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ClinicalTrials.gov.
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How to Complete the Regulatory Information Section
Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. For a definition of each field. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fields, refer to http://prsinfo.clinicaltrials.gov/definitions.html.
Instructions for recording regulatory information
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* |
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| 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 |
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