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Comment: For CTRPMICRO-11, revised based on review feedback 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 readonly - Include 20170508
Regulatory Unapproved Uncleared field readonly - Include 20170508

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*

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

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