Data Integrity and Data Protection in Clinical Trials

Data integrity remains a hot topic in all regulatory environments and is equally important in non-regulatory systems such as academia and early phase development.  Personal data protection remains critical to the success of our industry. The GDPR is now one year old and our industry is beginning to find its way.

•In this course we look at what data integrity means in different contexts, where the potential risks and pitfalls are and how we can minimise these. 

•We will also look at quality culture and what we can do to minimise risks in areas that we can’t SOP such as behaviour indicators which may indicate risks for misconduct.

•Understanding of the principles and definitions used in the GDPR and discuss the ways in which clinical trials may achieve compliance with both the Clinical Trials legislation and the GDPR.

•Changes and adaptations required particularly related to contracts, consent and data transfers, and understand how to identify a data breach and what to do about it