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List of results

• 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:ICH ICH E2F Guideline 2010  + (2010)
• 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)
• Document:DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023  + (22-Dec-2023)
• Document:FRA Infographie - La hiérarchie des normes 22-Mar-2024  + (22-Mar-2024)
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (23-Jan-2019)
• Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022  + (23-May-2022)
• Document:AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021  + (23-Nov-2021)
• Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021  + (24-Apr-2021)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (25-Apr-2017)
• Document:AUT MPG – Medizinproduktegesetz 26-May-2022  + (26-May-2022)
• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (27-May-2014 Preamble)
• Document:USA NIH - Glossary 27-May-2025  + (27-May-2025)
• Document:GBR Clinical Trial toolkit 28-Jan-2025  + (28-Jan-2025)
• Document:GBR HRA - Ending your project 28-Jan-2025  + (28-Jan-2025)
• Document:GBR IRAS - Integrated Research Application System 28-Jan-2025  + (28-Jan-2025)
• Document:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025  + (28-Jan-2025)
• Document:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22  + (28-Jan-22)
• Document:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022  + (28-Jun-2022)
• Document:AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024  + (29-Nov-2024)
• Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024  + (30-Aug-2024)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (30-Sep-2023)
• Document:USA U.S. Code Title 21 30-Sep-2023  + (30-Sep-2023)
• Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020  + (31-Dec-2020)