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Regulatory documents

Contracts, Agreements, Insurance and Indemnity

When research involves a party external to NSLHD, documentation that relates to the management, insurance, indemnity, financial support and sponsorship of the research may be required.

The NSLHD Research Governance Officers (RGO) are available to offer guidance to investigators to ensure the correct regulatory documents are used.

The most commonly used regulatory documents are: 

  • Confidentiality Disclosure Agreements (CDAs)
  • Clinical Trial Research Agreements (CTRAs)
  • Form of Indemnity (FoI)
  • Clinical Trials Insurance
  • Material Transfer Agreements (MTAs)
  • Therapeutic Goods Administration Clinical Trial Notification (CTN)

 

Confidential Disclosure Agreement (CDAs) also known as Non-Disclosure Agreements (NDA).

CDAs are used to impose obligations on a party (often known as the 'recipient') that receives information from another party (often known as the 'disclosing party') who considers such information or materials to be confidential.

CDA parties promise to limit the use of the information as detailed in the agreement.

For example, a drug company proposes to engage NSLHD to conduct a clinical trial. Prior to discussing trial details the drug company may request a CDA is signed by NSLHD in order to protect the idea or concept behind the research.
A CDA is a legally binding contract and the Chief Executive is the only person who can sign CDAs for NSLHD.

CDA submission instructions:

  • Please ensure the correct institution details for NSLHD are included. These details can be found PDF icon here.
  • Please email a word version of the CDA to NSLHD-Resear[email protected]
  • Please allow a minimum of 14 days for review and return of the CDA.

 

Research Agreements

All clinical trials with an external sponsor must have a written agreement in place, to clarify the obligations, responsibilities and rights of the parties involved in the research. Please be advised that there are several different research agreement templates approved for use within a Public Health Organisation (PHO) and the Research Governance team strongly recommend the use of one of these. The use of non-standard agreements will require further review and could result in delays to authorisation.  

Clinical Trial Research Agreement (CTRA)

Five CTRA templates have been approved for use in NSW PHOs and can be found here External Link. Please contact the RGO for guidance on which template to use for your research.

Please note that any clauses included at Schedule 4 or 7 must be approved by the SEBS Committee and evidence of SEBS approval must be provided with the application.

Submission instructions:

  • Researchers are strongly encouraged to submit the CTRA in draft (without signatures) to the RGO for review prior to governance submission. Please email the CTRA to [email protected], attention RGO.
  • Please ensure the correct institution details for NSLHD are included on page 1. These details can be found here.
  • Please be advised changes cannot be made to the standard clauses (pages 2-17).
  • Please include the following wording in Schedule 2, 'payments':

All HREC and/or Research Governance fees will be paid by sponsor (or XXXXX) upon receipt of invoice. Costs can be found on the NSLHD Research Office website.

Sponsor (or XXXXX) will provide a Purchase Order (PO) number for inclusion on the invoice.

  • Once reviewed and approved by the RGO, CTRAs must be signed by the Sponsor and Principal Investigator before submitting for review with the governance application through REGIS.
  • Fully executed CTRAs will be signed and returned with project authorisation via REGIS.

 

Clinical Investigation Research Agreement (CIRA)

A device trial is known as a 'clinical investigation' rather than a 'clinical trial'. The Medical Technology Association of Australia (MTAA) has developed a Clinical Investigation Research Agreements (CIRAs) and a Form of Indemnity (FoI) for use in commercially sponsored studies of medical technology. Please click here for further information on regulatory documents for use when conducting device trials including the MTAA Standard Clinical Research Investigation Agreement (CIRA) template.

 

Investigator Initiated Research

When Investigator Initiated research involves a party external to NSLHD, an agreement may be required.

The NSLHD Research Office strongly recommends the use of one of the following templates for investigator initiated trials:

 

Submission instructions:

  • Researchers must submit the Research Agreement in draft (without signatures) to the RGO for review prior to SSA submission. Please email the agreement to [email protected], attention RGO.
  • Please ensure the correct institution details for NSLHD are included on page 1. These details can be found PDF icon here.
  • Please include the following wording in Schedule 2, 'payments':

All HREC and/or Research Governance fees will be paid by XXXXX upon receipt of invoice. Costs can be found on the NSLHD Research Office website.

For external payees, where an invoice will be issued, a Purchase Order (PO) number must be provided inclusion on the invoice.

  • Once reviewed and approved by the RGO, CTRAs must be signed by the external party and Principal Investigator before submitting the agreement for review through REGIS. 
  • Fully executed research agreements will be signed and returned with project authorisation via REGIS.

 

Material Transfer Agreements (MTA)

If your research involves a transfer of data, materials or samples (such as cell lines, blood, tissue, CT and MRI scans and other clinical data) from NSLHD to an external site and does not require a CTRA or other collaboration agreement a MTA may  be required.

It is strongly recommended that you contact the Research Office to ascertain this requirement.

The execution of a MTA incurs a fee. Please see our fee policy for details.

Submission instructions:

  • The NSLHD MTA template can be found Word icon here.
  • Please note that only the highlighted text should be completed and changes should not be made to the standard terms and conditions.

Please note that any requested changes to the standard terms and conditions will require external review, will add additional delays to the review and may incur additional fees.

  • It is strongly recommended that the draft MTA (without signatures) is submitted to the RGO for review prior to SSA submission. Please email the MTA to [email protected], attention RGO.

 

Indemnity

For all commercially sponsored clinical trials a Medicines Australia Form of Indemnity External Link must be provided by the commercial sponsor on the Medicines Australia Form of Indemnity for Clinical Trials. The MTAA has forms of indemnity External Link available for commercially sponsored clinical investigations.

There are two forms of indemnity, standard and HREC only, available for use.

 

Form of Indemnity – HREC Review only

This form is to be submitted with the ethics application to NSLHD HREC when the ethics application is for a project that will be conducted outside of NSLHD. That is, NSLHD has no participating sites. 

Submission instructions:

  • Please ensure the correct institution details for NSLHD are included on page 1. These details can be found PDF icon here.
  • The Form of Indemnity – HREC Review only, must be signed by the sponsor before submitting the form with the ethics application through REGIS. 
  • The form will be executed by NSLHD and returned via Regis with project approval.

 

Form of Indemnity - Standard

This form is to be submitted with the governance application when NSLHD is providing premises for the conduct of the study and HREC Review, or is providing premises only.

 

Insurance

For all commercially sponsored clinical trials, an Insurance Certificate must be submitted with the governance application. Please refer to NSW MoH Policy PDF icon Clinical Trials – Insurance and Indemnity PD2011_006 External Link, section 2.2.2 for further information on insurance requirements.

 

Therapeutic Goods Administration (TGA) Clinical Trial Notification

The Australian clinical trial sponsor must notify the TGA of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good prior to commencement of the use. The notification form must be submitted online and accompanied by the relevant fee. Please click here External Link  for further information.

For investigator initiated research, where NSLHD will assume the role of sponsor, the CTN will be lodged by the Research Office, however it is the responsibility of the investigator to provide the information required for the CTN and pay the associated fee incurred by the TGA. Please complete the NSLHD eCTN summary, found here, and submit this to the Research Office with your governance application.