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

Submitting contracts for review:

  • Contracts must be submitted to the Research Office either:
  • Contracts should be submitted where possible in MS word format to enable initial review.
  • Please ensure that the correct legal entity details of the organisations whose research governance falls under the jurisdiction of the St Vincent’s Hospital Research Office are inserted (see below).
  • The purpose of the ‘Contact for Notices’ is to specify the contact point when one party has to notify the other party of something arising out of the contract. This should be someone who is well across the study such as the trial coordinator. A generic email address can be used if it is always manned. In most cases, Research Office staff are not appropriate points of contact.
  • Note that governance review of a submission may identify the need for a contract to govern the conduct of the study and the reviewing Research Officer will advise accordingly.

Contract Execution:

  • The Research Office is unable to facilitate wet ink signatures
  • Signature methods supported include:
    • Adobe Digital Signature (Adobe Pro DC e-sign)
    • DocuSign eSignature platform
    • Adobe Sign eSignature platform
  • If sign off is required via Adobe Sign or DocuSign eSignature platforms this must be clearly stated on the cover letter or submission email/REGIS amendment application form.
  • If no e-signature preference is stated on either the cover letter or submission email/REGIS amendment application form, all contracts will be executed via Adobe Digital Signature (Adobe Pro DC e-sign)

St Vincent’s Hospital Research Office DocuSign and Adobe Sign Instructions

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