The Spanish Data Protection Authority published, on last February, the “Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance” (CoC). The CoC regulates how data protection rules impact the development of clinical trials and compliance with pharmacovigilance obligations.
Regarding clinical trials, the CoC establishes protocols which facilitate the application of the General Data Protection Regulation (GDPR) and provides certainty on how its provisions apply to this particular context, while for pharmacovigilance, the CoC distinguishes between the processing of directly identifiable and coded personal data, establishes uniform pharmacovigilance protocols, analyses different data communications, and assesses different reporting procedures.
While applicable at the national level, the CoC could become a benchmark at the European level as it is the first code in this field to be approved in Europe.
You can find more information here.
