Pages that link to "Template:DocumentData"

The following pages link to Template:DocumentData:

Displaying 50 items.

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 69 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal product (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2. (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. (transclusion) (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Compliance (in relation to trials) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction (transclusion) (← links)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-003 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.110 (b) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70 (transclusion) (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.119 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3 (transclusion) (← links)
• 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 (transclusion) (← links)
• Reference:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 52 (transclusion) (← links)
• 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 (transclusion) (← links)
• 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 (transclusion) (← links)
• 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 (transclusion) (← links)
• 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 (transclusion) (← links)
• 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 (transclusion) (← links)
• 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 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A (transclusion) (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Who should notify (transclusion) (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution (transclusion) (← links)
• 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 (transclusion) (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported (transclusion) (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I (transclusion) (← links)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II (transclusion) (← links)
• Reference:USA FDA Information - Observations and citations 20-Mar-2024 - (transclusion) (← links)