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Columns Available on Details and Inventory Tabs

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Written by Amy Chen

The following columns are displayed by default.

  • Reviewed — Indication of whether the section or file reference element has been reviewed.

  • Title — Section or file reference title.

  • Submitted in — Sequence in which file reference was submitted.

  • Life Cycle Status — File reference status (current, replaced, amended by, amended to, or deleted).

  • Reserved By — The name of the person who has reserved this file for editing.
    Will be empty if you are not using Publish.

  • State — State of the Regulatory Activity, Sequence, Section or File reference.
    Values depend on what type of element is being displayed. Will be empty if you are not using Publish.

  • Section Number — The CTD section number.

  • Section — The CTD section name.

  • File Name — Name of physical file associated with the file reference.

  • Extension — Windows extension indicating the type of file. Examples include.xpt or .pdf.

  • Section Path — The full TOC path to the section.

  • Size (KB) — File size in kilobytes.

  • Page Count — Number of pages in the associated file.

  • Type — Type of element such as Section, File reference, etc. Will be empty if you are not using Publish.

  • Application — The other applications that this document was used in. If a document is used in a single application, this cell will display “ALL”.

  • Received Date — Date on which the regulatory authority received this document first. This cell will populate only if your organization is a regulatory authority.

The following columns are not displayed by default, but can be added to the display.

  • Links — Number of links in file.

  • Broken Links — Number of broken links in file.

  • Bookmarks — Number of bookmarks in file.

  • Broken Bookmarks — Number of broken bookmarks in file.

  • File Status — Transfer status of the file from the source location to the Published output location.

  • Module — The CTD module.

  • ID — Unique file reference identifier assigned by the applicant.

  • Path — Full path to the source file relative to the application folder.

  • Format — MIME type.

  • Version — Version assigned by the applicant, if any. May be used by your publishing tool, but often not used.

  • Checksum — The checksum value for the file being submitted.

  • Checksum Type — The checksum algorithm used.

  • Language — File reference language.

  • Font Library — File font library.

    Reserved for Future Use by ICH. May be used by your publishing tool, but often not used.

    May be used by your publishing tool, but often not used.

  • Related ID — IDs of referenced files.

  • Related Titles — Titles of referenced files.

  • Related Files — XML reference of the file.

  • Operation — The ‘operation’ attribute value on the ‘leaf’ element in the xml file (index or regional).

Note: All columns except Reviewed are read-only. If you are using Publish, the Title, File Name, File Status, and State columns are editable if you have permissions.

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