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Field Label | Description/Instructions | |||||||
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Studies a U.S. FDA-regulated Drug Product* |
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Studies a U.S. FDA-regulated Device Product* |
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Unapproved/Uncleared Device* | 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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Product Exported from the U.S. |
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FDA Regulated Intervention Indicator* |
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Section 801 Indicator* |
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Data Monitoring Committee Appointed Indicator Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No. Info | |
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