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- Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 - + (-)
- Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 - + (-)
- Reference:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 - + (-)
- Reference:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 - + (-)
- Reference:IMDRF IMDRF – Guidelines - - + (-)
- Reference:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017) - + (-)
- Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 - + (-)
- Reference:GBR NHS: Records Management Code of Practice 07-Aug-2023 - + (-)
- Reference:AUT Question - BASG 11-Feb-2025 - + (-)
- Reference:ICH ICH E3 Guideline 1995 - + (-)
- Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 - + (-)
- Reference:GBR HRA - Ending your project 28-Jan-2025 - + (-)
- Reference:DEU Deutsches Ärzteblatt 45849 - + (-)
- Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 - + (-)
- Reference:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 - + (-)
- Reference:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 - + (-)
- Reference:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 - + (-)
- Reference:GBR MHRA GCP Inspection Dossier template V7.0 - + (-)
- Reference:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 - + (-)
- 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 + (-)
- Reference:ICH ICH E2F Guideline 2010 1 + (1)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001 + (1.1)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002 + (1.1)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research + (1.1 - Clinical Research)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS + (1.1 - NIS)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials + (1.1 - Platform, basket and umbrella trials)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2 + (1.2)
- Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3 + (1.3)
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3 + (1.3)
- Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4 + (1.4)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1.4 + (1.4)
- Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 + (1.4)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.1 + (10.1)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.2 + (10.2)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.3 + (10.3)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3 + (10.3)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 + (10.4)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.6 + (10.6)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 + (10.7)
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e) + (10.7 (e))
- Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.8 + (10.8)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11 + (11)
- Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d) + (11 d))
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 + (11.2)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 13 + (13)
- Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 + (14)
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 2 + (2)
- Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. + (2.)
- Reference:ICH ICH E21 Concept paper 2023 2. + (2.)
- Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001 + (2.)
- Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 + (2.)