Clinical Trial Agreement Template Gdpr

Despite their intention, requests to amend MCTAs had increased significantly in recent years, mainly due to the obsolescence of the data protection rules contained in the proposals that did not fully take into account the application of the General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018 (DPA). While the above-mentioned amendments offer a pleasant level of protection to contracting parties, the updated templates have not comprehensively addressed some of the problems faced by the business community with the 2018 versions of the MCTAs. Overall, parties that have received the updated MCTAs and CRO-MCTAs may feel safe and protected by the new models that significantly improve the limited protection of previous documentation. In addition, and in view of the withdrawal of the United Kingdom from the European Union, it would have been desirable for the revised proposals to contain explicit language relating to the law of the United Kingdom and the United Kingdom, thus providing adequate protection after Brexit. The adoption of this more robust documentation is particularly welcome in the current climate and is an important step forward in addressing the need to streamline COVID-19 clinical trials. These needs are also reflected in the accelerated authorization procedure for COVID 19 studies, which has gone from about 80 days to just 24-72 hours. As with the models for 2018, the HRA expects the new mCTA and CRO-mCTA to be used without modification. Updated versions of the UK Clinical Trial Agreement (mCTA) model and the Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTA) have been published. Given the growing importance of safe but rapid clinical trials in times of coronavirus, this article describes the main changes from a data protection perspective and what they mean for Contracting Parties. 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.

MCTAs were developed by the UK government in collaboration with the Association of the British Pharmaceutical Industry (ABPI), including by interest groups such as the Health Research Authority and the Medical Research Council. There are also separate standard agreements for non-commercial research/studies initiated by controlling physicians, collaborative research, and studies in the field of primary care. The MCTA is a standard contract that must be used without modification by sponsors of clinical trials and NHS/HSC organisations….

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