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Property:RefScope

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Text

Applicable scope of this reference.

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Showing 20 pages using this property.
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) +
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GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) +
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GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B +
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USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation +
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USA 21 CFR Part 320 09-Apr-2025 § 320.22 +
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DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2 +
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DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3 +
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DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4 +
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ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases +
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USA 21 CFR Part 312 09-Apr-2025 § 312.21 +
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USA 21 CFR Part 312 09-Apr-2025 § 312.85 +
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ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 +
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ICH ICH E8 Guideline R1 (2021) - +
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ICH ICH E8 Guideline R1 (2021) 3.3.5 +
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ICH ICH E9 Guideline 1998 III +
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WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1 +
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WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process +
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EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. +
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