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Model Clinical Trial Agreement (mCTA) and Clinical Research Organisation mCTA (CRO-mCTA)

 

Model Clinical Trial Agreement (mCTA) and Clinical Research Organisation mCTA (CRO-mCTA)

In March 2020 a revised model Clinical Trial Agreement (mCTA) and Clinical Research Organisation mCTA (CRO-mCTA) were released on behalf of the four UK nations and the Association of the British Pharmaceutical Industry (ABPI).  Sponsors and CROs were asked to review and adopt the new templates at their earliest opportunity, with a six-month transition period allowed, after which earlier versions of the templates would not be accepted in new IRAS submissions. 

The Health Research Authority (HRA), jointly with the devolved administrations, have decided to extend this six-month transition period to the end of 2020, in recognition of the impact that the COVID-19 pandemic has had both on sponsor and CRO ability to focus on reviewing, feeding back and adopting the March 2020 templates, as well as on the ability of the four UK nations to effectively communicate the implications of the cut-off date.  We will keep this cut-off date for IRAS submissions of pre-March 2020 templates under review and further, more detailed, communication will follow. 

Please note that, whilst we have extended the time during which superseded templates will be accepted in IRAS, we are still strongly encouraging sponsors and CROs to adopt the current templates at their earliest opportunity.  Whilst we ask that sites are pragmatic when receiving earlier versions of the template, we have made industry aware that delays may arise from failure to adopt the 2020 versionsFor each study the appropriate template agreement is expected to be used without modification and we have been particularly clear that significant delays may arise from any proposed modifications to any templates or use of superseded templates.

Please also note that we anticipate the possibility of releasing a minor update to both templates (and others) in December 2020, to align the clauses as necessary with the legal situation following the end of the transition period for the UK exiting the EU.

This statement is endorsed by the national coordinating functions of the four UK nations and the ABPI.”


Feedback 

If you wish to provide feedback on the current templates that you would like considered for future versions, then please contact:
 
David Brownlee at ResearchContracts@innovations.hscni.net whereby I will raise directly with the “4 Nations Contracting Leads group”.

For assistance with queries relating to template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact Andrew Fox, Research Contracts Officer at HSC Innovations.  All correspondence should be sent to ResearchContracts@innovations.hscni.net for further information and assistance.