Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.
The system will not display this section if you indicated that you do not require an XML document for ClinicalTrials.gov.
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 fields.
Instructions for recording regulatory information
Field Label | Description/Instructions |
---|---|
FDA Regulated Intervention Indicator* | Indicate whether the trial is regulated by the FDA by selecting Yes or No. 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. 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:
To change this indicator’s value, submit a request to the CTRO at ncictro@mail.nih.gov. |
Data Monitoring Committee Appointed Indicator | Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No. 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. |