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Glossary:TAG-00017-Spo-die

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Glossary > Sponsor

Sponsor
Tag-ID TAG-00017-Spo-die
English Sponsor / Trial sponsor
French Promoteur / Promotrice / Promoteur de l'essai
German Sponsor / Sponsorin / Studienverantwortlicher / Studienverantwortliche / Auftraggeber / Auftraggeberin

References

 ScopeDocument partLanguageDocument
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24HM§ 4 Absatz 24DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9NISLeitlinie 9DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7G§ 7DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8G§ 8DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48MD§ 48DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 53MD§ 53DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001MD8.2ENEU ; 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 8.2-002MD8.2ENEU ; 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 3.2G3.2ENEU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002G2.5ENEU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3G3ENEU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7MDArticle 70 Paragraph 6 – 7ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 – 7IVDArticle 66 Paragraph 6 – 7ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 11GArticle 11ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12GArticle 12ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 13GArticle 13ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 14GArticle 14ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21HMArticle 21ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22HMArticle 22ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 5GArticle 5ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52HMArticle 52ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54HMArticle 54ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 8GArticle 8ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 9GArticle 9ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notifyHMD Who should notifyENGBR 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 5 - 6MD5 - 6ENGBR MEDDEV 2.7/3 revision 3 May-2015
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 17HMArticle 17ENGBR 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 22-23HMArticle 22-23ENGBR 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 29AHMArticle 29AENGBR 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 3 (1) - (5)HMArticle 3 (1) - (5)ENGBR 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 3 (6) - (11)HMArticle 3 (6) - (11)ENGBR 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 30-001HMArticle 30ENGBR 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 30-002HMArticle 30ENGBR 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 34HMArticle 34ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3HMAnnex 2 3ENICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) GLOSSARY - SponsorGGLOSSARY - SponsorENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-InvestigatorGGLOSSARY - Sponsor-InvestigatorENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3GIII. Annex 1 3ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.1.4GIII. Annex 1 3.1.4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1GIII. Annex 1 3.13.1ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5GIII. Annex 1 3.5ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6GIII. Annex 1 3.6ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8GIII. Annex 1 3.8ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3GIII. Annex 1 3.9.3ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 4GIII. Annex 1 4ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2MD9.2.2ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - SponsorHM§ 312.3 (b) - SponsorENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-InvestigatorHM§ 312.3 (b) - Sponsor-InvestigatorENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.31HM§ 312.31ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.33HM§ 312.33ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3)HM§ 312.33 (a) (3)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.38HM§ 312.38ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d)HM§ 312.40 (c) (d)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.50HM§ 312.50ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c)HM§ 312.53 (c)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d)HM§ 312.64 (c) - (d)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e)G§ 50.3 (e)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (f)G§ 50.3 (f)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.105G§ 56.105ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n)MD§ 812.3 (n)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (o)MD§ 812.3 (o)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.40MD§ 812.40ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.45MD§ 812.45ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c)MD§ 812.7 (c)ENUSA 21 CFR Part 812 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11HM4.11ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17HM4.17ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - AmendmentHM4.4 - AmendmentENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazardHM4.4 - immediate hazardENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5HM5ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6HM5.6ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsorHMGlossary - sponsorENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WMA Declaration of Helsinki 2024 34G34ENWMA Declaration of Helsinki 2024
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