GDPR IN A GLOBAL PERSPECTIVE On 25th May 2018 the General Data Protection Regulation (GDPR) came into effect within the EU. These requirements affect all companies within the EU, including those performing clinical research. Many of the responsibilities and obligations defined by GDPR are not new for companies in the clinical research sector, as similar requirements already exist in the regulations governing clinical research, such as ICH GCP E6 â€˜Good Clinical Practiceâ€™. Many requirements are also similar to requirements to be found in local data privacy regulations in other parts of the world. GDPR applies to companies and data subjects in the EU, but clinical research has become increasingly global in its scope. This article describes how different types of global clinical research projects are affected by GDPR.
30 | QUASAR | JANUARY JANUARY2019 2019
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