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What is the current reference document for ethics in paediatric clinical trials?

April 26, 2017clinical trials DOCUMENT Ethics paediatric Reference

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What is the current reference document for ethics in paediatric clinical trials?

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The reference document is ETHICAL CONSIDERATIONS FOR CLINICAL TRIALS ON MEDICINAL PRODUCTS WITH THE PAEDIATRIC POPULATION, released by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC1 relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood.