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Field Label

Description/Instructions

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

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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 readonly - Include 20170508
Regulatory Unapproved Uncleared field readonly - Include 20170508

This field is read-only. The default value is No, which indicates the release of trial information on Cancer.gov is not being delayed until after an interventional device has been approved or cleared. You may request a change in the value for this field by submitting a request to the CTRO at ncictro@mail.nih.gov.

Pediatric Post-market Surveillance

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

Product Exported from the U.S.

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

FDA Regulated Intervention Indicator*

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

Section 801 Indicator*

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

Data Monitoring Committee Appointed Indicator

Include Page
Regulatory DMC Appointed field - Include 20170418
Regulatory DMC Appointed field - Include 20170418