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Comment: For CTRPMICRO-11, revised based on ClinicalTrials Final Rule - Data Elements Requirements.xlsx.

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  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.

    Availability of Expanded AccessIf an experimental drug or device is available outside any clinical trial protocol, select Yes.

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

  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.