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• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a) - (d)  + (2.7.2 Safety Reporting (a) Adverse events and/or abnormal test results required for safety evaluations (as outlined in the protocol) should be report…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.2 (a)  + (2.7.2 Safety Reporting (a) [...] Unfavourable medical events occurring in participants before investigational product administration (e.g., during sc…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3  + (2.7.3. Qualitätssicherung Die für epidemiologische Studien üblichen Qualitätsanforderungen gelten auch für Anwendungsbeobachtungen. Ziel der Qualität…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4  + (2.7.4. Patientenaufklärung und -einwilligung In der Regel müssen Patienten vor dem Einschluss in eine Anwendungsbeobachtung über die Anwendungsbeobac…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6  + (2.7.6. Berichte und Archivierung Ergebnisse von Anwendungsbeobachtungen sollten nach wissenschaftlichen Kriterien publiziert werden. Es wird empfohle…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7  + (2.7.7. Vergütung und Honorierung Die Beteiligung an einer Anwendungsbeobachtung ist in der Regel eine ärztliche Tätigkeit. Bei Arzneimitteln, die nic…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8  + (2.8 Informed Consent of Trial Participants…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12  + (2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13  + (2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participant’s legally acceptable repr…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8  + (2.8.8 In emergency situations, when prior consent of the participant is not possible, the consent of the participant’s legally acceptable representati…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9  + (2.8.9 If a participant or the legally acceptable representative is unable to read, an impartial witness should be present (remotely or in-person) duri…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.3  + (2.9 End of Participation in a Clinical Trial [...] 2.9.3 Where relevant, the investigator should inform the participant about the trial results and tr…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1  + (2.9 End of Participation in a Clinical Trial 2.9.1 When a participant decides to stop treatment with the investigational product or withdraw from a tr…)
• Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9  + (2.9. Recruitment and consent Points to consider: • Recruitment strategies. • Volunteer database. • Collection and verification of the trial participan…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23 - Final report  + (23. [...] After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusi…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 29 – 30  + (29. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 29A  + (29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of - (a) the conditions and principles …)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3  + (3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4  + (3. Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participati…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 87 Paragraph 3 – 5  + (3. Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1 immediately after they have established the causal rel…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5  + (3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5  + (3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5  + (3. The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3  + (3. The sponsor shall also report to the Member States in which the clinical investigation is being conducted any event referred to in paragraph 2 of…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6  + (3. Where, regarding the substantial modification of aspects covered by Part I of the assessment report, the substantial modification is acceptable o…)

• Reference:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023) 3  + (3. Development of the study protocol [...]…)

• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1  + (3. How to report a serious breach 3.1. Who should notify The sponsor is responsible for the notification via the EU portal and EU database - part of …)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2  + (3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.2. Nationale Anzeigepflicht nach § 63…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1  + (3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.1. Definition einer Unbedenklichkeitss…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3  + (3. Nichtinterventionelle Unbedenklichkeitsstudien nach der Zulassung (Postauthorisation safety studies: PASS) 3.3. Anzeigeninhalte gegenüber den Bund…)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3.  + (3. RAPPORT ANNUEL DE SECURITE Bien que le RDM ne le prévoie pas, il est demandé pour les RIPH1 portant sur un DM se poursuivant après le 26 mai 2021 …)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1  + (3. SPONSOR [...] 3.17.1Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly i…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8  + (3. SPONSOR [...] 3.8 Communication with IRB/IEC and Regulatory Authority(ies) 3.8.1 Notification/Submission to Regulatory Authority(ies) In accordanc…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 3.17.2  + (3. SPONSOR […] 3.17.2 Clinical Trial/Study Reports (a) Whether the trial is completed or prematurely terminated, or an interim analysis is undertaken …)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3  + (3. SPONSOR…)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3  + (3. Sponsor 3.1 Engagement and Communication […] 3.1.1 Engaging patients, patient advocacy groups and their communities, as appropriate, can help ensur…)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3  + (3. Trial master file structure and contents 3.1. Sponsor and investigator trial master file The TMF is usually composed of a sponsor TMF, held by the …)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a)  + (3.1.2. Categorisation of findings a) General overview A total of 470 deficiencies, comprising 17 critical (3.6%), 260 major (55.3%) and 193 minor (41.…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6  + (3.10.1.6 Risk Reporting The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded,…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.3 - 3.11.4.6  + (3.11 Quality Assurance and Quality Control [...] 3.11.4 Monitoring The aim of monitoring is to ensure the participants’ rights, safety and well-being …)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2  + (3.11 Quality Assurance and Quality Control [...] 3.11.2 Audit When performed, audits should be conducted in a manner that is proportionate to the risk…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4 3.11.4.1 - 3.11.4.2  + (3.11.4 Monitoring [...] Monitoring activities may include site monitoring (performed on-site or remotely) and centralised monitoring, depending on the…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.2  + (3.11.4.5.2 Investigator Site Selection, Initiation, Management and Close-out [...] (j) Confirming the arrangement for the retention of the essential r…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3  + (3.11.4.5.3 Monitoring of Investigational Product Management (a) Confirming, for the investigational product(s): (i) That storage conditions are acc…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12  + (3.12 Noncompliance 3.12.1 Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirement(s) by an investigator/institution or by…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1  + (3.13.1 Sponsor Review of Safety Information The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. T…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (a) - (b) ; (d) - (f)  + (3.13.2 Safety Reporting (a) The sponsor should submit to the regulatory authority(ies) safety updates and periodic reports, including changes to the I…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.2 (c)  + (3.13.2 Safety Reporting [...] (c) Safety reporting to regulatory authorities should be undertaken by assessing the expectedness of the reaction in rel…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001  + (3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the spo…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-002  + (3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the spo…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15  + (3.15 Investigational Product(s) [...] (d) In blinded trials, the sponsor should implement: (i) A process to blind individuals, including the sponso…)