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• 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…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution  + (3.16 Data and Records 3.16.1 Data Handling [...] For systems used or deployed by the investigator/institution: [...] (vii) In situations where clinica…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 (g)  + (3.16.1 Data Handling [...] (g) Procedures should be in place to describe unblinding; where applicable; these descriptions should include: (i) who …)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.19  + (3.19 device deficiency […]…)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction  + (3.2 Ethics committee The role of the ethics committee (or other board responsible for reviewing the trial) is to ensure the protection of the rights a…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility  + (3.2 Ethics committee [...] The ethics committee has an ongoing responsibility for the ethical conduct of research, and therefore must be informed of a…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Consultation  + (3.2 Ethics committee [...] The investigator, or the investigator and the sponsor, must consult the relevant ethics committee(s) regarding the suitabil…)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2  + (3.2. When should the notification be made? Without undue delay and at the latest within 7 calendar days of the sponsor becoming aware of a serious bre…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 3.2.4  + (3.2.4 Training and mentoring Investment in education and training is required in all regions through accessible (practically and financially) fit-for-…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c)  + (3.3 Informed consent […] c) The subject must have access to information about insurance, if any, and other procedures for compensation and treatment s…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g)  + (3.3 Informed consent […] c) The subject must have access to information about insurance, if any, and other procedures for compensation and treatment s…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g)  + (3.3 Informed consent […] e) Careful consideration should be given to ensuring the freedom of consent obtained from members of a group with a hierarchi…)
• Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5  + (3.3.5 Critical to Quality Factors in Operational Practice The foundation of a successful study is a protocol that is both scientifically sound and ope…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.33  + (3.33 malfunction […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45  + (3.45 serious adverse event SAE […]…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.5  + (3.5 Financing The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.…)
• 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 3.5.2  + (3.5.2. Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may…)
• 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 3.5.3  + (3.5.3. Correspondence Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. T…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.6  + (3.6 Agreements 3.6.1 Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9  + (3.9 Sponsor Oversight [...] 3.9.7 The sponsor may consider establishing an IDMC to assess the progress of a clinical trial, including the safety data …)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3  + (3.9.3 The sponsor should determine necessary trial-specific criteria for classifying protocol deviations as important. Important protocol deviations a…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 31 – 32  + (31. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 36  + (36. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the resul…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4  + (4. A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the clinical inv…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7  + (4. For the purpose of this Article, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of th…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 4 – 5  + (4. If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted o…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5  + (4. If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation w…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4  + (4. In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 78, the sponsor shall report…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4  + (4. In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any …)