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List of results

• Document:WMA Declaration of Helsinki 2024  + (Declaration of Helsinki)
• Document:DEU Deutsches Ärzteblatt 45849  + (Deutsches Ärzteblatt)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (Directive 2001/20/EC)
• Document:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12  + (Directive 2001/83/EC - Community code relating to medicinal products for human use)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (Directive 90/385/EEC)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (Directive 93/42/EEC)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (Directive 98/79/EC)
• Document:EU EMA Guidelines -  + (EMA Guidelines)
• Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022  + (EMA/298712/2022 - Complex clinical trials – Questions and answers)
• Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017  + (EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site)
• Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021  + (EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol)
• Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022  + (EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units)
• Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023  + (EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials)
• Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023  + (EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022)
• Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022  + (EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE)
• Document:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018  + (EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic))
• Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005  + (EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (ENCePP - Guide on Methodological Standards in Pharmacoepidemiology)
• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  + (Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19)
• Document:EU EudraLex – Volume 10 -  + (EudraLex – Volume 10)
• Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011  + (Eudralex - volume 4 GMP Guidelines Annex 11)
• Document:EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011  + (Eudralex - volume 4 GMP Guidelines Chapter 4)
• Document:EUR European Bioethics Convention 1997  + (European Bioethics Convention)
• Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838  + (European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025)
• Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998  + (Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure)

• Document:AUT FAQ - COVID-19 Studien 15-Mar-2021  + (FAQ - COVID-19 Studien)

• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (FD&C Act - Federal Food, Drug, and Cosmetic Act)
• Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018  + (FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry)
• Document:USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3  + (FDA - HUMAN DRUG CGMP NOTES)
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  + (FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection)
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  + (FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  + (FDA Guidance for Industry - Computerized Systems Used in Clinical Trials)
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  + (FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations)
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  + (FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency)
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  + (FDA Guidance for Industry - Electronic Source Data in Clinical Investigations)
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  + (FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators)
• Document:USA FDA Information - Observations and citations 20-Mar-2024  + (FDA Information - Observations and citations)
• Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020  + (GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL)
• Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022  + (GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC)
• 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)