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• 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)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20  + (Page 20)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22  + (Page 22)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23  + (Page 23)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 28-29  + (Page 28-29)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF  + (Page 3 - CRF)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note  + (Page 3 - Note)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 31  + (Page 31)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 44  + (Page 44)
• Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6  + (Page 6)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61  + (Page 60-61)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 78  + (Page 78)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94  + (Page 94)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 17  + (Paragraph 17)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22  + (Paragraph 22)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23  + (Paragraph 23)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approval  + (Paragraph 23 - Amendment approval)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report  + (Paragraph 23 - Final report)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Oversight  + (Paragraph 23 - Oversight)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28  + (Paragraph 25 – 28)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30  + (Paragraph 29 – 30)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32  + (Paragraph 31 – 32)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 36  + (Paragraph 36)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 9  + (Paragraph 9)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Part 1 Article 2  + (Part 1 Article 2)