Clinical Trial Agreements
The Sponsor-Investigator, sponsoring institution and site Principal Investigators of participating sites, should ensure that the appropriate agreements are in place before undertaking work with partners on the management of the trial. All parties, or their appropriate representative(s), should sign off on agreements to ensure a clear and accepted understanding of assigned responsibilities.
According to the Australian Code for the Responsible Conduct of Research (2018), agreements should follow the general principles of the Code,
“including integrity, honesty and a commitment to excellence.
The agreement should be in writing. It must cover intellectual property, confidentiality and copyright issues; sharing commercial returns, responsibility for ethics and safety clearances; and reporting to appropriate agencies. It should address the protocols to be followed by the partners when disseminating the research outcomes, and the management of primary research materials and research data.”
Why it is important to have a formal agreement
- Set out the binding terms governing the relationship between the parties.
- Set out the rights and obligations of each party and is a tool that can be used if things go wrong.
- Protect the interests of the sponsoring institution
- Helps mitigate risks, limit liability and make sure adequate insurance is in place
- Protects the sponsoring institution’s assets and intellectual property
- Ensures the sponsoring institution complies with obligations to funders and other collaborators
- Protect the interests of the researchers involved
- Sets out expectations
- Protects them from being personally liable if things go wrong
- Protects their intellectual property rights, including publication rights and right to use the results for research purposes
- Protect the interests of participants or other individuals involved in the trial by setting out confidentiality obligations and making sure parties comply with relevant privacy laws.
Sponsoring Institution/Sponsor-Investigator Partnerships
During the trial lifecycle, the sponsoring institution and Sponsor-Investigator will need to arrange agreements with various partners. Agreement templates are available and depending on the situation, these may be provided by the sponsoring institution, the service provider, funder or another third party.
Examples of partners that will require an agreement are listed below. Always check with the sponsoring institution’s legal office if they have an Agreement template they would like you to use.
- External trial sites - a Clinical Trial Research Agreement (CTRA) will be required between the sponsoring institution and each trial site.
- External funders - a funding agreement will be required. In most cases, the funder will use their own Agreement template. Examples of funders include NHMRC and pharmaceutical companies if providing investigational product (IP).
- External service providers – a Service Agreement will be required. Services that may be contracted to external providers include transcription/translation services, laboratory tests, courier services, medical imaging, trial monitoring, statistical analyses, data management, medical writing and archiving. In most cases, the service provider will use their own Service Agreement template.
- Investigational product (IP) manufacturer if manufacturing IP or placebo for your trial. In most cases, the manufacturer will use their Service Agreement template.
- External parties seeking to re-use the data or materials collected as part of the trial – the sponsoring institution will require either a Data Transfer Agreement (DTA) (for data requests) or Material Transfer Agreement (data and/or material requests).
- Potential sites (before site selection) - the sponsoring institution may decide to enter into a Confidentiality Agreement before a potential site is selected and then enter a CTRA if both parties decide to go ahead.
- Collaborating institution/party – a Research Collaborative Agreement (RCA) will be required if two or more institutions/parties are involved in developing the trial protocol or sharing other Sponsor responsibilities. The RCA would set out the terms of the collaboration.
- Data Safety Monitoring Board (DSMB) members – a Confidentiality Agreement may be required, depending on the sponsoring institution’s local requirements.
Additional agreements will be required when conducting investigator-initiated trials with sites based overseas and/or using external service providers based outside Australia. See AGREEMENTS with OVERSEAS PARTIES.
For information about the different types of agreements and to understand which agreement template is suitable for your needs, see TYPES of AGREEMENTS.
Participating Trial Sites
Before a trial starts, the participating trial site will need to ensure they have a fully executed Clinical Trial Research Agreement (CTRA) with the sponsoring institution. The CTRA must be submitted to the Research Governance Office (RGO) at the proposed trial site by the Site Principal Investigator (PI) as part of an application for site-specific assessment (SSA).
To learn more about the different types of agreements and where to access templates, see Types of Clinical Trial Agreements