ICH GCP E6 R3 Good Clinical Practice v2

Supplementary Chapter: ICH GCP across the globe

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minimum criteriaThe objective of this ICH GCP Good Clinical Practice training is to train clinical research professionals and anyone involved in clinical research, providing individuals with an official Good Clinical Practice certification that is widely accepted by all sponsors and CROs.This ICH GCP training course covers all sections specified by the ICH GCP E6 R3 guideline and meets the training requirement for you to participate in international clinical trials. This ICH GCP training provides you with a practical review of good clinical practice guidelines, allowing you to retain and apply the informationYou will learn how to apply good clinical practices in your daily work at your own pace, using interactive content and real-world case studies. You will obtain an ICH GCP certification after passing the test with a score of 80%.This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of ICH GCP training among trial sponsors. Additionally, it is accredited by the Faculty of Pharmaceutical Medicine (UK) and offers participants the opportunity to earn 8 CPD points.<h2 id="dd85ef7d-d98d-41a0-a457-806876ffa06f" data-toc-id="dd85ef7d-d98d-41a0-a457-806876ffa06f" style="font-weight: 600; text-align: left; font-size: 24px; line-height: 1.2;">KEY LEARNING OBJECTIVES</h2>Upon completion of this course, you will be able to:<ol><li>Summarize the purpose of the ICH GCP guidelines</li><li>List ICH GCP Principles</li><li>Comprehend the role of the IRB/IECs, Investigators, Sponsors/monitor and appropriate data governance.</li><li>Understand what an Investigator Brochure is</li><li>List essential records required for the conduct of a clinical trial</li><li>Explain the purpose and scope of Annex 2 and its integration with Annex 1 and the core principles of GCP.</li><li>Implement Quality by Design (QbD) and proportionality principles to customize quality assurance measures based on trial design, risks, and critical-to-quality factors.</li><li>Adapt informed consent processes and investigational product (IP) management to suit remote, hybrid, and pragmatic trial settings while ensuring accountability and safety.</li><li>Evaluate investigator responsibilities in delegating tasks and overseeing data collection, ensuring reliability across both "usual clinical practice" (e.g., EHR) and DHTs acting as data acquisition tools.</li><li>Assess sponsor responsibilities in protocol design, vendor/service provider management, and the ethical use of diverse data sources, including RWD.</li><li>Identify and mitigate data-related risks, including variability, missing data, cybersecurity vulnerabilities, and confidentiality breaches, using a risk-based approach.</li><li>Develop the critical thinking skills necessary to interpret Annex 2 guidance and apply it proportionately to evolving trial technologies through interactive case studies and simulations</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-weight: 600; text-align: left; font-size: 24px; line-height: 1.2;">WHO SHOULD ATTEND THIS GCP TRAINING?</h2><ul><li>Persons expecting to start a career in clinical research within Pharmaceutical Companies or CROs, as CRAs / Monitors, Clinical Leads, Project Managers, etc.</li><li>Experienced clinical research staff (personnel from sponsors, pharmaceutical companies, and CROs, as CRAs / Monitors, clinical leads, project managers, sponsors, clinical trial assistants, etc.) requiring a documented Good Clinical Practice certification.</li><li>New or experienced physicians, investigators, study coordinators, and clinical research staff requiring a documented Good Clinical Practice certification.</li><li>Staff from University Hospitals, Research institutes, and research nurses</li><li>Ethics committee members</li></ul><h2 id="a7f24d2b-34ca-4f91-88d8-576c75016b1b" data-toc-id="a7f24d2b-34ca-4f91-88d8-576c75016b1b" style="font-weight: 600; text-align: left; font-size: 24px; line-height: 1.2;">METHODOLOGY</h2><ul><li>it is Interactive with an attractive format</li><li>You will be able to solve problems through the course to reinforce your learning.</li><li>We cross-reference to the ICH-GCP E6 document to easily find the source material.</li><li>The final exam is a multiple-choice questionnaire.</li></ul>

ICH E6(R3) GCP online training covering Annex 1 and Annex 2. This course meets TransCelerate Biopharma criteria and is also accredited by the Faculty of Pharmaceutical Medicine (UK), offering participants the opportunity to earn 8 CPD points


ICH GCP E6 R3 Good Clinical Practice v2

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