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Clinical Research Organisation model Clinical Trial Agreement
The Contract Research Organisation model Clinical Trial Agreement (CRO mCTA) is a tripartite agreement between a pharmaceutical company sponsoring a trial, the contract research organisation (CRO) managing it and the NHS organisation where the trial takes place. It is based on the bipartite model
Clinical Trial Agreement used by pharmaceutical companies and NHS organisation, but is tailored to trials managed by CROs. It is designed to be used without modification for CRO-managed trials in patients in NHS hospitals throughout the UK.
Four versions of the CRO mCTA have been developed to ensure compliance with the law and to reflect regional instituional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.
Available downloads:
- Guidance notes
- CRO mCTA England
- CRO mCTA Northern Ireland
- CRO mCTA Scotland
- CRO mCTA Wales
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