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- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7 + (TAG-00306-Dat-nDa ++ TAG-00343-Doc-ten ++ TAG-00095-Sto-ung ++ TAG-00010-Non-Stu)
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 + (TAG-00307-Int-gsu ++ TAG-00145-Ran-ute ++ TAG-00123-Bli-ppe ++ TAG-00127-Com-meC)
- Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction + (TAG-00309-Rea-eal ++ TAG-00129-Dat-ali ++ TAG-00008-Cli-ngK)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9 + (TAG-00312-Imp-isi ++ TAG-00029-Inf-rte ++ TAG-00030-Inf-onu ++ TAG-00028-Leg-ich)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness + (TAG-00312-Imp-isi ++ TAG-00244-Def-ini ++ TAG-00029-Inf-rte ++ TAG-00149-Sig-nds)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g) + (TAG-00314-Unb-ung ++ TAG-00123-Bli-ppe ++ TAG-00129-Dat-ali)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3 + (TAG-00314-Unb-ung ++ TAG-00123-Bli-ppe ++ TAG-00025-Sub-mer ++ TAG-00246-Inv-hte)
- Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31 + (TAG-00314-Unb-ung ++ TAG-00292-Eme-ent ++ TAG-00123-Bli-ppe ++ TAG-00246-Inv-hte)
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX VI Section 2.5 No. 17-22 + (TAG-00314-Unb-ung ++ TAG-00292-Eme-ent ++ TAG-00048-Sus-ngV ++ TAG-00246-Inv-hte ++ TAG-00329-Saf-lne)
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001 + (TAG-00316-Del-sbe ++ TAG-00052-Ris-ein ++ TAG-00244-Def-ini)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) + (TAG-00316-Del-sbe ++ TAG-00053-Dev-las ++ TAG-00155-Med-Med)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) + (TAG-00316-Del-sbe ++ TAG-00053-Dev-las ++ TAG-00244-Def-ini)
- Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.104 + (TAG-00316-Del-sbe ++ TAG-00134-Eth-kom)
- Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d) + (TAG-00316-Del-sbe ++ TAG-00134-Eth-kom ++ TAG-00320-Foo-eri)
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) + (TAG-00316-Del-sbe ++ TAG-00155-Med-Med ++ TAG-00244-Def-ini)
- Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) + (TAG-00316-Del-sbe ++ TAG-00155-Med-Med ++ TAG-00340-Req-nfo)
- Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a) + (TAG-00316-Del-sbe ++ TAG-00220-Inv-agn ++ TAG-00244-Def-ini)
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (f) + (TAG-00316-Del-sbe ++ TAG-00244-Def-ini)
- Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (i) + (TAG-00316-Del-sbe ++ TAG-00244-Def-ini)
- Reference:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2 + (TAG-00316-Del-sbe ++ TAG-00244-Def-ini ++ TAG-00319-Dif-ers)
- Reference:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2 + (TAG-00316-Del-sbe ++ TAG-00244-Def-ini ++ TAG-00319-Dif-ers)
- Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 + (TAG-00316-Del-sbe ++ TAG-00244-Def-ini ++ TAG-00320-Foo-eri)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3 + (TAG-00316-Del-sbe ++ TAG-00319-Dif-ers ++ TAG-00001-Med-rzn)
- Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4 + (TAG-00316-Del-sbe ++ TAG-00319-Dif-ers ++ TAG-00001-Med-rzn ++ TAG-00057-Com-deR)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5 + (TAG-00317-Obj-set ++ TAG-00304-Pri-tSt ++ TAG-00201-Cli-eSt ++ TAG-00077-Inc-gsk)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2 + (TAG-00317-Obj-set ++ TAG-00338-Met-odi ++ TAG-00010-Non-Stu)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 89 + (TAG-00318-Fun-nzi)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 24 + (TAG-00318-Fun-nzi)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 38 + (TAG-00318-Fun-nzi)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 37 + (TAG-00318-Fun-nzi ++ TAG-00319-Dif-ers)
- Reference:FRA Guide de légistique 07-Feb-2024 - + (TAG-00318-Fun-nzi ++ TAG-00319-Dif-ers)
- Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 - + (TAG-00318-Fun-nzi ++ TAG-00319-Dif-ers)
- Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A + (TAG-00318-Fun-nzi ++ TAG-00340-Req-nfo)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55 + (TAG-00318-Fun-nzi ++ TAG-00340-Req-nfo)
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34 + (TAG-00318-Fun-nzi ++ TAG-00340-Req-nfo)
- Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe + (TAG-00319-Dif-ers ++ TAG-00046-Ser-sSc ++ TAG-00259-AEs-ten ++ TAG-00045-Adv-hte)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3 + (TAG-00319-Dif-ers ++ TAG-00316-Del-sbe ++ TAG-00010-Non-Stu ++ TAG-00008-Cli-ngK ++ TAG-00057-Com-deR)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) + (TAG-00320-Foo-eri ++ TAG-00017-Spo-die ++ TAG-00018-Inv-die ++ TAG-00343-Doc-ten)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.4 list of investigators + (TAG-00320-Foo-eri ++ TAG-00018-Inv-die ++ TAG-00328-Com-egu ++ TAG-00343-Doc-ten)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001 + (TAG-00320-Foo-eri ++ TAG-00057-Com-deR ++ TAG-00204-Cli-tbe ++ TAG-00276-Mar-inh)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-002 + (TAG-00320-Foo-eri ++ TAG-00057-Com-deR ++ TAG-00204-Cli-tbe ++ TAG-00276-Mar-inh)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.42 + (TAG-00320-Foo-eri ++ TAG-00134-Eth-kom ++ TAG-00340-Req-nfo ++ TAG-00036-Sta-ung)
- Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) + (TAG-00320-Foo-eri ++ TAG-00245-Spo-ten ++ TAG-00111-Agr-chr ++ TAG-00155-Med-Med ++ TAG-00061-Cli-rtr)
- Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22 + (TAG-00320-Foo-eri ++ TAG-00340-Req-nfo ++ TAG-00001-Med-rzn)
- Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.6 + (TAG-00320-Foo-eri ++ TAG-00343-Doc-ten ++ TAG-00271-Ret-Arc ++ TAG-00018-Inv-die ++ TAG-00017-Spo-die)
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 + (TAG-00321-Age-pro ++ TAG-00046-Ser-sSc ++ TAG-00279-Hea-rFr ++ TAG-00155-Med-Med ++ TAG-00134-Eth-kom)
- Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1 + (TAG-00321-Age-pro ++ TAG-00057-Com-deR ++ TAG-00177-Ben-koB)
- Reference:FRA AEC DOC010 V.04 01-Jun-2018 - + (TAG-00321-Age-pro ++ TAG-00059-Reg-lat ++ TAG-00264-Eud-lin ++ TAG-00008-Cli-ngK ++ TAG-00001-Med-rzn)
- Reference:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 - + (TAG-00321-Age-pro ++ TAG-00155-Med-Med ++ TAG-00059-Reg-lat)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5 + (TAG-00328-Com-egu ++ TAG-00033-Pro-oto ++ TAG-00043-Goo-tek ++ TAG-00041-Ame-run)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. + (TAG-00328-Com-egu ++ TAG-00033-Pro-oto ++ TAG-00043-Goo-tek ++ TAG-00134-Eth-kom)
- Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5 + (TAG-00328-Com-egu ++ TAG-00033-Pro-oto ++ TAG-00246-Inv-hte ++ TAG-00043-Goo-tek ++ TAG-00111-Agr-chr)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 + (TAG-00328-Com-egu ++ TAG-00203-Cli-lin ++ TAG-00019-Pri-Prü ++ TAG-00150-Sou-eUr ++ TAG-00246-Inv-hte)