The tabs in the Details pane are described below. If you do not see one of the tabs, select it from the Go menu.
Details displays information for the sequence, module, or file reference that is selected from the Navigation pane.
In the example below, section 3.2.P.5.2 is selected in the Navigation pane. Note that the section itself appears along with file references contained directly in the selected section.
Inventory displays all child files contained within the selected file reference or section and based on the specified view.
For example, if Life Cycle view is selected, Inventory will show all files from any sequence belonging to the selected section or subsection. Each file is displayed as a row in the grid.
The main difference between Details and Inventory is that only file references appear in the Inventory grid. Sections and node extensions will not appear.
In this example:
An Annual report (Sequence 0004) is selected in the Navigation tree in Regulatory Activity In view.
The Inventory tab displays all of the files contained in the Annual Report, both current and replaced or deleted files.
The Inventory tab is useful for seeing all documents contained within a specific application, module or section, removing the need to click through the embedded sections of tree to review submission contents.
When examining the contents of a study, choose the folder with the study ID and
title in any view. Use Life Cycle or Current view if you have modified a study and want to see all study related documents.
When examining the contents of a module, choose the module for a specific sequence in Sequence or Regulatory Activity view, or cumulatively in Life Cycle or current view.
When reviewing the contents of a specific portion of Module 3, such as Drug Substance or Drug Product. Click on either 3.2.S or 3.2.P. If you have multiple substances, dosage forms, etc., you can review them individually.
If you find a document in the Inventory tab and would like to see where it is located in
the tree, select the document and then choose Locate from the Action or context menu.
Annotations allows users to enter comments on documents. These comments are only available inside of Review and do not modify the output of the submission. See “Annotations” for more details.
Search allows users to search text, such as file name, leaf title, etc. See “Search” for more details.
Print displays the batch of documents. See “Print” for more details.
Download is for copying document files to a local drive. See “Download Files” for more details.
CrossCheck allows for a faster quality review of information about bookmarks and hyperlinks, including link destinations and placement in source documents. See “CrossCheck” for more details.
Relationships is useful for viewing information about a file reference’s relationships to other file references throughout the entire application.
The tab is divided into two sections:
File References that I Replace, Append to, Link to, Delete, or Reactivate contains the relationship type, CTD section, and file information (title and sequence information) for all files references that are performing an eCTD relationship to another document.
File References that Replace, Append to, Link to, Delete, or Reactivate me contains the relationship type, CTD section, and file information (title and sequence information) for all files references that have an eCTD relationship applied to it.
The following example shows a Section 2.2 Introduction file reference submitted in
Sequence 0002. It replaced a file in sequence 0000, and in turn was replaced by a file in Sequence 0003.
