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- Document:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 + (16-May-2025)
- Document:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 + (16-May-2025)
- Document:FRA SI RIPH 2G - Website 16-May-2025 + (16-May-2025)
- Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 + (16-May-2025)
- Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 + (16-Nov-.2021)
- Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 + (16-Oct-2015)
- Document:EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014 + (17-Sep-2014)
- Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023 + (19-Jul-2023)
- Document:INT Nuremberg Code 1947 + (1947)
- Document:ICH ICH E7 Guideline 1993 + (1993)
- Document:ICH ICH E2A Guideline 1994 + (1994)
- Document:ICH ICH E3 Guideline 1995 + (1995)
- Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 + (1995)
- Document:EUR European Bioethics Convention 1997 + (1997)
- Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 + (1998)
- Document:ICH ICH E9 Guideline 1998 + (1998)
- Document:GBR Directive 98/79/EC 20-Dec-2011 + (20-Dec-2011)
- Document:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 + (20-Dez-1988)
- Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 + (20-Jun-12)
- Document:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 + (20-Jun-12)
- Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 + (20-Mar-2023)
- Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 + (20-Mar-2023)
- Document:USA FDA Information - Observations and citations 20-Mar-2024 + (20-Mar-2024)
- Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 + (20-Nov-2019)
- Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 + (2005)
- Document:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 + (2012)
- Document:N.A. SPIRIT 2013 - Chan et al. 2013 + (2013)
- Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 + (2016)
- Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 + (2016)
- Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 + (2020)
- Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 + (2020)
- Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 + (2021)
- Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 + (2021-09-08 00:00:00)
- Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 + (2022)
- Document:ICH ICH E19 Guideline 2022 + (2022)
- Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 + (2023)
- Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 + (2023)
- Document:ICH ICH E21 Concept paper 2023 + (2023)
- Document:N.A. Article from Mora et al. 2023 + (2023)
- Document:WHO WHO - Guidance for best practices for clinical trials 2024 + (2024)
- Document:WMA Declaration of Helsinki 2024 + (2024)
- Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 + (2025-06-30 00:00:00)
- Document:DEU Deutsches Ärzteblatt 45849 + (2025-07-11 00:00:00)
- Document: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 + (2025-07-11 00:00:00)
- Document:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 + (2026-04-02 00:00:00)
- Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 + (21-Apr-2021)
- Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 + (21-Dec-2020)
- Document:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 + (21-Feb-2018)
- Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 + (21-Feb-2021)
- Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 + (21-May-2025)