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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. 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.

   field becomes available.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.

   Field Label	Description/Instructions
   Studies a U.S. FDA-regulated Drug Product*If (TBD), select Yes. Otherwise, select No.	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 If (TBD), 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*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. If you select Yes in this field, the Post	Include Page Regulatory Unapproved Uncleared field - Include 20170414 Regulatory Unapproved Uncleared field - Include 20170414
   Post Prior to U.S. FDA Approval or Clearance
   Post Prior to U.S. FDA Approval or Clearance	If (TBD), select Yes. Otherwise, select No.
   	Include Page Regulatory Post Prior field - Include 20170414 Regulatory Post Prior field - Include 20170414
   Pediatric Post-market SurveillanceIf (TBD), select Yes. Otherwise, select No.	Include Page Regulatory Pediatric field - Include 20170414 Regulatory Pediatric field - Include 20170414
   Product Exported from the U.S.If (TBD), select Yes. Otherwise, select No.	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 Indicate whether the trial is regulated by the FDA by selecting Yes or No.
   Note

   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.

   NoteIf you indicated that the trial is applicable under Section 801, you are required to complete the Delayed Posting field.

   Include Page
   Regulatory Section 801 field - Include 20170414 Regulatory Section 801 field - Include 20170414

   Data Monitoring Committee Appointed Indicator

   Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.

   InfoThis 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.

   Include Page
   Regulatory DMC Appointed field - Include 20170418 Regulatory DMC Appointed field - Include 20170418