| | Scope | Document part | Language | Document |
|---|
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2 | HM | § 2
Absatz 1 – 2 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23 | HM | § 4
Absatz 23 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24 | HM | § 4
Absatz 24 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25 | HM | § 4
Absatz 25 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34 | HM | § 4
Absatz 34 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001 | NIS | 1.1 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 | NIS | 1.1 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1 | NIS | 2.1 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1 | NIS | 3.1 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2 | MD | § 2 | DE | DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 | MD | § 3 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4 | MD | § 3
Absatz 4 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6 | MD | § 3
Absatz 5 – 6 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2 | G | Article 2 | EN | EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 |
| EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2 | G | Article 2 | EN | EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 |
| EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 | G | 5.1 | 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/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4 | G | 4.4 | EN | EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 |
| 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 5.1 - 5.2-001 | G | 5.1 - 5.2 | EN | 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 |
| 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 5.1 - 5.2-002 | G | 5.1 - 5.2 | EN | 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 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 | MD | Article 2
Paragraph 1 - 3 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14 | MD | Article 2
Paragraph 14 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8 | MD | Article 2
Paragraph 4 – 8 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45 | MD | Article 2
Paragraph 45 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46 | MD | Article 2
Paragraph 46 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 57 – 59 | MD | Article 2
Paragraph 57 – 59 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62 | MD | Article 2
Paragraph 62 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 | MD | Article 2
Paragraph 64 – 66 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 | IVD | Article 2
Paragraph 11 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 | IVD | Article 2
Paragraph 14 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 | IVD | Article 2
Paragraph 2 – 3 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 | IVD | Article 2
Paragraph 42 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 | IVD | Article 2
Paragraph 45 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 | IVD | Article 2
Paragraph 58 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 60 – 62 | IVD | Article 2
Paragraph 60 – 62 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 67–69 | IVD | Article 2
Paragraph 67–69 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 | HM | Article 2 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 13 | HM | Article 2
Paragraph 13 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1 | HM | Article 2
Paragraph 2
No. 1 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2 | HM | Article 2
Paragraph 2
No. 2 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3 | HM | Article 2
Paragraph 2
No. 3 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4 | HM | Article 2
Paragraph 2
No. 4 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 | G | Article 3
Paragraph 10 | EN | EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 |
| FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 | G | R1123-46 | FR | FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) | HM | Article 2 (a) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) | HM | Article 2 (c) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) | HM | Article 2
(l) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) | HM | Article 2
(m) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n) | HM | Article 2
(n) | 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 What needs to be reported | HM | D
What needs to be reported | 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 4 | MD | 4 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device | MD | Article 2
in vitro diagnostic medical device | EN | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device | MD | Article 2
medical device | EN | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 | HM | Article 11 | 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 2 (1) | HM | Article 2 (1) | 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 2 clinical trial | HM | Article 2
clinical trial | 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 2 investigational medicinal product | HM | Article 2
investigational medicinal product | 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 2 investigator | HM | Article 2
investigator | 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 2 non-interventional trial | HM | Article 2
non-interventional trial | 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 2 relevant ethics committee | HM | Article 2
relevant ethics committee | 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 3 (1) - (5) | HM | Article 3
(1) - (5) | 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 Part 1 Article 2 | HM | Part 1
Article 2 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR) | G | GLOSSARY - Adverse Drug Reaction (ADR) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE) | G | GLOSSARY - Adverse Event (AE) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement | G | GLOSSARY - Agreement | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit | G | GLOSSARY - Audit | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking | G | GLOSSARY - Blinding/Masking | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Case Report Form (CRF) | G | GLOSSARY - Case Report Form (CRF) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Certified Copy | G | GLOSSARY - Certified Copy | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial | G | GLOSSARY - Clinical Trial | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial/Study Report (CSR) | G | GLOSSARY - Clinical Trial/Study Report (CSR) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Comparator | G | GLOSSARY - Comparator | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) | G | GLOSSARY - Compliance (in relation to trials) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation | G | GLOSSARY - Computerised Systems Validation | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Contract Research Organisation (CRO) | G | GLOSSARY - Contract Research Organisation (CRO) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Data Acquisition Tool (DAT) | G | GLOSSARY - Data Acquisition Tool (DAT) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC) | G | GLOSSARY - Independent Data Monitoring Committee (IDMC) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection | G | GLOSSARY - Inspection | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | G | GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Interim Clinical Trial/Study Report | G | GLOSSARY - Interim Clinical Trial/Study Report | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product | G | GLOSSARY - Investigational Product | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator | G | GLOSSARY - Investigator | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigator’s Brochure (IB) | G | GLOSSARY - Investigator’s Brochure (IB) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Metadata | G | GLOSSARY - Metadata | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Protocol Amendment | G | GLOSSARY - Protocol Amendment | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation | G | GLOSSARY - Randomisation | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities | G | GLOSSARY - Regulatory Authorities | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) | G | GLOSSARY - Serious Adverse Event (SAE) | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Service Provider | G | GLOSSARY - Service Provider | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Signature | G | GLOSSARY - Signature | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Source Records | G | GLOSSARY - Source Records | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor | G | GLOSSARY - Sponsor | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sponsor-Investigator | G | GLOSSARY - Sponsor-Investigator | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Sub-Investigator | G | GLOSSARY - Sub-Investigator | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Vulnerable Participants | G | GLOSSARY - Vulnerable Participants | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E9 Guideline 1998 Glossary - Dropout | HM | Glossary - Dropout | EN | ICH ICH E9 Guideline 1998 |
| ICH ICH E9 Guideline 1998 Glossary - IDMC | HM | Glossary - IDMC | EN | ICH ICH E9 Guideline 1998 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12 | MD | 3.12 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19 | MD | 3.19 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2 | MD | 3.2 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24 | MD | 3.24 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26 | MD | 3.26 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29 | MD | 3.29 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33 | MD | 3.33 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization | MD | 3.42 - randomization | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment | MD | 3.42 - recruitment | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45 | MD | 3.45 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46 | MD | 3.46 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47 | MD | 3.47 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48 | MD | 3.48 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5 | MD | 3.5 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52 | MD | 3.52 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55 | MD | 3.55 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8 | MD | 3.8 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 | MD | Annex A - medical device | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 | MD | Annex A - medical device | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO | HM | § 312.3
(b) - CRO | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor | HM | § 312.3
(b) - Sponsor | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation | HM | § 312.3 - Clinical investigation | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC | HM | § 312.3 - IEC | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event | HM | § 312.32 - Adverse event | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction | HM | § 312.32 - Suspected adverse reaction | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 | G | § 50.3 | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c) | G | § 50.3
(c) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d) | G | § 50.3
(d) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (e) | G | § 50.3
(e) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g) | G | § 50.3
(g) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (h) | G | § 50.3
(h) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i) | G | § 50.3
(i) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) | G | § 50.3
(j) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001 | G | § 50.3
(k) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002 | G | § 50.3
(k) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (l) | G | § 50.3
(l) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (m) | G | § 50.3
(m) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n) | G | § 50.3
(n) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o) | G | § 50.3
(o) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p) | G | § 50.3
(p) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q) | G | § 50.3
(q) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r) | G | § 50.3
(r) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (s) | G | § 50.3
(s) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m) | G | § 56.102
(m) | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 809 06-May-2024 § 809.3 (a) | G | § 809.3
(a) | EN | USA 21 CFR Part 809 06-May-2024 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e) | MD | § 812.3
(e) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) | MD | § 812.3
(f) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) | MD | § 812.3
(g) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (i) | MD | § 812.3
(i) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (j) | MD | § 812.3
(j) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) | MD | § 812.3
(m) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (n) | MD | § 812.3
(n) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (p) | MD | § 812.3
(p) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (q) | MD | § 812.3
(q) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) | MD | § 812.3
(r) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (s) | MD | § 812.3
(s) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t) | MD | § 812.3
(t) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5) | G | § 11.10
(b) (5) | EN | USA 42 CFR Part 11 09-Apr-2025 |
| USA 45 CFR Part 160 09-Apr-2025 - | G | - | EN | USA 45 CFR Part 160 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 Subpart C | G | Subpart C | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b) | G | § 46.102
(b) | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (e) (1) | G | § 46.102
(e) (1) | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.102 (m) | G | § 46.102
(m) | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) | G | Sec 737 (8) | EN | USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 |
| USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS | G | GLOSSARY OF TERMS | EN | USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. | G | 2.1.1. | 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 2.1.14. | G | 2.1.14. | 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 2.1.2 | G | 2.1.2 | 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 2.1.21. | G | 2.1.21. | 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 2.1.28 | G | 2.1.28 | 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 2.1.32 - 2.1.34 | G | 2.1.32 -
2.1.34 | 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 5.3.1 | G | 5.3.1 | 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 NIH - Glossary 27-May-2025 Observational study | G | Observational study | EN | USA NIH - Glossary 27-May-2025 |
| USA U.S. Code Title 21 30-Sep-2023 § 321 (f) | G | § 321 (f) | EN | USA U.S. Code Title 21 30-Sep-2023 |
| USA U.S. Code Title 21 30-Sep-2023 § 321 (h) | G | § 321 (h) | EN | USA U.S. Code Title 21 30-Sep-2023 |
| USA U.S. Code Title 21 30-Sep-2023 § 321 (i) | G | § 321 (i) | EN | USA U.S. Code Title 21 30-Sep-2023 |
| WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS | G | 1.1 - NIS | EN | WHO WHO - Guidance for best practices for clinical trials 2024 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP) | HM | Glossary - Good Clinical Practice (GCP) | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event | HM | Glossary - adverse event | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction | HM | Glossary - adverse reaction | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial | HM | Glossary - audit of a trial | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF) | HM | Glossary - case -report form (CRF) | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial | HM | Glossary - clinical trial | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product | HM | Glossary - comparator product | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract | HM | Glossary - contract | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO) | HM | Glossary - contract research organization (CRO) | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment | HM | Glossary - escape treatment | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee | HM | Glossary - ethics committee | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report | HM | Glossary - final report | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent | HM | Glossary - informed consent | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection | HM | Glossary - inspection | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product) | HM | Glossary - investigational product (synonym: study product) | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator | HM | Glossary - investigator | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure | HM | Glossary - investigator’s brochure | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor | HM | Glossary - monitor | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file | HM | Glossary - patient/subject file | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product | HM | Glossary - pharmaceutical product | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator | HM | Glossary - principal investigator | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol | HM | Glossary - protocol | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data | HM | Glossary - raw data | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event | HM | Glossary - serious adverse event | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor | HM | Glossary - sponsor | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation | HM | Glossary - validation | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data | HM | Glossary - verification (validation) of data | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness | HM | Glossary - witness | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78 | G | Page 78 | EN | WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 |
