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Of Course My Data Has Integrity … And I Can Prove It
Session Chair(s)
David Fryrear, MS
Chief Quality Officer, 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Presenters will share 1) an overview of the data integrity expectations for good clinical practice (GCP) (using MHRA draft guidance as foundation); 2) case studies (with different data sources and media) of how the described expectations have been executed in the GCP environment; and 3)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
Director, Clinical Quality Assurance, Vera Therapeutics, United States
Data Integrity in FDA-Regulated Clinical Trials
Deputy Division Director, Clinical Science and Quality, OPEQ, CDRH, FDA, United States
Data Integrity: Not an Act But a Habit
Medical Quality Organization, Biometrcis Consultant, Eli Lilly and Company, Italy
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