Zosa MD, 6/09

Zosa MD, 6/09

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Warning Letter noting failure to generate or retain documentation to corroborate data in the electronic system.

Description

Zosa MD, 6/09

This Warning Letter includes observations regarding (1) lack of source documentation at the site to corroborate data entered into the electronic Case Report Forms (eCRF) for enrolled subjects.

pa document category Warning Letter
Regulation Category Drugs – Clinical Trials
FDA Office CDRH
System Category Clinical Trial
Citation Category Data Integrity

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