This interactive training will provide essential insights to the key requirements for Data Integrity and Data Protection.
The key principles of EU General Data Protection Regulation (GDPR) dedicated to the data privacy project team: it is the first step in the compliance journey to ensuring GDPR. The regulation, the definition of personal data, sensitive data, a vulnerable person, and of critical processes per GDPR. Discover what pseudonymised personal data is and when personal data can be considered fully anonymised. Learn the countries and people impacted by GDPR, the new deadlines, penalties, and a simple implementation approach. Understand the interplay of GDPR with existing regulations and guidelines from the life sciences sector (GxPs).
The key principles of Data Integrity: organisations taking responsibility for the systems they use and the data they generate; paper or electronic. That organisations understand the criticality of their data and any inherent risk to integrity. Key goal is that organisations can stand over the integrity of their Clinical Trial data and thus any decisions they make based on these data.
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Phetairos is an associate community of world-class biopharmaceutical consultants and subject matter experts. We help our clients by using our combined experience and industry best practice to design and deliver innovative solutions across the entire biopharmaceutical value chain. Our independent “hands-on” approach helps our clients to release the full potential of their products, organisations & people. We are dedicated to consistent delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment, transparency and knowledge sharing. www.phetairos.com .
Requirements to meet data integrity in Clinical Trials
Definition of ‘raw data’
Data Protection Officer
Protocol deviations and data breach
Understand data governance measures
Commonalities and differences between GxP and GDPR