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There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.

FDA IND IDE section of the Register Trial pageImage Removed
HTML Comment
hiddentrue

Screenshot TBD.

 

How to Register IND/IDE Trials

  1. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.

    Instructions for recording IND/IDE Information

    Field Label

    Description/Instructions

    IND/IDE Types*

    If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational Device Exemption, select IDE.

    IND/IDE Number*

    Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)

    Tip
    titleIND number formats

    You can enter the IND number in many formats. For example, for a biologics (BB) IND that contains the number 1234, you can type BB1234, 1234, or BB_1234.
    For IDE trials, type the IDE number associated with the grant.

    IND/IDE Grantor*

    Select one of the following organizations that holds the IND/IDE approval:

    1. For IND trials:
      1. Center for Drug Evaluation and Research
      2. Center for Biologics Evaluation and Research
    2. For IDE trials:
      1. Center for Devices and Radiological Health
      2. Center for Biologics Evaluation and Research

    IND/IDE Holder Type*

    Select one of the following holder types:

    1. Investigator
    2. Organization
    3. Industry
    4. NIH
    5. NCI

    NIH Institution, NCI Division/Program Code* (required if the holder type is NIH or NCI)

    Select a code from the drop-down list.

    • If you selected NIH from the IND/IDE Holder Type list,
    see
    Codes
    • Code Values for valid values.
    • If you selected NCI from the IND/IDE Holder Type list,
    see
    /
    Codes
    • Values for valid values.
      Anchor
      indcodes
      indcodes

    Availability of Expanded Access

    ?

    If an experimental drug or device is available outside any clinical trial protocol, select Yes.

    Expanded Access Type* (required if you selected the Yes check box in the Expanded Access? column)

    Select one of the following access types:

    1. Available - Expanded access is currently available for this treatment
    2. No Longer Available - Expanded access was available for this treatment previously but is not currently available and will not be available in the future
    3. Temporarily not available - Expanded access is not currently available for this treatment, but is expected to be available in the future
    4. Approved for Marketing - This treatment has been approved for sale to the public

    Exempt?

    Include Page
    IND IDE Availability of Expanded Access field - Include 20170414
    IND IDE Availability of Expanded Access field - Include 20170414

    Expanded Access Record

    Include Page
    IND IDE Expanded Access Record field - Include 20170414
    IND IDE Expanded Access Record field - Include 20170414

    Select the Yes check box in the Exempt? column if the investigational product does not require FDA approval .

  2. Click Add IND/IDE.
  3. To delete an IND/IDE record from a trial, in the Action column, click Delete.
  4. Optionally, to add another IND/IDE record, repeat the steps above.