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Regulatory information includes human subject safety review and IND/IDE data. Some fields in this section are visible only when you have selected Yes or No indicators in preceding fields. Other fields may be visible but may not contain indicators. Regulatory information is required for Complete trials that will be submitted to ClinicalTrials.gov. Regulatory information is optional for Abbreviated trials. 

How to Abstract Regulatory Information

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. Check

   On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. On the Administrative Data menu, under Regulatory Information, click Regulatory Information.
   The Regulatory Information page appears.

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5. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field for Complete trials only.

   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
   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 - Include 20170414 Regulatory Unapproved Uncleared field - Include 20170414
   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	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 If the trial is regulated by the FDA, select Yes. (If the trial includes an IND or IDE, you must select Yes.) Otherwise, select No. 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*	Include Page Regulatory Section 801 field - Include 20170414 Regulatory Section 801 field - Include 20170414
   Data Monitoring Committee Appointed Indicator Optionally, if a data monitoring committee has been appointed for this trial, select Yes. Otherwise, select No.
   Info
   Include Page Regulatory DMC Appointed field - Include 20170418 Regulatory DMC Appointed field - Include 20170418

6. To save the details you have abstracted, click Save.