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St Vincent's Centre for Applied Medical Research

Research Contracts and Agreements

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:

  • Agreement Types
  • Legal Entity Details
  • Contact for Notices
  • Contract Execution Method
  • Standard Clinical Trials Research Agreements
  • Special Conditions
  • Other Agreements
  • Contract Submission Requirements (Public & Private Sites)

Agreement Types

The St Vincent’s Hospital Sydney Research Office routinely reviews a variety of research agreements related to specific human research studies. These include but are 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 or variations to the above

To assist with efficient processing please use this email guide when submitting contracts for review.

Please use the appropriate legal entity details (outlined below) for your agreement.

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: (Mater Hospital Sydney)St Vincent’s Private Hospitals Ltd (trading as the Mater Hospital Sydney) with its registered address at Level 22, 100 William Street, Woolloomooloo NSW 2011
Site Address:25 Rocklands Road, North Sydney, NSW 2060
ABN61 083 645 505
Legal Entity Name:Victor Chang Cardiac Research Institute Limited
Site Address:405 Liverpool Street, Darlinghurst, NSW 2010
ABN61 068 363 235

Contact for Notices

Where applicable, “Contact for Notices” should list the name and contact details of a person close to the study (not the Research Office or Research Officers). 

Contract Execution Method

St Vincent’s Hospital Research Office supports the signing of contracts via the following methods – please clarify your preferred method of contract execution at the time of submission:

Standard Clinical Trials 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.

Special Conditions

St Vincent’s Hospital Sydney 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. 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 website.

Other Agreements

The need for agreements is usually identified as part of St Vincent’s Hospital Sydney Research Governance Officer review and appropriate templates will be provided at that time.

Contract Submission Requirements

See below tables for more information regarding St Vincent’s Hospital Sydney Research Office 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 that are not study specific)

Public Sites

 
Document TypeSubmission Pathway & FormatSubmission Requirements
NewVia REGIS with initial ETH or STE application submission. Microsoft Word. A clear request must be made in the cover letter if contract execution is required via e-signature loop DocuSign/Adobe Sign
AmendmentVia email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email (ESSENTIAL): 1. Study Identifiers as per EMAIL TEMPLATE below 2. Description & Rational of Contract Amendment 3. Confirmation of HREC Amendment Approval in Reference to this Contract Amendment (please attach) 4. Confirmation of SVH Governance Amendment Approval in Reference to this Contract Amendment (please attach) 5. Statement on signature pathway (e-signature or digital) 6. FPR number (if appropriate)
PRE-ETH/STE Via email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email: 1. Study Identifiers as available 2. Names of Parties involved 3. Description of Collaboration/SVH Research Group involved/potential studies 4. Statement on signature pathway (e-signature or digital) 5. FPR number (if appropriate)
Miscellaneous Via email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email: 1. Study Identifiers as available 2. Names of Parties involved 3. Description of Collaboration/SVH Research Groups involved/potential studies 4. Statement on signature pathway (e-signature or digital 5. FPR number (if appropriate)

Private Sites
Document TypeSubmission Pathway & FormatSubmission Requirements
NewVia email with initial ETH or SSA application submission to svhs.research@svha.org.au. Microsoft Word. A clear request must be made in the cover letter if contract execution is required via e-signature loop DocuSign/Adobe Sign
AmendmentVia email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email (ESSENTIAL): 1. Study Identifiers as per EMAIL TEMPLATE below 2. Description & Rational of Contract Amendment 3. Confirmation of HREC Amendment Approval in Reference to this Contract Amendment (please attach) 4. Confirmation of SVH Governance Amendment Approval in Reference to this Contract Amendment (please attach) 5. Statement on signature pathway (e-signature or digital) 6. FPR number (if appropriate)
PRE-ETH/STE Via email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email: 1. Study Identifiers as available 2. Names of Parties involved 3. Description of Collaboration/SVH Research Group involved/potential studies 4. Statement on signature pathway (e-signature or digital) 5. FPR number (if appropriate)
Miscellaneous Via email to svhs.research@svha.org.au. Microsoft Word. Include the following information in the body of the email: 1. Study Identifiers as available 2. Names of Parties involved 3. Description of Collaboration/SVH Research Groups involved/potential studies 4. Statement on signature pathway (e-signature or digital 5. FPR number (if appropriate)