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GUIDELINE Step 4

E3 Structure and Content of Clinical Study Reports

E3 International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

Required structure for clinical study reports submitted in support of a marketing authorisation.

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METADATA
TypeGUIDELINE
Year1995
VersionStep 4
StatusCurrent
FormatPDF
Pages48
Size1.0 MB
Last reviewedNOV 1995
SOURCE
PDF · CANONICAL LINK https://database.ich.org/sites/default/files/E3_Guideline.pdf ↗
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