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Glossary:TAG-00034-Inv-Bro

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Glossary > Investigator's brochure

Investigator's brochure
Tag-ID TAG-00034-Inv-Bro
English Investigator's brochure / IB
French Brochure pour l'investigateur / Brochure investigateur
FR Abbr. BI
German Prüferinformation / Investigator's Brochure / Prüferinformationsbroschüre
DE Abbr. PI

References

 ScopeDocument partLanguageDocument
ICH ICH E6 Guideline R3 (2025) Appendix AGAppendix AENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) Appendix A 3.4GAppendix A 3.4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB)GGLOSSARY - Investigator’s Brochure (IB)ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1MD7.5.1ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex BMDAnnex BENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5)HM§ 312.23 (a) ; (5)ENUSA 21 CFR Part 312 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6HM4.6ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochureHMGlossary - investigator’s brochureENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995