{"id":72908,"date":"2016-08-01T15:25:02","date_gmt":"2016-08-01T15:25:02","guid":{"rendered":"http:\/\/mostafa.openonline.co.uk\/?guid=ee414b13b6e845883b612ba92e33701b"},"modified":"2016-08-01T15:25:02","modified_gmt":"2016-08-01T15:25:02","slug":"news-story-clinical-trials-regulations-have-your-say","status":"publish","type":"post","link":"https:\/\/mostafa.openonline.co.uk\/?p=72908","title":{"rendered":"News story: Clinical Trials Regulations \u2013 have your say"},"content":{"rendered":"
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Following the EU referendum, MHRA continues to play a full, active role in European regulatory procedures. The UK is assessing the potential impact on our regulatory framework of the decision to leave the EU. At present, we continue with our programme for implementing the Clinical Trials Regulations and we remain an EU Member State with the rights and responsibilities this entails.<\/p>\n

This consultation seeks the views of stakeholders \u2013 and other interested parties \u2013 on the document regarding \u201cRisk proportionate approaches in clinical trials\u201d. The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.<\/p>\n

There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536\/2014:<\/p>\n