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Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022: Difference between revisions

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Revision as of 12:54, 16 July 2026


Document information
Reference EU EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022

Validity area EU
Scope(s) G
Document name EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE

Version / Revision 2022
Status Current
Document type Official guideline
Language(s) EN
Description EMA/INS/GCP/143492/2022

Good Clinical Practice Inspectors Working Group (GCP IWG)

ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE

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

References

 ScopeDocument partLanguagePreview
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6GPage 6EN[…] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric …


References

Reference Scope Document part Language Preview
Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 G Page 6 EN […] 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. […]
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