The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology
New requirements must be put in place to ensure data quality and integrity.
When Should the Audit Trail Begin?
A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
How Does GDPR Affect Clinical Trials?
The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.