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EMA Advises Study Sponsors To Amend Informed Consent Forms | Allen & Overy LLP

To embed, copy and paste the code into your website or blog: Consent Forms (ICF) to include an explicit reference as to the possibility that EU inspectors would have access to medical records and personal data of clinical trial participants. In February 2021, the European Medicines Agency updated its guidance in the form of questions and answers (Q&As) on Good Clinical Practice (GCP). GCP is a code of international standards concerning several aspects of clinical trials. In particular, it aims to assure that a study’s results are credible and accurate and that the rights and confidentiality of the study subjects are protected.

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