Brief Introduction to ICH E6 (R3) guidelines
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The ICH E6 (R3) guidelines provide comprehensive instructions for conducting clinical trials while prioritizing patient rights, safety, and ethical considerations. Key updates include a focus on risk assessment, quality management, and proper informed consent processes, along with enhanced data governance procedures. The guidelines aim to harmonize clinical trial practices globally and ensure compliance with regulatory requirements.
Brief Introduction to ICH E6 (R3) guidelines
- 1. ICH E6 (R3) guidelines Rutuja Arlekar
- 2. CONTENTS 01 Introduction to ICH E6 (R3) 05 Implementation and Compliance 02 Key Updates in ICH E6 (R3) 06 Data Governance 03 Roles and Responsibilities 04 Informed Consent Process
- 3. PART ONE Introduction to ICH E6 (R3)
- 4. 01 Provides detailed instructions for conducting clinical trials in compliance with regulatory standards. Comprehensive Guidance 02 Emphasizes the importance of patient rights, safety and well-being throughout the clinical trial process. Strengthened Patient Protections Overview of the Guidelines
- 5. 03 Aims to align clinical trial practices across different regions and regulatory authorities. Harmonized Global Standards 04 Aims to proactively designing quality into clinical trials. Fostering a quality culture Overview of the Guidelines
- 6. PRINCIPLES OF ICH GCP 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and applicable regulatory requirement(s). Clinical trials should be designed and conducted in ways that ensure the rights, safety and well-being of participants. 2. Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed. 3. Clinical trials should be subject to an independent review by an IRB/IEC. 4. Clinical trials should be scientifically sound for their intended purpose and based on adequate and current scientific knowledge and approaches. 5. Quality should be built into the scientific and operational design and conduct of clinical trials.
- 7. 6. Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected and that avoids unnecessary burden on participants and investigators. 7. Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected and that avoids unnecessary burden on participants and investigators. 8. Clinical trials should be described in a clear, concise, scientifically sound and operationally feasible protocol. 9. Clinical trials should generate reliable results. 10.Roles and responsibilities in clinical trials should be clear and documented appropriately. 11.Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be managed in accordance with the product specifications and the trial protocol.
- 8. PART TWO Key Updates in ICH E6 (R3)
- 9. Design and implementation of efficient clinical trial protocols, including tools and procedures for trial conduct. Emphasizes risk assessment Focuses on identifying, evaluating, and mitigating risks to data integrity and patient safety. Quality Management Performing audits and monitoring Clinical Trials. Quality Assurance and Quality Control Quality By Design (QbD)
- 10. Risk Assessment
- 12. PART THREE Roles and Responsibilities
- 13. • Collaborate with investigators to create a robust study protocol. • Ensure proper monitoring and auditing of clinical trials. • Obtains and documents informed consent from each participant. • Ensures proper conduct of the clinical trial and protection of participants. • Ensures proper storage, handling, and administration of the investigational product. • Review and approve study protocols, informed consent, and other study- related documents. • Monitor ongoing studies for compliance with ethical standards
- 14. PART FOUR Informed Consent Process
- 15. Requirements 1. Comply with regulatory requirements and Good Clinical Practice (GCP). 2. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved. 3. Clear, concise language and varied approaches (text, images, videos). 4. Ensuring participants understand trial objectives, risks, benefits, and any alternatives available .
- 16. Elements of Informed Consent Clearly explain the purpose and objectives of the research. Purpose of study Disclose potential risks and anticipated benefits of participation. Risks and benefits Outline the expected commitments and activities for participants. Participant responsibilities
- 18. â—Ź Continuous Evaluation â—Ź Assess participant's ongoing willingness to continue in the study. â—Ź Voluntary Withdrawal â—Ź Ensure participants can withdraw consent at any time without penalty. â—Ź Revised Information â—Ź Provide updated study information to participants as it becomes available. Ongoing Consent
- 20. Accuracy, completeness, and consistency of trial data. Data Integrity Protect trial data from unauthorized access, alteration, or loss Data Security Implement procedures for data capture, verification, validation, and review. Data Management Data Governance
- 21. Computerized Systems 1. Validation: Ensure computerized systems are fit for purpose, validated, and maintained. 2. Security: Implement security controls, including user management, access controls, and backup procedures. 3. Training: Provide training for users of computerized systems. 4. Technical Support: Establish mechanisms for documenting, evaluating, and managing system issues.
- 22. Data Life Cycle
- 24. Expanded requirements for risk-based approaches and quality management. Key Updates Emphasis on electronic data capture and management. Increased Focus on Data Integrity Reduced redundant documentation requirements. Streamlined Documentation Transition from ICH E6 (R2)
- 25. â—Ź Alignment with Regulations â—Ź Ensuring ICH E6 (R3) guidelines are fully integrated into organizational processes. â—Ź Demonstrating Compliance â—Ź Implementing robust quality management systems to meet regulatory requirements. â—Ź Regulatory Oversight â—Ź Preparing for inspections and audits to validate adherence to guidelines. Regulatory Acceptance
- 26. Thank You