NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Old Version 2

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: Clarified checkout step.

Complete trials that will be submitted to ClinicalTrials.gov. Regulatory information is optional for Abbreviated trials. 

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.

Multiexcerpt
MultiExcerptNameabstractregulatory

Anchor
abstractregulatory
abstractregulatory

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

Regulatory information includes human subject safety review and IND/IDE data. Some fields in this section are visible only when you have selected YES Yes or NO No indicators in preceding fields. Other fields may be visible but may not contain indicators. Regulatory information is optional required for Abbreviated trials.

Anchor
61276127
Info
titleCheck out the trial before you begin abstraction
HTML Comment
hiddentrue

Screenshot TBD.

  • 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.

    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

    FDA Regulated Intervention Indicator*

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

    Note

    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.

    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.

    Note

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

    Delayed Posting Indicator*

    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.

    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

    Post Prior to U.S. FDA Approval or Clearance

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

    Pediatric Post-market Surveillance

    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

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

    Data Monitoring Committee Appointed Indicator

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

    Info
  • To save the details you have abstracted, click Save.