GDPR – what happens with clinical research when Britain leaves the union?

On 25th May 2018 the General Data Protection Regulation (GDPR) came into effect within the EU – and soon Great Britain is leaving the union with what could be a “hard Brexit”. 

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 ‘Good Clinical Practice’. 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 and now a major clinical research member country is leaving the union. This article by Viedoc’s Quality Manager Alan Yeomans describes how different types of global clinical research projects are affected by GDPR and gives a detailed view of how GDPR applies to the jurisdiction of data subjects, sponsors and vendors.

Read the full article here.