The current regulatory landscape requires public disclosure of clinical trial (CT) data and documents.
The EU General Data Protection Regulations (GDPR) requires that personal data in these documents be protected. Though divergent at first glance, these new requirements actually are aligned to benefit patients. As clinical researchers, we need to find the right balance between disclosure and data protection while maintaining the scientific utility of the documents we write.
The objective of this workshop is to help clinical researchers deal with increased requirements (with focus in the EU) in data transparency and public disclosure in both pharma and medical devices.
In particular, the requirements under the EU Clinical Trials Regulation, the EU Medical Device Regulation and the EMA Policy 0070 will be discussed.
An introduction to the different public disclosure platforms, ie, EMA clinical data website, EU Clinical Trial Information System (CTIS), and the European Database for Medical Devices (EUDAMED) will be made.