Fundamentals of Clinical Trials and Good Clinical Practice

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This course is designed for people who are new to clinical trials or come from non-clinical backgrounds. It will benefit those starting a Study Coordinator or Sub-Investigator role in a multi-centre trial, as well as staff at contract research organisations and sponsoring pharma companies who will be involved in clinical trials for the first time. It is also ideal for staff who need a grounding in the clinical trial process without the need to do the entire ICH GCP course. It focuses on the practical aspects of conducting phase II or III clinical trials at a site.This course covers the history of the ICH GCP Guidelines, ethical considerations, a review of the GCP Guidelines' key points, the drug development process and its phases, and clinical trial design concepts. Participants will gain important knowledge about how Good Clinical Practice (GCP) is applied in real-world settings.This course is designed to be international in scope. To learn more about specific guidelines for your location, please refer to the regulatory body that oversees drug and device development in your country.Successful completion will earn you a Certification.<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>Understand what GxP means in the pharma industry</li><li>Know what ICH GCP is and its content</li><li>Understand how and why the ICH GCP Guideline was developed</li><li>Understand how and why the ICH GCP Guideline was developed</li><li>Recognize how to access the ICH GCP E6 (R2) Guideline</li><li>Gain awareness of the principles of ICH GCP</li><li>List ICH GCP principles</li><li>Describe key roles involved in the clinical research process</li><li>Explain what a clinical trial protocol is and its components</li><li>Describe what an investigator’s brochure is</li><li>Identify the essential documents</li><li>Explain why clinical trials are performed</li><li>Distinguish the different phases in the drug discovery and development</li><li>List key elements to maintain scientific integrity</li><li>Understand the reasons to conduct clinical trials</li><li>Understand the rationale of the different types of study designs</li><li>List the most frequently used study designs</li><li>Understand what pharmacokinetics and pharmacodynamics are</li><li>Comprehend what study endpoints are and why they are necessary</li><li>Analyze the principles of ethical research</li></ol><h2 id="9843a9bc-06be-4435-8472-b4793b8a5a29" data-toc-id="9843a9bc-06be-4435-8472-b4793b8a5a29" 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</li><li>Persons starting a Study Coordinator or Sub-Investigator role in a multi-centre trial</li><li>Persons starting a career as staff at contract research organisations (CRO) and/or pharmaceutical companies who will be involved in clinical trials for the first time</li><li>Staff from University Hospitals, Research institutes, and research nurses</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></ul>

Fundamentals of Clinical Trials training is ideal for those embarking on a career in clinical research, as it provides essential knowledge and practical insights into clinical trials and Good Clinical Practice (GCP).

Fundamentals of clinical trials

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