Contracts and agreements

The Research Governance Office can provide assistance with research-related agreements for any research that involves SCHN.

If your project involves:

the transfer of data, materials or funds,
providing a service/s, or a service is required,
collaborating with colleagues from another institution,

then an agreement is required.

Please contact the Research Governance Office to assist in determining the most appropriate agreement for your purpose.

Contact Research Governance

When contacting the Research Governance Office via email for assistance in determining which agreement/s will be most appropriate for your research project, ensure the email contains the following information:

Whether the Principal Investigator is an employee of SCHN.
Whether Ethics approval has been obtained. Please provide the ETH Reference Number.
Whether Site Specific Authorisation has been obtained. Please provide the STE Reference Number.
The name of the organisation funding the research project.
Whether the project is a collaboration with other organisations. If so, please provide details of their involvement in the project.
Is there an international organisation involved?
What is SCHN’s contribution to the project?
Is there SCHN Background Intellectual Property to protect?
Do you anticipate that further Intellectual Property will be created through the course of the research?

Types of agreements

Requests for SCHN agreement templates, reviews, negotiations and signing of the below mentioned Agreements must be submitted to the Research Governance Office via email.

Clinical Trial Research Agreement

Clinical Trial Research Agreements (CTRA) are the nationally accepted standard contracts used for clinical trials (both collaborative and commercially sponsored).

The SCHN Research Governance Office have developed a CTRA Cheat Sheet to assist study teams review the draft CTRA before submitting to REGIS. The cheat sheet should be used to liaise with the sponsor for any changes required prior to the research governance application submission.

Please visit the Medicines Australia website for further information and CTRA templates.

Upload an unsigned Microsoft Word version of the CTRA in Part F of the Research Governance SSA Form. The reviewing Research Governance Officer will advise when the signing process can begin.

Form of Indemnity

A Form of Indemnity (FoI) is put in place by an entity or organisation that will conduct or participate in a clinical trial. The FoI is a legal insurance document that will protect (or indemnify) the parties involved from accountabilities that may arise from a clinical trial.

Please visit the Medicines Australia website for more information.

Upload an unsigned Microsoft Word version of the FoI in Part F of your Research Governance SSA Form. The reviewing Research Governance Officer will advise when the signing process can begin.

Research Grant/Funding Agreements

A Research Grant or Funding Agreement is put in place when a sum of money is provided by an entity or organisation to a person or institution to assist with the conduct of their research. Sometimes, there are responsibilities that researcher/s must comply with in order to accept the incoming grants or funds.

If SCHN is included in a multi-institutional research grant application, it must be named as a participating institution in the Multi-Institutional Agreement (MIA) to ensure alignment, transparency, and clear delineation of roles and responsibilities.

Confidential Disclosure Agreement

Confidential Disclosure Agreements (CDA), also referred to as Non-Disclosure Agreements, are often required by pharmaceutical companies who wish to disclose confidential information (usually in the form of a Protocol) to a particular SCHN investigator to assess if they will be able to participate in a proposed study. CDAs are also required when external companies wish to receive confidential information from SCHN.

SCHN accept the templates of external companies; although, SCHN can provide our template if the other company does not have one.

We recommend using our CDA template when SCHN confidential information is being sent to other companies.

Sydney Children's Hospitals Network details

SCHN legal name for contracts and ABN

The Children's Hospital at Westmead (CHW)

The Sydney Children's Hospitals Network (Randwick and Westmead)(incorporating the Royal Alexandra Hospital for Children) t/as The Children’s Hospital at Westmead (CHW) Cnr Hawkesbury Rd and Hainsworth Street Westmead, ABN 53 188 579 090

The Sydney Children’s Hospital, Randwick (SCH)

The Sydney Children's Hospitals Network (Randwick and Westmead)(incorporating the Royal Alexandra Hospital for Children) t/as Sydney Children’s Hospital (SCH) High Street Randwick NSW, ABN 53 188 579 090

The Sydney Children’s Hospitals Network (SCHN)

The Sydney Children's Hospitals Network (Randwick and Westmead) (incorporating the Royal Alexandra Hospital for Children), ABN 53 188 579 090

SCHN electronic signature guideline

SCHN Research Governance uses DocuSign for execution of all research related agreements.

The reviewing officer will advise and provide instructions for SCHN to initiate the signing process when ready.

Please refer to the SCHN contract execution guide for further information.

USA Office of Human Research Protection and research at SCHN

SCHN is registered with the United States of America (USA) Office for Human Research Protection (OHRP) in two ways:

As an organisation with an accredited and recognised Institutional Review Board (IRB), in essence, the HREC and
As a signatory to the Federal Wide Assurance (FWA) for the protection of human subjects

Please refer to the details in our SCHN HREC IRB and FWA Registration Details, if your project:

Is an international multi-site project
Originated in the USA
Is supported or funded by a USA-based agency or organisation