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List of results

• 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)
• 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)