Eudralex Volume 10 Guideline for good clinical practice - ICH E6(R2)- EMA/CHMP/ICH/135/1995
Titel:
Eudralex Volume 10 Guideline for good clinical practice - ICH E6(R2)- EMA/CHMP/ICH/135/1995
Kurztitel:
ICH E6
Internet:
Herkunft/Verlag:
ICH/EMA
Dokumentenart:
Guideline
Inhalt:
The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.