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 optional for Abbreviated trials.
Check out the trial before you begin abstraction
Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.
How to Abstract Regulatory Information
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
On the Administrative Data menu, under Regulatory Information, click Regulatory Information.
The Regulatory Information page appears.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.
Field Label
Description/Instructions
Studies a U.S. FDA-regulated Drug Product* If (TBD), select Yes. Otherwise, select No. Studies a U.S. FDA-regulated Device Product* If (TBD), select Yes. Otherwise, select No. Delayed Posting Indicator*
Indicate whether the release of trial information on Cancer.gov is being delayed until after an interventional device has been approved or cleared by selecting Yes or No.
Select No if the trial does not include a device.Post Prior to U.S. FDA Approval or Clearance If (TBD), select Yes. Otherwise, select No. Pediatric Post-market Surveillance If (TBD), select Yes. Otherwise, select No. Product Exported from the U.S. If (TBD), 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.
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*
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, you are required to complete the Delayed Posting field.
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.
- To save the details you have abstracted, click Save.
