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U.S. Food and Drug Administration
Protecting and Promoting Your Health

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Center for Drug Evaluation and Research

FDA eCTD Overview and Submission WBT

Validating eCTD Submissions

Check Your Understanding

Which validation checks are needed to ensure compliance with eCTD specifications? Select all that apply. Click here if you would like to review the pertinent content before answering the question.

	A.	Ensuring that the application form submitted matches the application type specified in the us-regional.xml file
	B.	Ensuring the consistency of the application number specified in the us-regional.xml file and application form
	C.	Ensuring that the CD-ROM containing additional datasets includes files in an incompatible file format
	D.	Ensuring that the index.xml file, a necessary component of the eCTD, is missing

USER INSTRUCTIONS:

Select all of the correct answers and then click the Check Answer button.

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