Talk Quality & Monitoring track
The Many Faces of Clinical Data Integrity
Thu, Feb 6, 2025 · 10:10–10:40 AM EST Rosen Shingle Creek
About this session
The ICH E6 (R3) draft requires data monitoring to extend across multiple data integrity aspects which span from patient eligibility to unexpected lack of variability and potential data manipulations. From a centralized monitoring perspective, such a broad scope requires not only a variety of data analysis techniques, but also different approaches to handling insights generated from the data. In this session, I am going to discuss how a “one size does not fit all” principle applies to signal detection methods and findings management.
