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- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 +
- Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22 +
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3. +
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 +
- Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5. +
- Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 +
- Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35 +
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17 +
- Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X +
- Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002 +
- Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002 +
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4 +
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 +
- Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5) +
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1) +
- Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation +
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 +
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 +
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002 +
- Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout +