View source for Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.

{{ReferenceData
|has_document=Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017
|module=3
|unit=3.1.1
|scope=G
|doc_part=4.
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte
|tags_display=[[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00112-Ass-nve|Assent]], [[Glossary:TAG-00029-Inf-rte|Informed consent]]
|comment=Need of documentation of the Informed Consent Process in Source records
|content=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 emergency consent, if applicable.
}}