Calyx RIM Viewing 5.5 User Guide

TOC Hierarchy

The table of contents (TOC) is always displayed in a hierarchical, or tree view. The Module appears at the very top of the hierarchy; and Sections, Sub-sections, Node Extensions, and STF are displayed following the DTD structure.

Item Icon
Module
Section/Sub-Sections
Study Tagging File (STF)
Node Extension (NE)
STF: File Tag
STF: Site
Document

Document-specific icon based on user settings (when available).

Unknown or not defined.

Document Cross Reference
Operation: New
Operation: Append
Operation: Replace
Operation: Delete

The TOC items (Modules, Sections, Node Extensions, STF and Sites) can be expanded or collapsed  in several different ways:

  • Clicking in the TOC will expand the item.

  • Clicking in TOC will collapse the item.

  • Double-clicking on the item (on text only) will expand all submission items to the document level.

  • Double-clicking on the expanded item (on text only) will collapse the clicked item.
  • Selecting a document in the TOC will display that document in the document viewer. The Lifecycle and Properties information for that document will be populated in their respective windows.

Note: For FDA 3.3 submissions, the Form FDA 356h and Form FDA 1571 section/document will not be displayed under the TOC. The document link will be displayed under Administrative Information.

For China NMPA submissions (starting from Calyx RIM Viewing 5.5 CHF 5) a new feature that translates the names of TOC folders is included. Moving a mouse pointer over Module 1 shows the Chinese text in English and moving a mouse pointer over Modules 2-5 shows the English text in Chinese.