Contract and TGA Submission Guidance You are here:HomeResearch & EducationResearch OfficeContract and TGA Submission Guidance Contract and TGA/eCTN Submission Guidance The St Vincent’s Hospital routinely reviews a variety of research agreements related to specific human research studies including but not limited to: Confidentiality Agreements (CDAs or NDAs) Clinical Trial Research Agreements (CTRAS, Medicines Australia CTRA templates& MTAA CTRA templates) HREC review only forms of indemnity (Medicines Australia templates only) Standard forms of indemnity (Medicines Australia templates only) Data Transfer or Sharing Agreements (DTAs, DSAs) Material Transfer Agreements (MTAs) Research Collaboration Agreements Amendments to the above Where applicable, "Contact for Notices" should list the name and contact details of a person close to the study (not the Director of Research, Research Office Manager or Research Officers). St Vincent’s Hospital Research Office supports the signing of contracts via DocuSign or Adobe Sign e-signature platforms as well as standard Adobe digital signature. Please clarify your preferred method of contract execution at the time of submission Please click here for St Vincent’s Hospital Research Office Electronic Signature Guidance SVH Contract Submission Requirements for: New ETH/STE/SSA Study-Specific Contracts (e.g. CTRAs, Standard Indemnity, HREC Review Only Indemnity Amendments to Study-Specific Contracts (e.g Variations, Amendments, Addenda) PRE-ETH/STE/SSA Contracts (e.g CDAs) Miscellaneous Contracts (e.g NHMRC Multi-Institutional Funding Agreements not study specific) PUBLIC SITES: Document Type Format Submission Pathway Submission Requirements New M/S Word Via REGIS with initial ETH or STE application submission A clear request must be made in the cover letter if contract execution is required via e-signature loop DocuSign/Adobe Sign Amendment M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email (ESSENTIAL): Study Identifiers as per EMAIL TEMPLATE below Description & Rational of Contract Amendment Confirmation of HREC Amendment Approval in Reference to this Contract Amendment (please attach) Confirmation of SVH Governance Amendment Approval in Reference to this Contract Amendment (please attach) Statement on signature pathway (e-signature or digital) PRE-ETH/STE M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email: Study Identifiers as available Names of Parties involved Description of Collaboration/SVH Research Group involved/potential studies Statement on signature pathway (e-signature or digital) Miscellaneous M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email: Study Identifiers as available Names of Parties involved Description of Collaboration/SVH Research Groups involved/potential studies Statement on signature pathway (e-signature or digital PRIVATE SITES: Document Type Format Submission Pathway Submission Requirements New M/S Word Via email with initial ETH or SSA application submission to svhs.research@svha.org.au A clear request must be made in the cover letter if contract execution is required via e-signature loop DocuSign/Adobe Sign Amendment M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email (ESSENTIAL): Study Identifiers as per EMAIL TEMPLATE below Description & Rational of Contract Amendment Confirmation of HREC Amendment Approval in Reference to this Contract Amendment (please attach) Confirmation of SVH Governance Amendment Approval in Reference to this Contract Amendment (please attach) Statement on signature pathway (e-signature or digital) PRE-ETH/SSA M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email: Study Identifiers as available Names of Parties involved Description of Collaboration/SVH Research Group involved/potential studies Statement on signature pathway (e-signature or digital Miscellaneous M/S Word Via email to svhs.research@svha.org.au Include the following information in the body of the email: Study Identifiers as available Names of Parties involved Description of Collaboration/SVH Research Groups involved/potential studies Statement on signature pathway (e-signature or digital EMAIL TEMPLATE: Dear Research Office, SVH Ref: PID: ETH: HREC reference number: STE: Project title: PI: Site: Description/Rational of Submission (Please provide a detailed description of the reason for the amendment submissions and outline any implications for the site): HREC Approval of Amendment (Please provide HREC amendment approval in relation to this contract amendment): SVH Governance Approval of Amendment (Please provide SVH governance amendment approval in relation to this contract amendment): Digital Adobe or e-signature Pathway (e.g. DocuSign/AdobeSign) (Please confirm the preferred sign off pathway): Other Relevant Site Specific Information (Please advise of any important and site relevant information): Legal Entity Details Legal Entity Name: St Vincent’s Hospital Sydney Limited Site Address: 390 Victoria Street, Darlinghurst, NSW 2010 ABN: 77 054 038 872 Legal Entity Name: St Vincent’s Private Hospital Sydney as conducted by the Congregation of the Religious Sisters of Charity Site Address: 406 Victoria Street, Darlinghurst, NSW 2010 ABN: 99 269 630 262 Legal Entity Name: St Vincent’s Private Hospitals Ltd Site Address: 25 Rocklands Road, North Sydney, NSW 2060 ABN 61 083 645 505 Legal Entity Name: Victor Chang Cardiac Research Institute Limited Site Address: 405 Liverpool Street, Darlinghurst, NSW 2010 ABN: 61 068 363 235 TGA – Trial Site Details for eCTN: If it has been determined by the reviewing HREC that an eCTN (electronic Clinical Trial Notification) must be submitted to the Therapeutic Goods Administration (TGA), the following site specific eCTN information must be used by the Sponsor: Site Details Site Name St Vincent’s Public Hospital Sydney Site Physical Location 390 Victoria Street, Darlinghurst State/ Territory NSW Expected Site Start Date XX/XX/XXX Principal Investigator Details Name SVH Principal Investigator Name Contact Phone Number 028382xxxx Contact Email …..@svha.org.au Human Research Ethics Committee (HREC) Details (IF SVH is the REVIEWING HREC) HREC Name St Vincent’s Hospital Sydney HREC HREC Code EC00140 HREC Contact Office Research Office Position Research Office Manager Contact Phone 0283824960 Contact Email SVHS.research@svha.org.au Approving Authority Details Name of Approving Authority St Vincent’s Hospital Sydney Limited Approving Authority Contact Officer A/Prof Philip Cunningham Position St Vincent’s Hospital Sydney Interim Executive Director of Research Contact Phone 0283824960 Contact Email SVHS.research@svha.org.au