Welsh Government

Directory of Resources

A list of websites and downloadable documents developed to support research and development has been collated. Health and Care Research Wales does not take responsibility for any content provided by external organisations.

Revised model Clinical Trial Agreement

The 2011 revised model Clinical Trial Agreement (mCTA) is designed to be used without modification for industry-sponsored trials in patients in hospitals throughout the UK Health Service.

Four versions of the mCTA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.

Model Clinical Investigation Agreement

The model Clinical Investigation Agreement (mCIA) is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service.

2014 versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.

Clinical Research Organisation model Clinical Trial Agreement

The Contract Research Organisation model Clinical Trial Agreement (CRO mCTA) is a tripartite agreement between:

  • The pharmaceutical company sponsoring a trial
  • The contract research organisation (CRO) managing the trial
  • The NHS organisation where the trial takes place.

The CRO mCTA is based on the bipartite model Clinical Trial Agreement, used by pharmaceutical companies and NHS organisations. It is tailored to be used without modification for CRO-managed trials in patients in hospitals throughout the UK Health Service.

2011 versions of the CRO mCTA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.

Clinical Research Organisation model Clinical Investigation Agreement

The Contract Research Organisation model Clinical Investigation Agreement (CRO mCIA) is a tripartite agreement between:

  • The company sponsoring commercial research involving medical device(s)
  • The contract research organisation (CRO) managing the research
  • The NHS organisation where the research takes place.

The CRO mCIA is based on the bipartite model Clinical Investigation Agreement (mCIA), which is for use by NHS Trusts and the medical technology industry. This tripartite agreement is for use when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. This agreement is endorsed for use by the UK Health departments, National Institute for Health Research,  Association of British Healthcare Industries (ABHI), NHS Confederation, Medical Schools Council, NHS R&D Forum, Institute for Clinical Research and the UKCRC.

2014 versions of the CRO mCIA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.

Primary Care model Clinical Trial Agreement

The model Clinical Trial Agreement for pharmaceutical and biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and agreed by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly research-active general Practitioners, the British Medical Association, the Medical Protection Society and the UK health departments. The Health Research Authority supports the use of model agreements.

The 2013 Primary Care mCTA is designed to simplify and therefore speed up the process for signing off and initiating pharmaceutical and biopharmaceutical clinical trials involving patients in primary care. It is intended that the Primary Care mCTA is used routinely without modification by all pharmaceutical and biopharmaceutical industry sponsors of contract clinical research in which NHS patients are recruited in primary care.In such cases, no further review is necessary, saving money and time.