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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* |
| Post Prior to U.S. FDA Approval or Clearance | |||||||||||
Include Page | Regulatory Post Prior field - Include 20170414 | Regulatory Post Prior field - Include 20170414
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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* | Indicate whether the trial is regulated by the FDA by selecting Yes or No.
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Section 801 Indicator |
| Section 801 Indicator* | For interventional trials, indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No. Note | | |||||||||
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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