Transcription of mCTA Guidance 2011 - UKCRC
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mCTA Guidance 2011 - UKCRC
Guidance for the model Clinical Trial Agreement for Pharmaceutical and Biopharmaceutical Industry sponsored research in NHS Hospitals (mCTA, 2011 version) mCTA Guidance , 2011 version 2 Introduction Background to the development of the model Clinical Trial Agreement Following the publication of the DH/ABPI model Clinical Trial Agreement (mCTA) for pharmaceutical research in 2003, most pharmaceutical and biopharmaceutical companies operating in the UK adopted it as the core template for their CTA. To address particular corporate needs or concerns, or the circumstances of specific studies, in the early years after its adoption, pharmaceutical companies and NHS hospitals incorporated a variety of modifications into the terms of the model agreement s first version.
mCTA Guidance, 2011 version 3 costs arising from them. The mCTA now contains provisions that require such notifications to be made and discussions about costs and reimbursements to take place.
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