Skip to content
St Vincent's Centre for Applied Medical Research

Post Authorisation

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:

  • Amendments – Public Site
  • Amendments – Private Site
  • Changes to Research Personnel
  • Change in Personnel Amendment – Public Site
  • Change in Personnel Amendment – Private Site

Amendments – Public Site

Submitting a governance amendment for a study authorised to be conducted at the St Vincent’s Hospital Sydney site: 

  • All governance amendment submissions must be made via REGIS
  • All amendments must be reviewed by the St Vincent’s Hospital Sydney Research Governance Officer prior to implementation at the St Vincent’s Hospital Sydney site
  • Relevant HREC amendment approval must be obtained prior to SVHS RGO review and must be provided as part of the review
  • All other relevant governance implications affecting the site must be discussed with the relevant Head of Department and the St Vincent’s Hospital Sydney Research Governance Officer
  • Variations to study contracts may be required
  • It is the responsibility of the local St Vincent’s Hospital Principal Investigator (PI) to notify the relevant Head of Department and St Vincent’s Hospital Sydney Research Governance Officer of these changes as required
  • Only one governance amendment can be submitted for each HREC amendment approval letter (multiple HREC approvals merged into one governance amendment will be rejected) 

Amendments – Private Site

Submitting a governance amendment for a study authorised to be conducted at Private Sites (St Vincent’s Private Hospital, The Mater Hospital, Victor Chang Cardiac Research Institute):

  • All governance amendment submissions must be made via email to the St Vincent’s Hospital Sydney Research Office svhs.research@svha.org.au 
  • All amendments must be reviewed by the St Vincent’s Hospital Sydney Research Governance Officer prior to implementation at the St Vincent’s Private Hospital, The Mater Hospital and Victor Chang Cardiac Research Institute sites
  • Relevant HREC amendment approval must be obtained prior to St Vincent’s Hospital Sydney Research Governance Officer review and must be provided as part of the review
  • All other relevant governance implications affecting the site must be discussed with the relevant Head of Department and the St Vincent’s Hospital Sydney Research Governance Officer
  • Variations to study contracts may be required
  • It is the responsibility of the local St Vincent’s Hospital Principal Investigator to notify the relevant Head of Department and St Vincent’s Hospital Sydney Research Governance Officer of these changes as required
  • Only one governance amendment can be submitted for each HREC amendment approval letter (multiple HREC approvals merged into one governance amendment will be rejected)

Changes to Research Personnel

  • The approving HREC must be notified of changes to the Coordinating Principal Investigator (CPI) and/or site Principal Investigator (PI).  For all NSW/ACT sites this is done via REGIS
  • The appropriate Research Governance Officer must be notified of any other changes to site personnel (for example research assistants or associate investigators)

Change in Personnel Amendment – Public Site

Change in Personnel amendment for a study authorised to be conducted at the St Vincent’s Hospital Sydney site:

  • Change in Personnel requests must be submitted as STE general amendments via REGIS to allow for documents such as GCP certificates, CVs and proof of current ClinConnect clearance (where applicable) to be attached
  • Due to current lack of REGIS functionality, Change in Personnel Forms must not be submitted as “REGIS – Change in Personnel forms” and these will be rejected

Change in Personnel Amendment – Private Site

Change in Personnel amendment for a study authorised to be conducted at Private Hospital Sites (St Vincent’s Private Hospital, The Mater Hospital, Victor Chang Cardiac Research Institute):