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 |
|---|---|
| Studies a U.S. FDA-regulated Drug Product* | If the trial studies one or more U.S. FDA-regulated drug or biologic products (a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act), select Yes. Otherwise, select No. |
| Studies a U.S. FDA-regulated Device Product* | If the trial studies one or more U.S. FDA-regulated device products (a device subject to section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act), select Yes. Otherwise, select No. If you select Yes in this field, the Unapproved/Uncleared Device field and Pediatric Post-market Surveillance field become available. |
Unapproved/Uncleared Device* | If the release of trial information on Cancer.gov is being delayed until after an interventional device has been approved or cleared, select Yes. Otherwise, select No. Select No if the trial does not include a device. If you select Yes in this field, the Post Prior to U.S. FDA Approval or Clearance field becomes available. 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. |
| Post Prior to U.S. FDA Approval or Clearance | If the responsible party authorizes posting of the study record on ClinicalTrials.gov prior to U.S. FDA approval/clearance of device product, select Yes. Otherwise, select No. |
| Pediatric Post-market Surveillance | If the U.S. FDA has ordered a pediatric post-market surveillance of the device product, select Yes. Otherwise, select No. |
| Product Exported from the U.S. | If the product is manufactured in the U.S. or one of its territories and exported for study in a clinical trial in another country, select Yes. Otherwise, select No. |
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* | If the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801, select Yes. Otherwise, select 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. |
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. |
