For all clinical trials and clinical investigations (including CTIMPs, device studies, etc.), it is expected that a signed agreement between the sponsor and the host organisation will be in place before the research commences at the site.
For studies under HRA Approval, the HRA Initial Assessment Letter (and HRA Approval letter) will specify the appropriate agreement for each site type in a study. The document might be the Statement of Activities and Schedule of Events, an unmodified model agreement (e.g. mCTA) or another document provided by the sponsor.
Where it is expected that there be an agreement between the sponsor and the site (including all commercially sponsored studies), it is strongly recommended that an unmodified model agreement is used. These agreements should be used as set out in their accompanying guidance. Use of the unmodified model agreement simplifies and speeds up the study setup process. The UK Clinical Research Collaborations (UKCRC) model agreements have been negotiated with English law and governance arrangements at their core and modified versions are available for use under the legal systems and administrative arrangements of Scotland, Wales and Northern Ireland. Using a modified model agreement, or an agreement not based on a model template is possible, but the sponsor should be aware of potential difficulties that can often be encountered such as prolonged negotiation periods, and the risk that the study may not be able to go ahead if certain terms cannot be agreed with participating organisations.
Where a template based on the model agreement is submitted but includes modifications, the sponsor should explain the rationale.
There are several different model agreements, and you should use the one that is most appropriate for your study type and sponsorship arrangements. For more information visit the IRAS website.
Will you be seeking HRA Approval?
If you will be seeking HRA Approval for your study, you may also find it useful to refer to the HRA assessment criteria and standards document as this includes considerations around the use of model agreements. You can find the document on our dedicated HRA Approval page.