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GUIDELINE Step 4

E2A Clinical Safety Data Management — Definitions and Standards for Expedited Reporting

E2A International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

The ICH foundation for expedited safety reporting. Defines unexpectedness, seriousness, and reporting timelines.

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METADATA
TypeGUIDELINE
Year1994
VersionStep 4
StatusCurrent
FormatPDF
Pages22
Size480 KB
Last reviewedOCT 1994
SOURCE
PDF · CANONICAL LINK https://database.ich.org/sites/default/files/E2A_Guideline.pdf ↗
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