Contract 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

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 DocuSign and Adobe Sign Instructions

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 (MUST DO):

  1. Study Identifiers as per table below
  2. Description & Rational of Contract Amendment
  3. Confirmation of HREC Approval (please attach)
  4. Confirmation of SVH Governance Approval
  5. 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:

  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)

Miscellaneous

M/S Word

Via email to svhs.research@svha.org.au

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

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 (MUST DO):

  1. Study Identifiers as per table below
  2. Description & Rational of Contract Amendment
  3. Confirmation of HREC Approval (please attach)
  4. Confirmation of SVH Governance Approval
  5. 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:

  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

Miscellaneous

M/S Word

Via email to svhs.research@svha.org.au

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

EMAIL TEMPLATE:

Dear Research Office, Dear HREC, Dear RGO (Please select one)

SVH Ref:

PID:

ETH:

HREC reference number:

STE:

Project title:

PI:

Site:

Description/Rational of Submission:

HREC Approval:

SVH Governance Approval:

Digital Adobe or e-signature DocuSign/AdobeSign:

Other 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 Hospital Sydney Limited, trading as St Joseph’s Hospital

Site Address:

2A Normanby Road, Auburn, NSW 2144

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

Prof Terry Campbell

Position

St Vincent’s Hospital Sydney Director of Research

Contact Phone

0283824960

Contact Email

SVHS.research@svha.org.au