office via email for further assistance. 

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 STE/SSA application. More information can be found on our Research Ethics – New Submissions page.