< Back

Personal Data Protection in the Clinical Trial Disclosure Era: Compliance with EMA Policy 0070 and the GDPR

Drug Development
Workshop profile:
This workshop is for medical writers at different stages of their career. There is no prerequisite in order to participate but a basic knowledge of clinical trial documents is expected.
The EMA Policy 0070 requires public disclosure of clinical trial (CT) 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 medical writers, 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 medical writers deal with different CT documents impacted by the EMA Policy 0070 and the GDPR. The participant will gain knowledge in identifying critical patient data and the “risk areas” of a CT document or project, and in mitigating risks to confidentiality and of non-compliance.
The workshop will cover: · a short introduction to CT transparency and disclosure, the key regulations (i.e., EMA Policy 0070, GDPR), and definitions of key terms · benefits, challenges, and risks of disclosure · CT documents impacted, with focus on the study protocol and the clinical study report · personal data pseudonymisation (“redaction-friendly”) techniques at the document level · working with other functional groups to ensure patient data protection in CT documents Hands-on exercises will be provided on · identifying data protection risks · pseudonymisation strategies to mitigate risks to patient confidentiality.