| | Scope | Document part | Language | Document |
|---|
| AUT MPG – Medizinproduktegesetz 26-May-2022 § 22 | MD | § 22 | DE | AUT MPG – Medizinproduktegesetz 26-May-2022 |
| AUT Question - BASG 11-Feb-2025 - | G | - | DE | AUT Question - BASG 11-Feb-2025 |
| CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20 | G | Page 20 | EN | CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41 | HM | § 41 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a | G | § 41a | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b | G | § 41b | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c | G | § 41c | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3 | NIS | Leitlinie 1
1.1 ; 1.3 | DE | DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.5 | NIS | 2.7.5 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10 | G | § 10 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11 | G | § 11 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4 | G | § 4 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5 | G | § 5 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 6 | G | § 6 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7 | G | § 7 | DE | DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 | MD | § 33 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 35 | MD | § 35 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 | MD | § 40 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 | MD | § 41 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48 | MD | § 48 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 49 | MD | § 49 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50 | MD | § 50 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 | MD | § 55 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 | MD | § 59 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 4 | G | Article 4 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20 | G | Article R1123-20 | FR | FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 |
| FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1 | G | Article R1123-20-1 | FR | FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 |
| FRA SI RIPH 2G - Website 16-May-2025 - | MD | - | FR | FRA SI RIPH 2G - Website 16-May-2025 |
| GBR HRA - Ending your project 28-Jan-2025 - | G | - | EN | GBR HRA - Ending your project 28-Jan-2025 |
| GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates | G | Templates | EN | GBR IRAS - Integrated Research Application System 28-Jan-2025 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12 | HM | Article 11 - 12 | 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 14 | HM | Article 14 | 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 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 15 (5) (d) | HM | Article 15
(5) (d) | 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 15 (5) (k)-(l) | HM | Article 15
(5) (k)-(l) | 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 15 (7) - (10) | HM | Article 15
(7) - (10) | 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 16 | HM | Article 16 | 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 25 | HM | Article 25 | 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 5-6 | HM | Article 5-6 | 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 7-10 | HM | Article 7-10 | 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 Schedule 3 Part 1 1. | HM | Schedule 3
Part 1
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 Schedule 3 Part 1 1. ; 3. | HM | Schedule 3
Part 1
1. ; 3. | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| 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) III. Annex 1 1 | G | III. Annex 1
1 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13 | G | III. Annex 1
2.13 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 | G | III. Annex 1
2.4.2 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8 | G | III. Annex 1
3.8 | EN | ICH ICH E6 Guideline R3 (2025) |
| 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 5.7 | MD | 5.7 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| 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 50 09-Apr-2025 § 50.3 (i) | G | § 50.3
(i) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 - | G | - | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 Subpart B | G | Subpart B | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 Subpart C | G | Subpart C | EN | USA 21 CFR Part 56 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 56 09-Apr-2025 § 56.103 | G | § 56.103 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.104 | G | § 56.104 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d) | G | § 56.104
(d) | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.105 | G | § 56.105 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.109 | G | § 56.109 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1) | G | § 56.110
(a) - (b) (1) | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) | G | § 56.110
(b) (2) | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112 | G | § 56.111
-
§56.112 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.113-001 | G | § 56.113 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 56 09-Apr-2025 § 56.113-002 | G | § 56.113 | EN | USA 21 CFR Part 56 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 Subpart D | MD | Subpart D | 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 (t) | MD | § 812.3
(t) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.42 | MD | § 812.42 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 Subpart B | G | Subpart B | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 Subpart E | G | Subpart E | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.104 | G | § 46.104 | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112 | G | § 46.107 - § 46.112 | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.113 | G | § 46.113 | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.115 | G | § 46.115 | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA 45 CFR Part 46 09-Apr-2025 § 46.124 | G | § 46.124 | EN | USA 45 CFR Part 46 09-Apr-2025 |
| USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - | G | - | EN | USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 |
| USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV. | G | III A. ; IV. | EN | USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 |
| USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - | HM | - | EN | USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation | HM | 3.2 - Consultation | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction | HM | 3.2 - Introduction | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility | HM | 3.2 - Responsibility | 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 |
| WMA Declaration of Helsinki 2024 Paragraph 23 | G | Paragraph 23 | EN | WMA Declaration of Helsinki 2024 |
| WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval | G | Paragraph 23 - Amendment approval | EN | WMA Declaration of Helsinki 2024 |
| WMA Declaration of Helsinki 2024 Paragraph 23 - Final report | G | Paragraph 23 - Final report | EN | WMA Declaration of Helsinki 2024 |
| WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight | G | Paragraph 23 - Oversight | EN | WMA Declaration of Helsinki 2024 |
