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Document:ICH ICH E11 Guideline R1 (2017): Difference between revisions

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Revision as of 12:54, 16 July 2026


Document information
Reference ICH ICH E11 Guideline R1 (2017)
Validity area ICH
Scope(s) G
Document name ICH E11 Guideline
Version / Revision R1 (2017)
Status Current
Document type International guideline
Language(s) EN
Description CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

References

 ScopeDocument partLanguagePreview
ICH ICH E11 Guideline R1 (2017) -G-ENCLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION…
ICH ICH E11 Guideline R1 (2017) 8G8EN8. GLOSSARY

Parental (legal guardian) consent/permission:

Expression of understanding and agreement by fully informed parent(s) or legal guardian to …


References

Reference Scope Document part Language Preview
Reference:ICH ICH E11 Guideline R1 (2017) - G - EN CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
Reference:ICH ICH E11 Guideline R1 (2017) 8 G 8 EN 8. GLOSSARY Parental (legal guardian) consent/permission: Expression of understanding and agreement by fully informed parent(s) or legal guardian to permit the investigator/sponsor of a clinical ...