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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
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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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Post Prior to U.S. FDA Approval or Clearance | Include Page | | Regulatory Post Prior field - Include 20170414 | Regulatory Post Prior field - Include 20170414 | 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. Note | 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. |
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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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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:
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov. | |||||||||||
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Data Monitoring Committee Appointed Indicator |
| Data Monitoring Committee Appointed Indicator | Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No. Info | |