Optional information:

• Guidance for the conduct of good clinical practice inspections (August 2017)
• Annex I – to guidance for the conduct of good clinical practice
• inspections – investigator site (September 2017)
• Annex II – to guidance for the conduct of good clinical practice
• inspections – clinical laboratories (August 2017)
• Annex III – to guidance for the conduct of good clinical practice
• inspections – computer systems (September 2023)
• Annex IV – to guidance for the conduct of good clinical practice
• inspections – sponsor and CRO (August 2017)
• Annex VI – to guidance for the conduct of good clinical practice inspections – record
• keeping and archiving of documents (June 2017)
• Annex VII – to guidance for the conduct of good clinical practice inspections – bioanalytical part,
• pharmacokinetic and statistical analyses of bioequivalence trials (June 2017)
• Guidance for the preparation of good clinical practice inspections (August 2017)
• Guidance for the preparation of GCP inspection reports and communication of
• inspection findings (February 2022)
• Guidance for coordination of GCP inspections requested in the context of marketing authorisation
• applications for mutual recognition and decentralised procedures and cooperation between Member States (March 2018)
• Annex V – to guidance for the conduct of good clinical practice inspections – Phase I unit (November 2022)