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• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - Start  + (2.2.1. Anzeigeinhalte gegenüber den Bundesoberbehörden Anwendungsbeobachtungen sind nach § 67 Absatz 6 AMG gegenüber der zuständigen Bundesoberbehörd…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2  + (2.2.Ethical considerations Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical A…)
• Reference:ICH ICH E9 Guideline 1998 2.3  + (2.3 Design Techniques to Avoid Bias The most important design techniques for avoiding bias in clinical trials are blinding and randomisation, and thes…)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3  + (2.3 Investigational Product Management Various approaches to investigational product management (i.e., supply, storage, dispensing, administration, r…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3  + (2.3 Responsibilities 2.3.1 The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by t…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3  + (2.3. Methods for clinical performance studies 2.3.1. Clinical performance study design type Clinical performance studies shall be designed in suc…)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2  + (2.3.2 Certain documentation and processes already used in the institution/healthcare centre may be sufficient for the management of the investigationa…)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7  + (2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the da…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2  + (2.4 Communication with IRB/IEC [...] 2.4.2Before initiating a trial, the investigator/institution should have a documented and dated approval/favoura…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.4  + (2.4 Good clinical trials are designed to be feasible for their context […] Clinical trials should be tailored to be practicable given the available in…)
• Reference:ICH ICH E6 Guideline R3 (2025) II 2.4  + (2.4 In emergency situations, where consent cannot be obtained prior to trial participation, consent should be obtained from the participant or their l…)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.4 - 2.5  + (2.4 Investigator Oversight […] 2.5 Safety Assessment and Reporting For the safety monitoring of individual trial participants (see Annex 1, section 2.…)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4  + (2.4. Änderungsanzeigen nach § 67 Absatz 6 AMG Da sich die Anzeigepflicht nach § 67 Absatz 6 Satz 1 AMG auf das „Durchführen“ von Untersuchungen bezieh…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5  + (2.5 Compliance with Protocol 2.5.1The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the spons…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.5  + (2.5 Good clinical trials manage quality effectively and efficiently The design and conduct of a high-quality trial require competent decision-making …)
• Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002  + (2.5. Personnel Points to consider: […] • Relationship of the Investigator with the Sponsor company. […]…)
• Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001  + (2.5. Personnel Points to consider: • SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days. […] • Basic, imme…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001  + (2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002  + (2.7.1 Medical Care of Trial Participants (a) A qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professi…)
• 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…)