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• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Organisation  + (Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a…)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation  + (Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a…)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD  + (Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a…)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Monitoring  + (Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a…)
• Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance  + (Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" a…)
• Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -  + (FDA requires that an Institutional Review Board (IRB) review and have authority to approve, requiremodifications in, or disapprove all research activi…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 25 – 28  + (Free and Informed Consent 25. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals ca…)
• Reference:GBR MHRA GCP Inspection Dossier template V7.0 -  + (GCP Inspection Dossier template […] 13. Artificial Intelligence and Machine Learning Please explain where artificial intelligence and/or machine learn…)
• Reference:WMA Declaration of Helsinki 2024 -  + (GENERAL PRINCIPLES [...] 7. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, de…)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 9  + (GENERAL PRINCIPLES [...] 9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonom…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 15  + (General principles A substantial modification, including the addition of a clinical trial site or the change of a principal investigator in the clini…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1  + (General requirements regarding clinical investigations conducted to demonstrate conformity of devices 1. Clinical investigations shall be designed,…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j)  + (General requirements regarding clinical investigations conducted to demonstrate conformity of devices (j) the medical care provided to the subjects i…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 57  + (General requirements regarding performance studies 1. The manufacturer shall ensure that a device for performance study complies with the general s…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1 (f)  + (General rules (f) the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate,…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1  + (General rules 1. A clinical trial may be conducted only where all of the following conditions are met: (a) the anticipated benefits to the subject…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)  + (Good Clinical Practice (GCP) A standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reportin…)
• Reference:ICH ICH E6 Guideline R3 (2025) I  + (Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. …)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20  + (Guideline 2: Ethical review committees [...] Commentary on Guideline 2 [...] Failure to submit a protocol to the committee should be considered a clea…)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23  + (Guideline 4: Individual informed consent [...] Commentary on Guideline 4 [...] Renewing consent. When material changes occur in the conditions or the…)
• Reference:INT ISPE - GPP Revision 3 (2015) -  + (Guidelines for Good Pharmacoepidemiology Practices (GPP) International Society for Pharmacoepidemiology (ISPE) https://www.pharmacoepi.org/resources/…)
• Reference:GBR HRA - Ending your project 28-Jan-2025 -  + (HRA (England) website: https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/ending-your-project/ Final report on the research Once you …)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  + (I.6.3 Non-interventional clinical investigation […]…)
• Reference:ICH ICH E8 Guideline R1 (2021) -  + (ICH guideline E8 (R1) on general considerations for clinical studies…)
• Reference:ICH ICH E6 Guideline R3 (2025) II  + (II. PRINCIPLES OF ICH GCP [...] 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declara…)

• Reference:INT ISPE - GPP Revision 3 (2015) II.  + (II. Protocol Development [...]…)

• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Introduction  + (II. SUMMARY OF THE CONSENT PROCESS To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the c…)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-001  + (II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing conse…)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. Advertising-002  + (II. SUMMARY OF THE CONSENT PROCESS […] FDA considers advertising used to recruit subjects into the clinical trial to be the start of the ongoing conse…)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. B.  + (III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES [...] B. Protecting the Rights, Safety, and Welfare of Study Subjects Investigators are re…)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A.  + (III. CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES This section of the guidance clarifies the investigator’s responsibility to supervise the…)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 2.  + (III. Electronic Source Data [...] 2. Source Data Capture Data can be entered into the eCRF either manually or electronically as described below. a. Di…)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 III 4.  + (III. Electronic Source Data […] 4. Modifications and Corrections Only a clinical investigator(s) or delegated clinical study staff should perform modi…)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III.  + (III. FDA INFORMED CONSENT REQUIREMENTS AND DISCUSSION […] E. Documentation of Informed Consent [...] b. Short Form An IRB may approve a short form to …)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015 III  + (III. GENERAL PRINCIPLES [...] C. Source documents should be retained to enable a reconstruction and evaluation of the trial. D. When original observat…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III - IV.  + (III. OVERVIEW OF MONITORING METHODS A. On-Site and Centralized Monitoring 1. On-Site Monitoring 2. Centralized Monitoring B. Examples of Alternative M…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.  + (III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor sho…)
• Reference:ICH ICH E9 Guideline 1998 III  + (III. TRIAL DESIGN CONSIDERATIONS 3.1 Design Configuration 3.1.1 Parallel Group Design […] 3.1.2 Crossover Design […] 3.1.3 Factorial Designs […] 3.2 M…)
• Reference:IMDRF IMDRF – Guidelines - -  + (IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF) GHTF Study Group 4 – Auditing https://www.imdrf.org/doc…)
• Reference:USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007 IV  + (IV. RECOMMENDATIONS [...] C. Source Documentation and Retention When original observations are entered directly into a computerized system, the electr…)
• Reference:USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.  + (IV. RESPONSIBILITIES FOR INFORMED CONSENT […] B. The Clinical Investigator The clinical investigator is responsible for protecting the rights, safety,…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Verification  + (IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Verification that informed consent was obtained appropriat…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Adherence  + (IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Adherence to protocol eligibility criteria designed to exc…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A. Conduct  + (IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] • Conduct and documentation of procedures essential to trial…)
• Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 IV A.  + (IV. RISK-BASED MONITORING […] A. Identify Critical Data and Processes to be Monitored […] Other types of data (e.g., covariates such as concomitant tr…)
• Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC  + (Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-m…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Independent Data Monitoring Committee (IDMC)  + (Independent Data Monitoring Committee (IDMC) An independent data monitoring committee (e.g., data safety monitoring board) that may be established by …)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC  + (Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 73 Paragraph 1, 3, 4  + (Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination 1. If the sponsor has tempo…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1, 3 & 4  + (Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has …)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 1 – 3  + (Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination 1. If the sponsor has …)