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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. 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
Field Label | Description/Instructions |
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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.
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You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE. |
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.
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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.
Data Monitoring Committee Appointed Indicator
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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Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.