Pages that link to "Template:ReferenceData"

The following pages link to Template:ReferenceData:

Displaying 50 items.

• Reference:USA 45 CFR Part 46 09-Apr-2025 Subpart D (transclusion) (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V. (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3 (transclusion) (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section K No. 59-60 (transclusion) (← links)
• Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9 (transclusion) (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2 (transclusion) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3. (transclusion) (← links)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 - (transclusion) (← links)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002 (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.1 (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 7 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 5 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001 (transclusion) (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (i) (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) (transclusion) (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c) (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Blinding/Masking (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Randomisation (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.11 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1 (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.6 (transclusion) (← links)
• Reference:ICH ICH E9 Guideline 1998 2.3 (transclusion) (← links)
• Reference:ICH ICH E9 Guideline 1998 2.3.1 (transclusion) (← links)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Double-Dummy (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2 (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction (transclusion) (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section D No. 8 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 (transclusion) (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 (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 - Randomisation (transclusion) (← links)
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (4) - (5) (transclusion) (← links)
• Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.10 (b) (5) (transclusion) (← links)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct (transclusion) (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational Product (transclusion) (← links)