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• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  +
• Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018  +
• Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022  +
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  +
• Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022  +
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  +
• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  +
• Document:FRA AEC DOC010 V.04 01-Jun-2018  +
• Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025  +
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  +
• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  +
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  +
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  +
• Document:GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447  +
• Document:GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021  +
• Document:GBR HRA - Ending your project 28-Jan-2025  +
• Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015  +
• Document:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021  +
• 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  +
• Document:USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)  +
• Document:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998  +
• Document:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018  +
• Document:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009  +
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007  +
• Document:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015  +
• Document:USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020  +
• Document:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013  +
• Document:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013  +
• Document:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009  +
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  +
• Document:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023  +
• Document:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025  +
• Document:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020  +