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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.
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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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Screenshot TBD.

 Regulatory Information section of the Register Trial pageImage Removed

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. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fieldsFor a definition of each field, refer to http://prsinfo.clinicaltrials.gov/definitions.html.

Instructions for recording regulatory information

This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory affairs office.

Field Label

Description/Instructions

Trial Oversight Authority Country*

Select the name of the country in which the oversight authority organization is located.
After you make your selection, the oversight authorities registered in the country you selected are listed in the Trial Oversight Authority Organization Name field.

Trial Oversight Authority Organization Name*

Select the name of the organization that oversees the trial from the drop-down list.

FDA Regulated Intervention Indicator*

Indicate whether the trial is regulated by the FDA by selecting Yes or No.

Note

You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE.
If the trial is interventional and you indicated that it is regulated by the FDA, the Regulatory Information section displays fields for Section 801. You are required to complete these fields.

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

If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes available and defaults to No. This field is read-only. You may request a change in its value by submitting a request to the CTRO at ncictro@mail.nih.gov.

Delayed Posting Indicator*

This indicator becomes available only when you indicate that the trial is applicable under Section 801. Only the CTRO can modify this indicator’s value:

  • A No value indicates that any devices in the trial have already been approved or cleared by the US FDA, and so there is no need to delay posting of trial information information on ClinicalTrials.gov.
  • A Yes value indicates that the release of trial information on ClinicalTrials.gov is being delayed until after an interventional device has been approved or cleared.

To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov.

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

Data Monitoring Committee Appointed Indicator

Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.

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