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• Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 -  + (11:50:35, 16 July 2026)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 37 Paragraph 4  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 5  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7  + (11:50:36, 16 July 2026)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.  + (11:50:36, 16 July 2026)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3  + (11:50:36, 16 July 2026)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42b  + (11:50:36, 16 July 2026)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003  + (11:50:36, 16 July 2026)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3  + (11:50:36, 16 July 2026)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4)  + (11:50:36, 16 July 2026)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4)  + (11:50:36, 16 July 2026)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NIS  + (11:50:36, 16 July 2026)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start  + (11:50:36, 16 July 2026)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7  + (11:50:36, 16 July 2026)
• Reference:GBR HRA - Ending your project 28-Jan-2025 -  + (11:50:36, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d)  + (11:50:36, 16 July 2026)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3)  + (11:50:36, 16 July 2026)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (6)  + (11:50:36, 16 July 2026)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002  + (11:50:36, 16 July 2026)
• Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.40  + (11:50:36, 16 July 2026)
• Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.44  + (11:50:36, 16 July 2026)
• Reference:USA 42 CFR Part 11 09-Apr-2025 § 11.54  + (11:50:36, 16 July 2026)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 36  + (11:50:36, 16 July 2026)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.17  + (11:50:36, 16 July 2026)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 16  + (11:50:36, 16 July 2026)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5  + (11:50:36, 16 July 2026)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 8.4  + (11:50:36, 16 July 2026)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 10  + (11:50:36, 16 July 2026)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11  + (11:50:36, 16 July 2026)

• Glossary:TAG-00001-Med-rzn  + (11:50:37, 16 July 2026)
• Glossary:TAG-00002-Rad-esA  + (11:50:37, 16 July 2026)
• Glossary:TAG-00003-Adv-cht  + (11:50:37, 16 July 2026)
• Glossary:TAG-00004-Ser-ege  + (11:50:37, 16 July 2026)
• Glossary:TAG-00005-Imm-ngP  + (11:50:37, 16 July 2026)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2  + (11:50:37, 16 July 2026)
• Reference:DEU Deutsches Ärzteblatt 45849 -  + (11:50:37, 16 July 2026)
• Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 -  + (11:50:37, 16 July 2026)
• Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 -  + (11:50:37, 16 July 2026)
• Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 -  + (11:50:37, 16 July 2026)
• Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 -  + (11:50:37, 16 July 2026)
• Reference:GBR MHRA GCP Inspection Dossier template V7.0 -  + (11:50:37, 16 July 2026)
• Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 -  + (11:50:37, 16 July 2026)
• Reference:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und  + (11:50:37, 16 July 2026)

• Glossary:TAG-00006-Out-Sek  + (11:50:38, 16 July 2026)
• Glossary:TAG-00007-Cli-lin  + (11:50:38, 16 July 2026)
• Glossary:TAG-00008-Cli-ngK  + (11:50:38, 16 July 2026)
• Glossary:TAG-00009-Low-gra  + (11:50:38, 16 July 2026)
• Glossary:TAG-00010-Non-Stu  + (11:50:38, 16 July 2026)
• Glossary:TAG-00011-Inv-tud  + (11:50:39, 16 July 2026)
• Glossary:TAG-00012-Aut-esP  + (11:50:39, 16 July 2026)
• Glossary:TAG-00013-Adv-art  + (11:50:39, 16 July 2026)
• Glossary:TAG-00014-Aux-kat  + (11:50:39, 16 July 2026)
• Glossary:TAG-00015-Aut-sHi  + (11:50:39, 16 July 2026)
• Glossary:TAG-00016-Nor-Rou  + (11:50:39, 16 July 2026)
• Glossary:TAG-00017-Spo-die  + (11:50:40, 16 July 2026)
• Glossary:TAG-00018-Inv-die  + (11:50:40, 16 July 2026)
• Glossary:TAG-00019-Pri-Prü  + (11:50:41, 16 July 2026)
• Glossary:TAG-00020-Cli-nit  + (11:50:49, 16 July 2026)
• Glossary:TAG-00021-Sub-rin  + (11:50:49, 16 July 2026)
• Glossary:TAG-00022-Stu-erS  + (11:50:49, 16 July 2026)
• Glossary:TAG-00023-Stu-chw  + (11:50:49, 16 July 2026)