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

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 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): Study Identifiers as per table below Description & Rational of Contract Amendment Confirmation of HREC Approval (please attach) Confirmation of SVH Governance Approval 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 (MUST DO): Study Identifiers as per table below Description & Rational of Contract Amendment Confirmation of HREC Approval (please attach) Confirmation of SVH Governance Approval 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, 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	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