Finally, although the new models comply with Article 28 of the GDPR, the relevant obligations of the processor are only expressly stated for the participating organisation, but not for the CRO, which is also a processor under the CRO-mCTA, thus leaving a question mark on how or where the relationship between the controller and the processor and the CRO should be documented. The HRA welcomed two new treaty proposals that will facilitate research and development of medicine and the development of life-changing vaccines in different parts of the UK. The most fundamental change is that the revised models apply to health services in England, Northern Ireland, Scotland and Wales and replace the 2011 national versions. Therefore, a single standard contract for commercial clinical trials throughout Britain will be possible, which will not allow the same study to be managed unnecessarily throughout Britain. ABPI commented that «the new mCTA enjoys broad support for life sciences leaders within government across Britain for the potential it has to accelerate innovative research and development.» These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; They replace the national versions of 2011. The accompanying guidance notes provide more general information, an overview of changes from the 2011 versions, and other information on how the models should be used and under what circumstances. In addition to introducing the new models, IRAS is putting in place formal feedback mechanisms from NHS organisations on the content of the models and their use by sponsors and clinical research organisations. ABPI has also put in place mechanisms to obtain feedback from industry. The aim is to update, where appropriate, the models to reflect changes in the regulatory and wider clinical research environment and to ensure that the knowledge gained is integrated into counselling, training and other means of communication.
The Clinical Trial Agreement model for primary care research (Primary Care mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of very active GPs, the British Medical Association, the Medical Protection Society and the UK Health Services. The Health Research Authority (HRA) supports the use of model agreements. The latest models can be used throughout the UK and have been updated to reflect current practice and regulation. The tripartite agreement is intended to be used when the management of a commercial clinical trial is outsourced by the sponsor to a contract research organisation. Das CRO mCIA wird von den britischen Gesundheitsabteilungen, dem National Institute for Health Research, der Association of British Healthcare Industries, der NHS Confederation, dem Medical Schools Council, der UK Clinical Research Collaboration, dem NHS R & D Forum und dem Institute for Clinical Research empfohlen. Die Association of the British Pharmaceutical Industry (ABPI), Health and Care Research Wales (HCRW), Health and Social Care Northern Ireland (HSC NI), die Health Research Authority (HRA, England) und NHS Research Scotland (NRS) haben die Versionen vom März 2020 des commercial model Clinical Trial Agreement (mCTA) und des Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) verabschiedet. die erstmals 2003 bzw. 2007 veröffentlicht wurden. These model agreements have been designed to streamline the process of authorising commercial studies and should therefore be used without modification by sponsors who conduct clinical trials on NHS/HSC patients in hospitals across the UK healthcare system. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support clinical research cooperation involving the pharmaceutical and biotechnology industry, universities and NHS organisations across Britain.
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