GCP: The IND, How to Gain Approval for Clinical Trials in the USA

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Program/Course ID: GCP07 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.

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Outline: Regulatory overview: This session briefly describes the legislative guidelines that apply to obtaining FDA approval to conduct clinical trials in the USA. An introduction to Investigational New Drug Applications: This session provides a brief overview of the IND and of the submission process. IND content and format requirements: Explore the specific format and content requirements of an IND application as specified by the Center for Drug Evaluation and Research (CDER). The IND review and approval process: This session discusses the FDA review principles for IND applications, with a view to improving your application. Maintenance of an IND: This session outlines the different types of IND amendments, when they are required, and the regulations that govern them. Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or a consolidation of learning points.		Objectives: Students completing this course should be able to: Describe what an IND is, and why it is needed. Access the key regulatory documents surrounding INDs. Describe the content and format of an IND application. Describe the IND review and approval process. Describe the IND reporting requirements, and the types of amendments that can be made to an IND.

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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	GCP: The IND, How to Gain Approval for Clinical Trials in the USA