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Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017: Difference between revisions

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Revision as of 12:54, 16 July 2026


Document information
Reference EU EMA/431265/2016

Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017

Validity area EU
Scope(s) G
Document name EMA/431265/2016

Annex I – to guidance for the conduct of good clinical practice inspections – investigator site

Version / Revision 06-Sep-2017
Status Current
Document type Official guideline
Language(s) EN
Description EMA/431265/2016

Annex I – to guidance for the conduct of good clinical practice inspections – investigator site

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

References

 ScopeDocument partLanguagePreview
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.G4.EN4. Informed consent of trial subjects

[…]

Documentation in the source data of the process of obtaining the initial informed consent and subsequent con…


References

Reference Scope Document part Language Preview
Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. G 4. EN 4. Informed consent of trial subjects […] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric assent and ...
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