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• 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 Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may…)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 …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 17 Paragraph 4-5  + (4. Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application d…)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4  + (4. Clarification on reporting requirements • Serious breaches which occurred outside the EU/EEA while the application for a clinical trial authorisati…)

• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4  + (4. DATA GOVERNANCE – INVESTIGATOR AND SPONSOR…)

• Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.  + (4. Informed consent of trial subjects […] Documentation in the source data of the process of obtaining the initial informed consent and subsequent con…)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4  + (4. „sonstige klinische Prüfung“ eines Produktes eine klinische Prüfung, die a) nicht Teil eines systematischen und geplanten Prozesses zur Produktent…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1  + (4.1 Medical care of trial subjects The investigator is responsible for adequate and safe medical care (or dental care, where appropriate) of subjects …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.10  + (4.10 Serious adverse events/reactions The investigator must take appropriate measures to ensure the safety of clinical trial subjects (see also Sectio…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.11  + (4.11 Financing The relationship between the investigator and the sponsor in matters such as financial support, fees, honorarium payments in kind must …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-001  + (4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002  + (4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003  + (4.12 Monitoring, auditing and inspection The investigator must be prepared to receive and be available for periodic visits by the monitor(s) and accep…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.15  + (4.15 Termination of trial In the case of premature termination of the clinical trial, the investigator must inform the drug regulatory authority, the …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.16  + (4.16 Final report After completion of the trial, a final report must be drawn up and submitted to the drug regulatory authority. The report should be …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.17  + (4.17 Trials in which the investigator is the sponsor In clinical trials in which the investigator is the sponsor, he or she is responsible for the cor…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.1  + (4.1Safeguard Blinding in Data Governance 4.1.1 Maintaining the integrity of the blinding is important in particular in the design of systems, manageme…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.1  + (4.2 Data Life Cycle Elements Procedures should be in place to cover the full data life cycle. 4.2.1 Data Capture (a) When data captured on paper or…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.2  + (4.2 Qualifications The investigator should: · have qualifications and competence in accordance with local laws and regulations as evidenced by an up-t…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2  + (4.2. Responsibilities Roles and responsibilities in clinical trials should be clearly defined. The responsibility for the conduct of clinical trials …)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4  + (4.2.3 Review of Data and Metadata Procedures for review of trial-specific data, audit trails and other relevant metadata should be in place. It should…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3  + (4.3 Computerised Systems As described in sections 2 and 3, the responsibilities of the sponsor, investigator and the activities of other parties with…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3  + (4.3 Expedited AE (i.e., SAE) Reporting Timelines Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizin…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.3  + (4.3 Selection of trial subjects The investigator is responsible for ensuring the unbiased selection and an adequate number of suitable subjects accord…)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3  + (4.3. Inspection cooperation • Cooperation between the EU/EEA MSs: Nearly all the inspections conducted in 2022 were joint inspections involving inspe…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3  + (4.3.3 Security (a) The security of the trial data and records should be managed throughout the data life cycle. (b) The responsible party should ens…)
• Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1  + (4.3.3.1 Investigations in pregnant women Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrol…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4  + (4.3.4 Validation (a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validatio…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8  + (4.3.8 User Management (a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction  + (4.4 Compliance with the protocol The investigator must agree and sign the protocol ( or another legally acceptable document mentioning the agreement w…)