Good Clinical Practice

ICH GCP E6 R3 Good Clinical Practice for Investigators and staff v2

Supplementary Chapter: ICH GCP across the globe

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The goal of this ICH GCP training is to train investigators and site personnel on all of the specific topics that TransCelerate BioPharma, Inc. has identified as necessary to enable mutual recognition of GCP training.This online ICH GCP course is ideal for clinical trial staff with ICH GCP experience who are taking the course as a GCP refresher. You will receive an official Good Clinical Practice certification that is widely recognized by all sponsors and CROs.You will learn how to apply good clinical practices in your daily work, at your own pace, with interactive content and real-life case studies. Successful completion (pass mark is 80%) of the exam will earn you a Good Clinical Practice Certification.<h2 id="6e4a8559-ee4d-4f92-83e9-886e7a8a8c11" data-toc-id="6e4a8559-ee4d-4f92-83e9-886e7a8a8c11" 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>Recognize the investigator's obligations&nbsp;</li><li>Recognize data governance requirements for the investigator and Sponsor</li><li>List the essential records required for the conduct of a clinical trial</li><li>Recognize the investigator's obligations&nbsp;in non-traditional clinical trials</li><li>ICH GCP E6 R3 Glossary</li><li>Key takeaways</li><li>Final Exam</li></ol><h2 id="0be4e35b-0d7b-4224-812f-1df467b13f63" data-toc-id="0be4e35b-0d7b-4224-812f-1df467b13f63" style="font-weight: 600; text-align: left; font-size: 24px; line-height: 1.2;">WHO SHOULD ATTEND THIS GCP TRAINING?</h2><ul><li>Physicians and staff working in health institutions (e.g., nurses, etc.) expecting to start a career in clinical research and requiring a documented Good Clinical Practice Certification.</li><li>Experienced physicians, investigators, and clinical research staff (e.g., nurses, study coordinators, etc.) requiring a documented Good Clinical Practice Certification.</li><li>Investigators from University Hospitals, Research institutes, and research nurses</li><li>Ehics committee members</li></ul><h2 id="110f1e1b-e6ac-4c5d-a890-c7c4aabfe007" data-toc-id="110f1e1b-e6ac-4c5d-a890-c7c4aabfe007" 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 the ICH-GCP E6 document to find the source material easily.</li><li>The final exam is a multiple-choice questionnaire.</li></ul>

This short ICH GCP E6 R3 online training for investigators offers a practical review of guidelines, helping you retain and apply knowledge. Ideal as a GCP refresher, it includes Annexes 1 and 2 and meets TransCelerate criteria.

ICH GCP E6 R3 Good Clinical Practice for Investigators and staff v2

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