User contributions for Gxplex admin

29 June 2026

• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:GBR MHRA GCP Inspection Dossier template V7.0 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:DEU Deutsches Ärzteblatt 45849 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m 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 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WMA Declaration of Helsinki 2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO World Health Organization - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO - ICD 11 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO - Guidance for best practices for clinical trials 2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:N.A. SPIRIT 2013 - Chan et al. 2013 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:N.A. Article from Mora et al. 2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:INT Nuremberg Code 1947 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:INT ISPE - GPP Revision 3 (2015) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:IMDRF IMDRF – Guidelines - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH Guidelines - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E9 Guideline 1998 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E8 Guideline R1 (2021) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E7 Guideline 1993 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E6 Guideline R3 (2025) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E3 Guideline 1995 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E2F Guideline 2010 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E2A Guideline 1994 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E21 Concept paper 2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E19 Guideline 2022 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:ICH ICH E11 Guideline R1 (2017) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:CIOMS CIOMS Publications - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA U.S. Code Title 21 30-Sep-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA Recognized Consensus Standards N.A. 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA NIH - SCORE Manual N.A. 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA FDA Information - Observations and citations 20-Mar-2024 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA NIH - Glossary 27-May-2025 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 1 revision imported