Unblinding – Let Me Count the Ways… (8of11) GCP Data Integrity

Jean Mulinde from CDER’s Office of Scientific Investigations and Gail Francis from MHRA helps participants understand 1) the basics of how data flows through various systems as it is collected, integrated, transformed, analyzed and reported for clinical trials, 2) how there are many ways in which clinical trial data may be unintentionally unblinded, and 3) premature unblinding of data that permits identification of subjects’ treatment allocation may raise significant concerns related to the adequacy of data integrity and data quality for a clinical trial.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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