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List of results
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 - + (TAG-00286-Ele-sch ++ TAG-00149-Sig-nds)
- Reference:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019 - + (TAG-00286-Ele-sch ++ TAG-00149-Sig-nds ++ TAG-00340-Req-nfo)
- Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 + (TAG-00286-Ele-sch ++ TAG-00149-Sig-nds ++ TAG-00340-Req-nfo ++ TAG-00165-Sys-omb)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) + (TAG-00286-Ele-sch ++ TAG-00149-Sig-nds ++ TAG-00244-Def-ini ++ TAG-00320-Foo-eri)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.70 + (TAG-00286-Ele-sch ++ TAG-00149-Sig-nds ++ TAG-00064-Ele-eUn ++ TAG-00129-Dat-ali)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200 + (TAG-00286-Ele-sch ++ TAG-00165-Sys-omb ++ TAG-00320-Foo-eri)
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2 + (TAG-00286-Ele-sch ++ TAG-00244-Def-ini)
- Reference:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 Article 3 Paragraph 10 + (TAG-00286-Ele-sch ++ TAG-00244-Def-ini)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.300 + (TAG-00286-Ele-sch ++ TAG-00294-Rem-gFe ++ TAG-00165-Sys-omb)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50 + (TAG-00286-Ele-sch ++ TAG-00340-Req-nfo ++ TAG-00064-Ele-eUn)
- Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 + (TAG-00286-Ele-sch ++ TAG-00340-Req-nfo ++ TAG-00320-Foo-eri)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001 + (TAG-00287-Sto-pre ++ TAG-00033-Pro-oto ++ TAG-00055-Stu-ngs)
- Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002 + (TAG-00287-Sto-pre ++ TAG-00033-Pro-oto ++ TAG-00055-Stu-ngs)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5 + (TAG-00288-Qua-nag ++ TAG-00055-Stu-ngs ++ TAG-00144-Qua-gew)
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 + (TAG-00289-Ris-Qua ++ TAG-00288-Qua-nag ++ TAG-00176-Ris-erh)
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 + (TAG-00289-Ris-Qua ++ TAG-00288-Qua-nag ++ TAG-00176-Ris-erh ++ TAG-00008-Cli-ngK)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) + (TAG-00292-Eme-ent ++ TAG-00123-Bli-ppe ++ TAG-00031-Pat-onA ++ TAG-00201-Cli-eSt)
- Reference:ICH ICH E9 Guideline 1998 2.3.1 + (TAG-00292-Eme-ent ++ TAG-00314-Unb-ung ++ TAG-00123-Bli-ppe ++ TAG-00062-Med-tre)
- Reference:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 - + (TAG-00295-Rem-erp ++ TAG-00065-Sou-nüb ++ TAG-00322-Fed-imi ++ TAG-00323-Pau-Imp ++ TAG-00029-Inf-rte)
- Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 + (TAG-00295-Rem-erp ++ TAG-00065-Sou-nĂĽb ++ TAG-00025-Sub-mer ++ TAG-00334-Tra-ngP ++ TAG-00176-Ris-erh)
- Reference:AUT FAQ - COVID-19 Studien 15-Mar-2021 - + (TAG-00295-Rem-erp ++ TAG-00065-Sou-nĂĽb ++ TAG-00326-Fed-wes ++ TAG-00150-Sou-eUr)
- Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) + (TAG-00295-Rem-erp ++ TAG-00065-Sou-nĂĽb ++ TAG-00138-Rem-oni ++ TAG-00329-Saf-lne ++ TAG-00025-Sub-mer)
- Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 - + (TAG-00295-Rem-erp ++ TAG-00138-Rem-oni ++ TAG-00063-Dat-per ++ TAG-00031-Pat-onA ++ TAG-00017-Spo-die)
- Reference:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 Q15 + (TAG-00295-Rem-erp ++ TAG-00138-Rem-oni ++ TAG-00320-Foo-eri ++ TAG-00150-Sou-eUr ++ TAG-00137-Mon-che)
- Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 - + (TAG-00295-Rem-erp ++ TAG-00321-Age-pro ++ TAG-00063-Dat-per ++ TAG-00291-Qua-tsk ++ TAG-00143-Non-abw)
- Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES + (TAG-00301-Cli-eII)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases + (TAG-00301-Cli-eII ++ TAG-00008-Cli-ngK ++ TAG-00279-Hea-rFr)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 + (TAG-00301-Cli-eII ++ TAG-00201-Cli-eSt ++ TAG-00011-Inv-tud)
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 + (TAG-00301-Cli-eII ++ TAG-00320-Foo-eri ++ TAG-00017-Spo-die ++ TAG-00001-Med-rzn)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials + (TAG-00302-Ada-die ++ TAG-00033-Pro-oto ++ TAG-00277-Pla-par ++ TAG-00055-Stu-ngs)
- Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary + (TAG-00302-Ada-die ++ TAG-00033-Pro-oto ++ TAG-00244-Def-ini ++ TAG-00011-Inv-tud)
- Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4 + (TAG-00303-Int-lan ++ TAG-00129-Dat-ali ++ TAG-00123-Bli-ppe ++ TAG-00133-Ind-rhe)
- Reference:ICH ICH E9 Guideline 1998 4.5 + (TAG-00303-Int-lan ++ TAG-00287-Sto-pre ++ TAG-00038-Ear-tig ++ TAG-00329-Saf-lne)
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7 + (TAG-00306-Dat-nDa ++ TAG-00010-Non-Stu ++ TAG-00343-Doc-ten)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.8 + (TAG-00306-Dat-nDa ++ TAG-00124-Cas-PrĂĽ ++ TAG-00025-Sub-mer)
- 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)