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Of Course My Data Has Integrity … And I Can Prove It
Session Chair(s)
David Fryrear, MS
Executive Vice President and Head of Quality Assurance
Astellas, United States
Presenters will share 1) an overview of the data integrity expectations for good clinical practice (GCP) (using MHRA draft guidance as foundation); 2) case studies (with different data sources and media) of how the described expectations have been executed in the GCP environment; and 3) differences between data quality and data integrity.
Learning Objective : Distinguish between data quality and data integrity; Describe attributes and application of data integrity expectations in the GCP environment.
Speaker(s)
Applying Data Integrity to Clinical Trials and Regulator Expectations: Comparing Standards from the FDA, EMA, and MHRA
Sherri Ann Hubby
Myovant Sciences , United States
Senior Director, GCP Quality Assurance
Data Integrity in FDA-Regulated Clinical Trials
Adam C. Donat, MS
FDA, United States
Deputy Division Director, Clinical Science and Quality, OPEQ, CDRH
Data Integrity: Not an Act But a Habit
Cinzia Piccini
Eli Lilly and Company, Italy
Medical Quality Organization, Biometrcis Consultant
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