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• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)  +
• Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B  +
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation  +
• Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4  +
• Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases  +
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21  +
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85  +
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3  +
• Reference:ICH ICH E8 Guideline R1 (2021) -  +
• Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5  +
• Reference:ICH ICH E9 Guideline 1998 III  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1  +
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process  +
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.  +
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1  +
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -  +
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)  +
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126  +
• Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 -  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee  +
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10  +