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Views Pane

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Written by Amy Chen

Views are different ways of looking at the content of an application. These views can be split into two categories, modular and sequential.

  • Modular Views use the eCTD structure as the base for the structure- documents will show in these views first by module, and will show documents regardless of the sequence or submission they were submitted in.

    • Modular views are most helpful for higher level looks at the application as a whole and include Life Cycle and Current views.

  • Sequential Views first break down the application by sequence. It will show information that was submitted in each sequence.

These views are most useful in reviewing submissions as they are being submitted to

a health authority and include Sequence, Regulatory Activity, and Origin views.

Selecting a view can be done using the Go menu or in the bottom left area of the Review window.

See “Additional Information on Views” for more details.

Modular Views

The modular views will show the application based on the five different modules of the eCTD tree initially and will show information regardless of the sequence where the file reference was added. Modular views include:

  • Life Cycle

  • Current

Life Cycle

Life Cycle is a cumulative view and displays every document submitted in eCTD modules 1–5, plus any Orphaned Files, if applicable, regardless of the sequence of submission or life cycle status of the file references.

Within each module, information for the entire application is contained, including the original application and any additional amendments or supplements.

In the Navigation pane above, the File Reference Group icon for the Introduction

(eCTD section 2.2) has been selected. In Life Cycle view, this icon represents all files, past and present, for this section. Note that there are 4 related file references. The introduction, originally submitted in 0000 was replaced in sequence 0002, 0003, and finally in 0004, which is the document that is currently considered by the respective health authority.

Current

Current view displays all eCTD elements in the application that have not been replaced or deleted. This view is the most useful in verifying the status of the application from a high level and ensuring that documents have had the correct lifecycle operators.

References will show in this view regardless of the submission in which the document was submitted.

Review_Current

Using the same example from the previous section, in the Current view, the Introduction document from sequences 0000, 0002, and 0003 no longer appear, and only the document from sequence 0004 is present.

Sequential Views

Sequential views allow a reviewer to see content initially broken down by sequence. These views are useful for QCing submissions on a more granular level. Sequential views include:

  • Sequence

  • Regulatory Activity

  • Origin

Sequence

Sequence view displays all application sequences. The order can be modified by using the icon to sort ascending or descending.

Review_SequenceView

In this example, the sequence 0003 (an Efficacy Supplement) is selected and the Nomenclature of Stepoxin document is shown within section 3.2.S.1.1.

The Details tab displays the selected file reference Nomenclature of Stepoxin. The Preview pane displays the contents of the associated file.

Regulatory Activity

The Regulatory Activity view displays each regulatory activity (such as an original application, supplement, annual report, variation, or line extension) grouped with its supporting submissions, such as amendments.

In the following example, in the Navigation pane, an Efficacy Supplement contains a file reference Nomenclature of Stepoxin within section 3.2.S.1.1.

Review_RegActivity

The Details tab displays the selected file reference Nomenclature of Stepoxin. The Preview pane displays the contents of the associated file.

Note that Regulatory Activity is highlighted at the bottom of the Navigation pane, indicating the view displayed.

Origin

Origin view displays sequence with all elements (sections and file references) in the exact order that was used in the published XML. It is set up similar to the Sequence view, however if CrossCheck is licensed, Origin view will also contain error codes and color-coordination to highlight validation errors contained within the documents or sections.

Review_Origin

In this example, in the Navigation pane, an Efficacy Supplement contains a file reference Nomenclature of Stepoxin within section 3.2.S.1.1.

The Details tab displays the selected file reference Nomenclature of Stepoxin. The Preview pane displays the contents of the associated file.

Additional Information on Views

File Ordering throughout the Views

Sections and file references in all views but Origin are harmonized so that the file reference order is consistent between views. The following rules are used to determine order.

  1. Rule 1: The earliest sequence defines the order of the documents. When a later

    sequence submits a newer document, it will appear at the end of list.

  2. Rule 2: An appending document will always appear immediately before the leaf it

    appends.

  3. Rule 3: If a document has been replaced in a different section, both the new document and the replaced document will appear in the most recent section. This can happen after moving to a DTD version, if the newer DTD changed where a leaf reference is located.

Orphaned Files

All views display orphaned files as an additional node parallel to and after the five eCTD modules. References will appear in the Orphaned Files node if a document is contained within the output location, but that file is not referenced in the backbone.

In the following example, a file called “test render.xls” exists in the folder path 0000/m1/22-intro but is not shown in the XML.

Review_OrphanedFiles
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