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• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)  + (III. Annex 1 3.16.1 (g))
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution  + (III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1  + (III. Annex 1 3.17.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5  + (III. Annex 1 3.5)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6  + (III. Annex 1 3.6)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8  + (III. Annex 1 3.8)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9  + (III. Annex 1 3.9)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3  + (III. Annex 1 3.9.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4  + (III. Annex 1 4)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1  + (III. Annex 1 4.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1  + (III. Annex 1 4.2.1)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4  + (III. Annex 1 4.2.3 - 4.2.4)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3  + (III. Annex 1 4.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3  + (III. Annex 1 4.3.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4  + (III. Annex 1 4.3.4)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8  + (III. Annex 1 4.3.8)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B.  + (III. B.)
• Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 IRAS  + (IRAS)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV  + (IV)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.  + (IV A.)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence  + (IV A. Adherence)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct  + (IV A. Conduct)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification  + (IV A. Verification)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.  + (IV.)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation  + (Introduction ; III. B. ; Evaluation)

• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.  + (Introduction ; III. B. ; IV.)

• Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1  + (L5311-1)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3  + (Leitlinie 1 1.1 ; 1.3)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2  + (Leitlinie 1 1.2)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 10  + (Leitlinie 10)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11  + (Leitlinie 11)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2  + (Leitlinie 2)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3  + (Leitlinie 3)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10  + (Leitlinie 3 3.10)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6  + (Leitlinie 3 3.3 - 3.6)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7  + (Leitlinie 3 3.7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9  + (Leitlinie 3 3.9)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4  + (Leitlinie 4)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5  + (Leitlinie 5)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1  + (Leitlinie 6 6.1)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3  + (Leitlinie 6 6.3)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4  + (Leitlinie 6 6.4)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7  + (Leitlinie 6 6.5 - 6.7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8  + (Leitlinie 6 6.8)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7  + (Leitlinie 7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8  + (Leitlinie 8)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 8.4  + (Leitlinie 8 8.4)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9  + (Leitlinie 9)
• Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A  + (N/A)
• Reference:USA NIH - Glossary 27-May-2025 Observational study  + (Observational study)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process  + (Overview of the Clinical Research Process)