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Good Clinical PracticeICH E6(R3) from the ground up, with a free verifiable completion record.2 courses · ~25h · Optional paid certificate

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The IND and Clinical Development — Clinical Research Foundations

Good Clinical Practice (GCP)Course 1 of 2

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Clinical Research Foundations
The IND and Clinical Development

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Good Clinical Practice (GCP)

Full course · Clinical Research Foundations

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Good Clinical Practice (GCP)1 of 2

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This lesson is part of a complete GCP track — 2 courses, quizzes, a final exam, and a free verifiable credential. The optional $29 PDF certificate is recognized by 18+ trial sponsors.

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The IND and Clinical Development

Understand the regulatory gateway from laboratory research to human clinical trials.

20 min

What you will learn6 objectives

By the end of this lesson, you will be able to:

Define what an Investigational New Drug (IND) application is and explain its purpose
Identify the three main components of an IND submission
Describe the FDA's 30-day review process and possible outcomes
Explain what a clinical hold is and when the FDA can impose one
Recognize situations where an IND may not be required
Compare the IND process in the United States with the Clinical Trial Application (CTA) process in Europe

The IND application compiles preclinical evidence to justify the transition to human trials. — FigureThe IND application compiles preclinical evidence to justify the transition to human trials.

Progress saves itself — finish reading and this lesson completes