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Document information
Reference EU EMA Guidelines -
Validity area EU
Scope(s) HM
Document name EMA Guidelines
Version / Revision -
Status N.A.
Document type Corpus of texts
Language(s) EN
Description European Medicines Agency (EMA)

Examples:

- EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials

- EMA/INS/GCP/126568/2023 – Annual Report of the Good Clinical Practice [GCP) Inspectors' Working Group [IWG) 2022

- EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation [EU) No 536/2014 or the clinical trial protocol

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors