View source for Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -

{{ReferenceData
|has_document=Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
|module=2
|unit=2.1.3
|scope=NIS
|doc_part=-
|language=EN
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00285-Pha-enk ++ TAG-00033-Pro-oto ++ TAG-00340-Req-nfo
|tags_display=[[Glossary:TAG-00285-Pha-enk|Post-authorisation safety study]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
|comment=Format and content of PASS study protocol (GVP Module VIII)
|content=[...]
VIII.B.3. Study protocol
[...]
VIII.B.3.1. Format and content of the study protocol
[...]
}}