ICH GCP E6 R3 Good Clinical Practice v1

Supplementary Chapter: ICH GCP across the globe

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The 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 6 CPD points.<h2 id="dd85ef7d-d98d-41a0-a457-806876ffa06f" data-toc-id="dd85ef7d-d98d-41a0-a457-806876ffa06f" style="font-size: 24px; font-weight: 600; 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 roles and responsibilities of the key players in a clinical trial: the ethics committees, the investigators, sponsors, monitors, and support staff.</li><li>Comply with documentation and reporting obligations, learn how to avoid GCP non-compliance, and how to conduct a quality trial.</li><li>Understand the principles of data capture and the importance of data quality;</li><li>Understand the informed consent process and its key aspects.</li><li>Understand the structure and content of the clinical trial protocol, its amendments, and the investigator’s brochure;</li><li>Understand the purpose and types of the essential documents required for the conduct of a clinical trial;</li><li>Supplementary Chapter: US FDA GCP specifics</li></ol><h2 id="637850eb-e794-4e4c-a21a-63be7acbe643" data-toc-id="637850eb-e794-4e4c-a21a-63be7acbe643" style="font-size: 24px; font-weight: 600; 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-size: 24px; font-weight: 600; 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 keeps professionals current, covering stakeholder responsibilities with practical scenarios, quizzes, and assessments. Learners gain feedback and earn recognized certification via the platform.


ICH GCP E6 R3 Good Clinical Practice v1

PharmaEduCenter Training

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