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Data Integrity in Clinical Trials July 3, 2020

Posted by Michael Hamrell in Uncategorized.
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In October 2018, the MHRA and FDA held a 2-day event in Washington, where MHRA  and US FDA GCP Inspectors joined forces to discuss data integrity.  As an outcome from that meeting, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.

https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.1794

If you are having trouble obtaining a copy of the article, contact the Corresponding Author at FDA and request one.