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List of results
- Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) + (GVP: Module VIII EMA/813938/2011)
- Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024) + (GVP: Module XVI EMA/204715/2012)
- Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 + (Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien)
- Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 + (Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials)
- Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021 + (Guidance Managing clinical trials during Coronavirus (COVID-19))
- Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 + (Guidance - Good clinical practice for clinical trials)
- Document:FRA Guide de légistique 07-Feb-2024 + (Guide de légistique)
- Document:GBR HRA - Ending your project 28-Jan-2025 + (HRA - Ending your project)
- Document:ICH ICH E11 Guideline R1 (2017) + (ICH E11 Guideline)
- Document:ICH ICH E19 Guideline 2022 + (ICH E19 Guideline)
- Document:ICH ICH E21 Concept paper 2023 + (ICH E21 Concept paper)
- Document:ICH ICH E2A Guideline 1994 + (ICH E2A Guideline)
- Document:ICH ICH E2F Guideline 2010 + (ICH E2F Guideline)
- Document:ICH ICH E3 Guideline 1995 + (ICH E3 Guideline)
- Document:ICH ICH E6 Guideline R3 (2025) + (ICH E6 Guideline)
- Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 + (ICH E6 Guideline - Annex 2)
- Document:ICH ICH E7 Guideline 1993 + (ICH E7 Guideline)
- Document:ICH ICH E8 Guideline R1 (2021) + (ICH E8 Guideline)
- Document:ICH ICH E9 Guideline 1998 + (ICH E9 Guideline)
- Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 + (ICH E9 Guideline - Addendum R1)
- Document:ICH ICH Guidelines - + (ICH Guidelines)
- Document:IMDRF IMDRF – Guidelines - + (IMDRF – Guidelines)
- 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 + (INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP)
- Document:GBR IRAS - Integrated Research Application System 28-Jan-2025 + (IRAS - Integrated Research Application System)
- Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 + (ISO 14155 - Clinical investigation of medical devices for human subjects)
- Document:INT ISPE - GPP Revision 3 (2015) + (ISPE - GPP)
- Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024 + (Infographie - La hiérarchie des normes)
- Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 + (Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors)
- Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 + (KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung)
- Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024 + (LekV – Leit-Ethikkommissions-Verordnung)
- Document:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 + (MBO - Berufsordnung der Ärzt:innen)
- Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 + (MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices)
- Document:EU MDCG Guidelines - + (MDCG Guidelines)
- Document:GBR MEDDEV 2.7/3 revision 3 May-2015 + (MEDDEV 2.7/3 revision 3)
- Document:GBR MHRA GCP Inspection Dossier template V7.0 + (MHRA GCP Inspection Dossier template)
- Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 + (MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung)
- Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021 + (MPBetreibV - Medizinprodukte-Betreiberverordnung)
- Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 + (MPDG - Medizinprodukterecht-Durchführungsgesetz)
- Document:AUT MPG – Medizinproduktegesetz 26-May-2022 + (MPG – Medizinproduktegesetz)
- Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 + (Making changes to a research study to manage the impact of COVID-19)
- Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 + (Medicines and Medical Devices Act 2021)
- Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 + (Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training)
- Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 + (NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs)
- Document:GBR NHS: Records Management Code of Practice 07-Aug-2023 + (NHS: Records Management Code of Practice)
- Document:USA NIH - SCORE Manual N.A. + (NIH - SCORE Manual)
- Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 + (NIH - SCORE Manual: Appendix Source Documents Requirements)
- Document:USA NIH - Glossary 27-May-2025 + (NIH - Glossary)
- Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 + (NIHR - National Institute for Health and Care Research)
- Document:GBR National Health Service Act 2006 02-Dec-2019 + (National Health Service Act 2006)
- Document:INT Nuremberg Code 1947 + (Nuremberg Code)
- Document:AUT Question - BASG 11-Feb-2025 + (Question - BASG)