Quality and Control of Clinical Trial Data (6of11) GCP Data Integrity Workshop

MHRA’s Lead Senior GCP Inspector Andy Fisher discusses data integrity and data life cycle in data management to include:

• Data Capture (CRFs and Electronic Data Transfer)
• Investigator control of the data
• Management of investigator source and transcribed data including eSource
• worksheets & health records
• Validation of eSystems (e.g. eCRF)
• Management of data changes
• Prevention of unauthorised changes/deletion (database lock)
• Assessment of impact of non-compliance on data quality/reliability
• Traceability of data during analysis
• Data retention

For more data integrity case studies, visit https://www.fda.gov/drugs/cder-small-...

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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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