This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will help in-house counsel, data protection officers and other clinical trial stakeholders to address inconsistencies across Europe and other regions in the application of data privacy laws to clinical trials. In so doing, it responds to common challenges faced by our clients.
Clinical trials involve the processing of personal information relating to study participants and other individuals, triggering the applicability of data privacy laws. That processing is typically undertaken by a complex network of related parties – from the sponsor to the trial site to a CRO. How data privacy laws apply in this context can affect the development of a clinical trial and the use of its results.
It is also often the case that clinical trials take place across borders, involving sites in several jurisdictions. This adds further complexity, as it is well-recognized that data privacy requirements are not aligned in all jurisdictions and the interplay between data privacy laws and clinical trials may create significant challenges and the need to adapt processes and policies for each country.
The Guide covers 25 jurisdictions and offers an overview of the main privacy-related issues arising within clinical trials. The Guide helps identify possible opportunities, challenges, and risks in each jurisdiction. It’s an easy-to-use interactive tool that simplifies cross-jurisdictional comparison. You can also download a PDF version of the information required.
To access Cross-border Guide to Clinical Trials and Privacy Matters, click here.