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Comment: For CTRPMICRO-11, revised based on clarification from Michael Izbicki.

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Field Label

Description/Instructions

Studies a U.S. FDA-regulated Drug Product*

Include Page

	Regulatory Drug field - Include 20170414
	Regulatory Drug field - Include 20170414

Studies a U.S. FDA-regulated Device Product*

Include Page

	Regulatory Device field - Include 20170414
	Regulatory Device field - Include 20170414

Unapproved/Uncleared Device*

Include Page

	Regulatory Unapproved Uncleared field - Include 20170414
	Regulatory Unapproved Uncleared field - Include 20170414

This field is read-only. You may request a change in its value by submitting a request to the CTRO at ncictro@mail.nih.gov.

Post Prior to U.S. FDA Approval or Clearance

Include Page

	Regulatory Post Prior field - Include 20170414
	Regulatory Post Prior field - Include 20170414

Pediatric Post-market Surveillance

Include Page

	Regulatory Pediatric field - Include 20170414
	Regulatory Pediatric field - Include 20170414

Product Exported from the U.S.

Include Page

	Regulatory Exported field - Include 20170414
	Regulatory Exported field - Include 20170414

FDA Regulated Intervention Indicator*

Indicate whether the trial is regulated by the FDA by selecting Yes or No.

Note
You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE. If the trial is interventional and you indicated that it is regulated by the FDA, the Regulatory Information section displays fields for Section 801. You are required to complete these fields.

Section 801 Indicator*

Include Page

	Regulatory Section 801 field - Include 20170414
	Regulatory Section 801 field - Include 20170414

Note
If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes available and defaults to No. This field is read-only. You may request a change in its value by submitting a request to the CTRO at ncictro@mail.nih.gov.

Data Monitoring Committee Appointed Indicator

Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.

Info
This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory affairs office.