Glossary:TAG-00253-Rep-att

Glossary > Reporting timeline

Reporting timeline
Tag-ID	TAG-00253-Rep-att
English	Reporting timeline / Reporting deadline / Reporting timeframe
French	Délai de déclaration / Délai de notification / Délai de rapport
German	Meldefrist / Berichterstattungsfrist / Meldefristen

References

	Scope	Document part	Language	Document
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4)	NIS	§ 63f (4)	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NIS	NIS	§ 67 (6) - NIS	DE	DEU AMG - Arzneimittelgesetz 19-Jul-2023
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001	MD	8	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002	MD	8	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001	MD	8.2	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002	MD	8.2	EN	EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2	G	3.2	EN	EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4	G	4	EN	EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5	MD	Article 87 Paragraph 3 – 5	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c)	HM	Article 10 (c)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made	HM	D When should the notification be made	EN	GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
GBR MEDDEV 2.7/3 revision 3 May-2015 7.1	MD	7.1	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
GBR MEDDEV 2.7/3 revision 3 May-2015 7.2	MD	7.2	EN	GBR MEDDEV 2.7/3 revision 3 May-2015
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6)	HM	Article 15 (1) - (6)	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 27	HM	Article 27	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E2A Guideline 1994 III B. - III C.	G	III B. - III C.	EN	ICH ICH E2A Guideline 1994
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-001	MD	§ 812.150 (b) (7)	EN	USA 21 CFR Part 812 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.24	G	§ 11.24	EN	USA 42 CFR Part 11 09-Apr-2025
USA 42 CFR Part 11 09-Apr-2025 § 11.44	G	§ 11.44	EN	USA 42 CFR Part 11 09-Apr-2025
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 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