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Good Clinical Practice (GCP) and Clinical Trials
Rating: 4.3 out of 5(7 ratings)
12 students
Created byAtlantis Learn
Last updated 7/2025
English

What you'll learn

  • Understand the structure and purpose of clinical trials
  • Apply the core principles of ICH-GCP (E6 R2)
  • Identify the roles of key stakeholders: sponsor, investigator, CRA, CRC, and IRB
  • Navigate ethical guidelines and major regulatory bodies (FDA, EMA, ICH)
  • Interpret protocol elements, informed consent, and clinical trial oversight procedures
  • Distinguish between clinical trial phases, study designs, endpoints, and blinding
  • Learn how AI, decentralized clinical trials, and patient-centric approaches are reshaping research

Course content

12 sections40 lectures2h 50m total length
  • What is Clinical Research?4:06
  • Phases of Clinical Trials4:08
  • Key Stakeholders in Clinical Research4:15
  • Overview of Regulatory Bodies (FDA, EMA, ICH, etc.)4:09

Requirements

  • No prior experience required. Just curiosity and commitment to learning about clinical trials.

Description

Course Description

Are you looking to break into clinical research or strengthen your knowledge of Good Clinical Practice (GCP)? This comprehensive course is your complete roadmap to understanding how modern clinical trials are conducted—ethically, efficiently, and in full regulatory compliance.

You’ll start with the foundations of clinical research, then dive into key historical milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report, which laid the groundwork for today’s ethical standards. From there, we’ll explore the ICH-GCP guidelines, the structure and roles in trial operations, and the lifecycle of a clinical study—from protocol to final report.

We’ll also look forward: you'll discover emerging innovations such as decentralized trials (DCTs), AI applications, and patient-centered trial designs, helping you stay ahead in a rapidly evolving field.

The course is structured into short, focused lectures—each with clear objectives and practical examples. Whether you're a student, healthcare professional, or aspiring CRC or CRA, this course will give you the solid foundation you need to succeed.

Who This Course Is For

  • Aspiring clinical research professionals (CRC, CRA, QA, Regulatory)

  • Healthcare workers transitioning into research

  • Medical, nursing, pharmacy, and life science students

  • Sponsors, monitors, site staff, and ethics committee members

  • Anyone preparing for GCP or ICH certification or onboarding into clinical trials

Requirements

  • No prior experience required

  • Just curiosity and commitment to learning about clinical trials

Who this course is for:

  • Clinical research professionals
  • Quality assurance professionals
  • Regulatory affairs professionals
  • Healthcare workers
  • Medical, nursing, pharmacy, and life science students
  • Anyone preparing for GCP or ICH certification
  • Anyone onboarding into clinical trials