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
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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.)
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 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.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*
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 you select Yes in this field, the Section 801 Indicator field becomes available.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.
Data Monitoring Committee Appointed Indicator
Optionally, if a data monitoring committee has been appointed for this trial, select Yes. Otherwise, select 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.
