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- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 38 + (HM)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. (p) + (HM)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 27 + (HM)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 5 (5) + (HM)
- Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (c) + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45 + (HM)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3 + (HM)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58 + (HM)
- Reference:DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c) + (HM)
- Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4 + (HM)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002 + (HM)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report + (HM)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16 + (HM)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4 + (HM)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) + (HM)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) + (HM)
- Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 - + (HM)
- Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - + (HM)
- Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - + (HM)
- Reference:INT ISPE - GPP Revision 3 (2015) - + (INS)
- Reference:INT ISPE - GPP Revision 3 (2015) II. + (INS)
- Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3 + (INS)
- Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - + (INS)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 70 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble + (IVD)
- Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8) + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 – 7 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 69 + (IVD)
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8 + (IVD)
