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submittrialregulatory
submittrialregulatory
Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.

Info

The system will not display this section if you indicated that you do not require an XML document for ClinicalTrials.gov.

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hiddentrue

Screenshot TBD.

 

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

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