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Clinical Research

Fundamentals of clinical trials and Good Clinical Practice (Fund-EN)


Description
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Hey! Welcome to PharmaEduCenter! We're thrilled to have you on our team! Take your time to complete this course at your own pace.
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 organizations 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.
Content
  • Fundamentasl of Clinical trials and Good Clinical Pra
  • Fundamentals of clinical trials and Good Clinical Practice
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Completion rules
  • You must complete the units "Fundamentals of clinical trials and Good Clinical Practice"
  • Leads to a certificate with a duration: 3 years