Glossary:TAG-00252-Exp-hle

Glossary > Expedited reporting

Expedited reporting
Tag-ID	TAG-00252-Exp-hle
English	Expedited reporting / Expedited safety reporting
EN Abbr.	ER
French	Déclaration accélérée / Déclaration de sécurité accélérée
FR Abbr.	DA
German	Beschleunigte Meldung / Beschleunigte Sicherheitsmeldung

References

	Scope	Document part	Language	Document
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1	G	Section 7 7.3.1	EN	EU 2011/C 172/01 - CT-3 11-Jun-2011
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3	G	Section 7 7.3.3	EN	EU 2011/C 172/01 - CT-3 11-Jun-2011
ICH ICH E2A Guideline 1994 III B. - III C.	G	III B. - III C.	EN	ICH ICH E2A Guideline 1994
USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c)	HM	§ 312.32 (c)	EN	USA 21 CFR Part 312 09-Apr-2025
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.	G	Introduction ; III. B. ; IV.	EN	USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3	G	4.3	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2	G	5.3.2	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1	G	Appendix 1	EN	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024