ICH GCP E6 R3 Good Clinical Practice v1

ICH GCP E6 R3 Annex 2 training

Supplementary Chapter: ICH GCP across the globe

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This course takes a practical, role-by-role approach to ICH E6(R3) Annex 2, covering the responsibilities of the IRB/IEC, the investigator, and the sponsor when trials go beyond the traditional site model. Core principles, Quality by Design (QbD), fitness-for-purpose, and risk-proportionate oversight, are applied throughout using interactive content, case studies, and knowledge checks. A 20-question final exam (80% pass mark) is required to obtain your downloadable training certificate.<h2 id="dd85ef7d-d98d-41a0-a457-806876ffa06f" data-toc-id="dd85ef7d-d98d-41a0-a457-806876ffa06f" style="font-size: 24px; line-height: 1.2;">KEY LEARNING OBJECTIVES</h2>Upon completion of this course, you will be able to:<ol><li>Define the key concepts of Annex 2: decentralized elements, pragmatic elements, RWD, DHTs, and usual clinical practice.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Apply the Quality by Design (QbD) and fitness-for-purpose framework to trial design decisions.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Explain the IRB/IEC's role in evaluating methodologies in decentralized and pragmatic trials.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Implement remote informed consent processes in compliance with Annex 2, including participant identity verification.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Apply risk-based investigator oversight across protocol-delegated tasks and usual clinical practice activities.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Manage investigational product supply, shipment, accountability, and blinding in decentralized settings.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Evaluate RWD sources for reliability (accuracy, completeness, traceability) and relevance to trial objectives.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Identify cybersecurity and data privacy risks in remote trial operations and implement appropriate safeguards.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Fulfil sponsor responsibilities for stakeholder engagement, RWD governance, and service provider oversight.</li><li class="font-claude-response-body whitespace-normal break-words pl-2">Synthesise safety data from multiple sources to support timely investigator decision-making.</li><li>Supplementary Chapter: ICH GCP across the globe</li></ol><h2 id="637850eb-e794-4e4c-a21a-63be7acbe643" data-toc-id="637850eb-e794-4e4c-a21a-63be7acbe643" style="font-size: 24px; line-height: 1.2;">WHO SHOULD ATTEND THIS TRAINING?</h2>This ICH GCP E6 R3 Annex 2 training is designed for clinical research professionals who need to understand and apply GCP in modern trial environments. It is particularly relevant for:<ul><li>Clinical Research Associates (CRAs) and Monitors from pharmaceutical companies and CROs overseeing trials with decentralised or pragmatic elements.</li><li>Sponsors and clinical operations teams&nbsp;running trials with RWD, DHTs, or home-based IP delivery.</li><li>Investigators and study coordinators conducting trials with remote visits, remote consent, or home-based activities.</li><li>Regulatory affairs and quality professionals preparing for audits and inspections under ICH E6(R3).</li><li>Clinical project managers, clinical leads, and clinical data managers overseeing complex, multi-modal trial designs.</li><li>IRB/IEC/Ethics Committee members who evaluate protocols incorporating novel methodologies, digital technologies, or pragmatic designs.</li><li>Any clinical research professional who has completed a GCP E6(R3) course and needs to incorporate Annex 2 training and certification to address the specific requirements of modern trial designs.</li></ul><h2 id="a7f24d2b-34ca-4f91-88d8-576c75016b1b" data-toc-id="a7f24d2b-34ca-4f91-88d8-576c75016b1b" style="font-size: 24px; line-height: 1.2;">METHODOLOGY</h2><ul><li>Content built directly from ICH E6(R3) Annex 2, with cross-references to the source guideline throughout</li><li>Interactive lessons, case studies, drag-and-drop exercises, and knowledge checks to reinforce learning</li><li>Role-based structure: IRB/IEC, Investigator, and Sponsor responsibilities covered in dedicated modules</li><li>20-question final exam; 80% pass mark required to obtain your training certificate</li><li>Self-paced and available 24/7,&nbsp; progress is automatically saved across devices</li></ul>

GCP compliance for modern trials. This online Annex 2 course covers decentralized elements, pragmatic designs, and real-world data, with a certificate. Built directly from the ICH E6(R3) guideline.

ICH GCP E6 R3 Annex 2 training

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