NIH | National Cancer Institute | NCI Wiki  

WIKI MAINTENANCE NOTICE

Please be advised that NCI Wiki will be will be undergoing maintenance on Monday, June 24th between 1000 ET and 1100 ET.
Wiki will remain available, but users may experience screen refreshes or HTTP 502 errors during the maintenance period. If you encounter these errors, wait 1-2 minutes, then refresh your page.

If you have any questions or concerns, please contact the CBIIT Atlassian Management Team.

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 10

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version 11

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
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.

...

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.