Pages that link to "Template:DocumentBox"

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• Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) (transclusion) (← links)
• Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a) (transclusion) (← links)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) (transclusion) (← links)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) (transclusion) (← links)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 (transclusion) (← links)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 (transclusion) (← links)
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I (transclusion) (← links)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) - (transclusion) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5 (transclusion) (← links)
• Reference:ICH ICH E9 Guideline 1998 III (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1 (transclusion) (← links)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process (transclusion) (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. (transclusion) (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 (transclusion) (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 - (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 70 (transclusion) (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6 (transclusion) (← links)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1 (transclusion) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) (transclusion) (← links)
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 (transclusion) (← links)
• Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 - (transclusion) (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3 (transclusion) (← links)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2 (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3 (transclusion) (← links)
• Reference:INT ISPE - GPP Revision 3 (2015) - (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 (transclusion) (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble (transclusion) (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6 (transclusion) (← links)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9) (transclusion) (← links)