If the investigator-initiated trial involves more than one site, the sponsoring institution will require a Clinical Trial Research Agreement (CTRA) with each participating site.
The CTRA will outline the obligations and responsibilities of both the sponsoring institution and the participating site with regards to:
For Australian sites, use Medicine Australia’s CRG CTRA template. In this template, the Collaborative Research Group (CRG) is the sponsoring institution, and the site is referred to as the institution.
Note: The Medicines Australia CRG CTRA template is one of five CTRA templates developed by Medicines Australia together with the NSW, QLD, VIC, SA and Tasmania Health Departments (the South Eastern Border States – SEBS Committee). SEBS approval is required to change the content or clauses of the CTRA templates.
If an investigator-initiated trial receives support from a commercial company (e.g. provision of investigational product) or other service, an agreement will need to be in place before that support is provided. Usually, commercial companies will want to use their own Agreement template but there may be occasions when both parties agree to use the sponsoring organisation’s Service Agreement template. Seek advice from the sponsoring organisation’s legal department when beginning contract negotiations.
NHMRC grant-funded research that involves collaboration between two or more sites must have a NHMRC Multi-Institutional Agreement (MIA) in place. The MIA is an NHMRC template agreement that details how the NHMRC funds will flow to the parties over the funding period and include details on who the Administering Institution is, intellectual property ownership, publication rights, insurance and indemnity obligations etc. Please contact your local grants office for more information about the MIA's and NHMRC grant funded research.
If a health service organisation owns material/data that is being sent to another organisation that is not a participating trial site or the sponsoring institution, then a Material Transfer Agreement (MTA) will be required between the two organisations. Examples include sending samples to an external laboratory for analysis or sending data to an external provider contracted to undertake data management or statistical analysis. The health service that owns the material/data will usually provide their own MTA template.
Examples of MTA templates include:
MCRI: Material Transfer Agreement - MCRI Receiving (for use when an organisation is receiving material/data)
MCRI: Material Transfer Agreement - MCRI Supplying (for use when an organisation is the owner/custodian of the material/data)
If an external party requests access to data collected as part of an investigator-initiated trial, a Data Transfer Agreement (DTA) will need to be executed by the individual/third party requesting access to the data (Data Requestor) and the sponsoring institution prior to the transfer of data. The DTA sets out the obligations of the Data Requester in relation to storage and use of the data. It describes the terms and conditions which must be agreed to prior to the release of data, including obligations to:
The DTA also provides that the sponsoring institution retains all ownership and Intellectual Property rights to the data and the Data Requester is granted a limited license to use the data for their specific project. The recipient is required to inform the sponsoring institution of any new Intellectual Property Rights developed from use of the data, and the parties will then negotiate their respective ownership rights.
Examples of DTA templates include:
If confidential information will be shared with or received from an external organisation, a Confidentiality Agreement (otherwise known as a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) will be required.
The agreement binds the external organisation/individual to maintaining the confidential nature of the information. They cannot use the information for any other purposes than what is specified.
It is important to check with the health service/organisation that owns the data to establish who can authorise CDAs. Usually the Sponsor-Investigator/Principal Investigator is not authorised to sign. Instead CDAs are usually signed by the legal office.