Model Contracts
This guidance provides an overview of the model contracts that have been created by the Health Research Authority (HRA). It is recommended that these contracts are used unmodified by study sponsors when they contract with sites to deliver studies.
Types of Contracts
Model Clinical Trial Agreements (mCTA) - with the sponsor or with the Contract Research Organisation (CRO-mCTA). Guidance on how to use these can be found here.
Commercial Primary Care Model Clinical Trial Agreement (PC-mCTA). These can be Bi-partite Primary Care mCTA or Tri-partite Primary Care mCTAs. Guidance on how to use these can be found here.
Model Clinical Investigation Agreement (mCIA) and Clinical Research Organisation model clinical Investigator Agreement (CRO-mCIA).
Model Non-Interventional Study Agreement (mNISA) - with the sponsor or with the Clinical Research Organisation (CRO-mNISA).
UK template Hub and Spoke Agreements. These are for use between Lead Trial sites and Other Trial Sites, where a Hub and Spoke delivery model is proposed.
Model agreements for Participant Identification Centres (mC-PICA).
Model Confidentiality Disclosure Agreements (mCDA). Guidance of how to use these can be found here, and more information on mCDAs can be found here.
Templates for these model agreements as well as additional guidance can be found here.
What are Contracts Used for?
It is recommended that sponsors use these model contracts when they contract sites to deliver their studies.
Sponsors should use these contracts unmodified. If they do modify them, this should be highlighted.
Why is this Important?
Use of the model contracts provides sites with reassurance that all relevant and important information is included within their contract with the sponsor or CRO.
You can use the template contracts to support your contract review process, to check that nothing has been modified.