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GUIDANCE Final

Electronic Source Data in Clinical Investigations

FDA · 2013 U.S. Food & Drug Administration
ABSTRACT — EDITORS' SUMMARY

Identification, capture, and review of electronic source data. ALCOA-aligned expectations for sponsor and investigator handling of eSource.

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METADATA
TypeGUIDANCE
Year2013
VersionFinal
StatusCurrent
FormatPDF
Pages14
Size380 KB
Last reviewedSEP 2013
SOURCE
PDF · CANONICAL LINK https://www.fda.gov/media/85183/download ↗
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