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- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10 + (3.4.2)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3 + (3.4.2)
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3 + (3.4.2)
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2 + (3.4.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6 + (3.4.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 + (3.4.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 + (3.4.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002 + (3.4.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9 + (3.4.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001 + (3.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51 + (3.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66 + (3.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67 + (3.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 + (3.4.2)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 + (3.4.2)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product + (3.4.2)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. + (3.4.2)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. + (3.4.2)
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) + (3.4.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) + (3.4.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) + (3.4.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) + (3.4.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 + (3.4.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) + (3.4.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) + (3.4.2)
- Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) + (4.1.1)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 + (4.1.1)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 + (4.1.1)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction + (4.1.1)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 + (4.1.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 + (4.1.1)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 + (4.1.1)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. + (4.1.1)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) + (4.1.1)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) + (4.1.1)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) + (4.1.1)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 + (4.1.2)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 + (4.1.2)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70 + (4.1.2)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.119 + (4.1.2)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 + (4.1.3)
- Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance + (4.1.3)
- Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - + (4.1.3)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 + (4.1.4)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1 + (4.1.4)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 + (4.1.4)
- Reference: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 + (4.1.4)
- Reference: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 + (4.1.4)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 + (4.1.4)
- Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I + (4.1.4)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A + (4.1.4)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify + (4.1.4)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution + (4.1.4)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made + (4.1.4)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported + (4.1.4)
- Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I + (4.1.4)