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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.

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
Include Page
Regulatory Intervention field - Include 20170414
Regulatory Intervention field - Include 20170414

Section 801 Indicator*

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

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.