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List of results

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34  + (TAG-00029-Inf-rte ++ TAG-00154-Vul-eil ++ TAG-00008-Cli-ngK)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58  + (TAG-00029-Inf-rte ++ TAG-00244-Def-ini ++ TAG-00231-Per-ung ++ TAG-00026-Min-isc ++ TAG-00027-Inc-son ++ TAG-00028-Leg-ich)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent  + (TAG-00029-Inf-rte ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00343-Doc-ten)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.  + (TAG-00029-Inf-rte ++ TAG-00246-Inv-hte ++ TAG-00329-Saf-lne ++ TAG-00320-Foo-eri)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8  + (TAG-00029-Inf-rte ++ TAG-00275-Lay-ndl ++ TAG-00264-Eud-lin ++ TAG-00025-Sub-mer)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3  + (TAG-00029-Inf-rte ++ TAG-00286-Ele-sch ++ TAG-00134-Eth-kom ++ TAG-00032-Inf-ngs ++ TAG-00043-Goo-tek)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.20  + (TAG-00029-Inf-rte ++ TAG-00320-Foo-eri ++ TAG-00340-Req-nfo ++ TAG-00018-Inv-die)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8  + (TAG-00029-Inf-rte ++ TAG-00340-Req-nfo ++ TAG-00025-Sub-mer)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2  + (TAG-00029-Inf-rte ++ TAG-00340-Req-nfo ++ TAG-00025-Sub-mer ++ TAG-00155-Med-Med)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1  + (TAG-00029-Inf-rte ++ TAG-00340-Req-nfo ++ TAG-00028-Leg-ich ++ TAG-00312-Imp-isi ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1  + (TAG-00029-Inf-rte ++ TAG-00340-Req-nfo ++ TAG-00028-Leg-ich ++ TAG-00312-Imp-isi ++ TAG-00231-Per-ung)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1  + (TAG-00029-Inf-rte ++ TAG-00340-Req-nfo ++ TAG-00028-Leg-ich ++ TAG-00312-Imp-isi ++ TAG-00149-Sig-nds)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III.  + (TAG-00030-Inf-onu ++ TAG-00029-Inf-rte ++ TAG-00343-Doc-ten ++ TAG-00134-Eth-kom ++ TAG-00320-Foo-eri)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5  + (TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2  + (TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00231-Per-ung)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5  + (TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00231-Per-ung)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2  + (TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00201-Cli-eSt ++ TAG-00155-Med-Med)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5  + (TAG-00031-Pat-onA ++ TAG-00029-Inf-rte ++ TAG-00028-Leg-ich ++ TAG-00155-Med-Med)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6  + (TAG-00031-Pat-onA ++ TAG-00149-Sig-nds ++ TAG-00029-Inf-rte ++ TAG-00062-Med-tre)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61  + (TAG-00032-Inf-ngs ++ TAG-00029-Inf-rte ++ TAG-00018-Inv-die ++ TAG-00017-Spo-die ++ TAG-00134-Eth-kom)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2  + (TAG-00032-Inf-ngs ++ TAG-00029-Inf-rte ++ TAG-00019-Pri-Prü ++ TAG-00203-Cli-lin ++ TAG-00201-Cli-eSt)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction  + (TAG-00032-Inf-ngs ++ TAG-00029-Inf-rte ++ TAG-00149-Sig-nds ++ TAG-00030-Inf-onu)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001  + (TAG-00032-Inf-ngs ++ TAG-00083-Enr-enr ++ TAG-00029-Inf-rte ++ TAG-00320-Foo-eri)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002  + (TAG-00032-Inf-ngs ++ TAG-00083-Enr-enr ++ TAG-00029-Inf-rte ++ TAG-00320-Foo-eri)
• Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.  + (TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte)
• Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6  + (TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Appendix 2  + (TAG-00033-Pro-oto)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29  + (TAG-00033-Pro-oto)
• Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3  + (TAG-00033-Pro-oto)

• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3  + (TAG-00033-Pro-oto ++ TAG-00010-Non-Stu ++ TAG-00338-Met-odi)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10  + (TAG-00033-Pro-oto ++ TAG-00010-Non-Stu ++ TAG-00343-Doc-ten ++ TAG-00340-Req-nfo)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6)  + (TAG-00033-Pro-oto ++ TAG-00011-Inv-tud ++ TAG-00320-Foo-eri ++ TAG-00340-Req-nfo)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-001  + (TAG-00033-Pro-oto ++ TAG-00025-Sub-mer ++ TAG-00287-Sto-pre ++ TAG-00246-Inv-hte ++ TAG-00011-Inv-tud)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002  + (TAG-00033-Pro-oto ++ TAG-00025-Sub-mer ++ TAG-00287-Sto-pre ++ TAG-00246-Inv-hte ++ TAG-00011-Inv-tud)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B  + (TAG-00033-Pro-oto ++ TAG-00041-Ame-run ++ TAG-00329-Saf-lne ++ TAG-00176-Ris-erh)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2  + (TAG-00033-Pro-oto ++ TAG-00041-Ame-run ++ TAG-00017-Spo-die ++ TAG-00246-Inv-hte)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22  + (TAG-00033-Pro-oto ++ TAG-00051-Eth-ngs ++ TAG-00176-Ris-erh ++ TAG-00340-Req-nfo)
• Reference:N.A. SPIRIT 2013 - Chan et al. 2013 -  + (TAG-00033-Pro-oto ++ TAG-00075-Pub-ich)
• Reference:ICH ICH E6 Guideline R3 (2025) II 7.4  + (TAG-00033-Pro-oto ++ TAG-00076-Fea-ung ++ TAG-00017-Spo-die ++ TAG-00317-Obj-set)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001  + (TAG-00033-Pro-oto ++ TAG-00077-Inc-gsk ++ TAG-00078-Exc-ssk ++ TAG-00201-Cli-eSt ++ TAG-00086-Fol-Fol)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002  + (TAG-00033-Pro-oto ++ TAG-00077-Inc-gsk ++ TAG-00078-Exc-ssk ++ TAG-00201-Cli-eSt ++ TAG-00086-Fol-Fol)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17  + (TAG-00033-Pro-oto ++ TAG-00137-Mon-che ++ TAG-00113-Aud-tQu ++ TAG-00044-Ins-ion ++ TAG-00130-Dir-gDi)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No.17 ; No. 22  + (TAG-00033-Pro-oto ++ TAG-00145-Ran-ute ++ TAG-00123-Bli-ppe ++ TAG-00314-Unb-ung ++ TAG-00098-IMP-tik)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process  + (TAG-00033-Pro-oto ++ TAG-00151-Sta-rat ++ TAG-00137-Mon-che ++ TAG-00134-Eth-kom ++ TAG-00135-Inv-ntr ++ TAG-00341-Res-ben)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol  + (TAG-00033-Pro-oto ++ TAG-00244-Def-ini ++ TAG-00338-Met-odi ++ TAG-00317-Obj-set)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.  + (TAG-00033-Pro-oto ++ TAG-00302-Ada-die ++ TAG-00055-Stu-ngs ++ TAG-00011-Inv-tud)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8  + (TAG-00033-Pro-oto ++ TAG-00304-Pri-tSt ++ TAG-00133-Ind-rhe ++ TAG-00041-Ame-run)
• Reference:INT ISPE - GPP Revision 3 (2015) II.  + (TAG-00033-Pro-oto ++ TAG-00340-Req-nfo)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3  + (TAG-00033-Pro-oto ++ TAG-00343-Doc-ten ++ TAG-00073-Arc-arc ++ TAG-00340-Req-nfo)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex B  + (TAG-00034-Inv-Bro)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5)  + (TAG-00034-Inv-Bro ++ TAG-00011-Inv-tud ++ TAG-00320-Foo-eri ++ TAG-00017-Spo-die)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4  + (TAG-00034-Inv-Bro ++ TAG-00011-Inv-tud ++ TAG-00095-Sto-ung ++ TAG-00035-Man-odu)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure  + (TAG-00034-Inv-Bro ++ TAG-00244-Def-ini)