NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Old Version 8

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

Saved on

compared with

New Version Current

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

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Revised link to be consistent.

Anchor
submittrialregulatory
submittrialregulatory
Complete this section only if you indicated that you require an XML document to register your trial with ClinicalTrials.gov.

...

ClinicalTrials.gov.

HTML Comment
hiddentrue

Screenshot TBD.

 

How to Complete the Regulatory Information Section

Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. For a definition of each field. See the ClinicalTrials.gov Protocol Data Element Definitions for definitions for these fields, refer to http://prsinfo.clinicaltrials.gov/definitions.html.

Instructions for recording regulatory information

Pediatric Post-market SurveillanceYou 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.

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.

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 readonly - Include 2017041420170508
Regulatory Unapproved Uncleared field readonly - 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.

20170508

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*

Indicate whether the trial is regulated by the FDA by selecting Yes or No.

Note
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
note

If you indicated that the trial is applicable under Section 801, the Delayed Posting Indicator field becomes available and defaults to No. 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.

Data Monitoring Committee Appointed Indicator

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

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