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Comment: Deleted row for "Post Prior to U.S. FDA Approval or Clearance" field based on clarification from Michael Izbicki. The field will never be available during initial registration of a trial, because the Unnaproved/Uncleared Device field is read-only.

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Pediatric Post-market Surveillance

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

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
Include Page
Regulatory Post Prior field - Include 20170414Regulatory Post Prior field - Include 20170414

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

Section 801 Indicator*

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.

Info

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.