Assembly Variable Maintenance

Variables are numeric or string values that may change throughout an assembly in Ennov InSight . The four types of variables are:

— Assembly repository variables

— Assembly system defined variables — Assembly user defined variables

— Ennov InSight assembly variables

Additional assembly user defined variables may be defined at the assembly level in publishing settings, and these may be defined separately for each output channel.

Variable Formatting

In an assembly, the variable name is formatted with a delimiter, such as $VARIABLE or ${VARIABLE}. The $ {VARIABLE} form is required if there is no space between the variable and any literal text that follows, such as: $

{VNAME}, pg $VR.

Because only documents are mapped from a repository, the variable is resolved by using the current assembly as the starting point for its definition and searching down through the tree until it finds a bound document of the correct doctype, or by searching up to the first parent.

Variables are resolved in a leaf element to the first assigned document, and the publishing elements search for their parent and resolve from there. If the publishing element is not assigned to a document, it should follow the rules for searching the tree (as described above).

In a publishing template file (overlay, cover page), the variable name is formatted with an angle bracket delimiter, for example: <VARIABLE>. This can be used in overlay or cover page templates. The variable is resolved by using the current assembly as the starting point for its definition. These variables are not resolved in the body matter or content of the output, but only on the cover page and on the overlay.

Note: The variable code cannot contain spaces. However, spaces are permitted between the variable code and the delimiters.

Assembly Repository Variables

Assembly repository variables are used to pull document attributes from the repository for use in a submission.

For example, the repository author variable returns the value for the mapped author name of the source documents bound to the assembly. Assembly repository variables are set up and maintained in data administration.

When you create an assembly repository variable, keep in mind the following:

— If you enter a value for Repository Attribute Name but not for Document Type, the variable resolves to the closest assigned repository document in the assembly. The variable resolves to the value of the repository attribute name that matches the name you enter.

— If you enter values for both Repository Attribute Name and Document Type, the variable resolves to the closest assigned repository document in the assembly that matches the document type you enter. Once that document is found, the variable resolves to the value of the repository attribute name defined in that document type that matches the name you enter.

Assembly Repository Variable Attributes

You can use the attributes to describe the assembly repository variables.

Attribute Description
Description Free form text that helps describe the value.
Document Type Identifies the type of object for which this variable should be used. For example: dm_object.
Variable Code

Ennov InSight code for the variable. When used in Ennov InSight for XML or paper publishing resolution, this code, prefaced by a $, is used. When included in an overlay or cover page document, this code is surrounded by angle brackets (<, >).

Cannot include spaces. Examples: Duration, Route, and Species.

Variable Name

A descriptive name to identify the variable in Ennov InSight . Examples:

LL_Duration, LL_Route, LL_Species, DM_Duration, DM_Route and DM_Species.

Variable Value Name of the attribute as it is displayed in the DMS repository interface. It should not include category information for OpenText repository variables. Examples: eCTD_Duration, eCTD_Route_of_Administration, and eCTD_Species.

Assembly Repository Variable Values

You can use the variables to automatically insert assembly repository data into your document.

Variable Name

Variable

Code

Document Type Repository Attribute Description Active Flag
Repository Author RSA null Author The author of the mapped document; repeating attribute; returns a comma delimited list Active
Repository Subject RSS null Subject The subject of the mapped document Active

Configure Ennov InSight Repository Variables

Use this procedure to create repository variables in Ennov InSight .

To create repository variables:

  1. In Ennov InSight , go to Data Administration.
  2. Click Assembly Repository Variables.
  3. For each repository server attribute that you would like to use, create a new repository variable. a) Click the Create icon.
    1. Populate the fields.
    2. Click Save.

      The new variable appears on the Assembly Repository Variables page.

  4. Update the propertyMappings.xml file on the Ennov InSight application server.

Assembly System-Defined Variables

Assembly system-defined variables are preconfigured in Ennov InSight . While you can change the name of a systemdefined variable, the value to which the variable resolves cannot be changed. System-defined variables resolve to values calculated during publishing or prepare for publishing.

InSight System-Defined Variables

Ennov InSight uses system-defined variables to automatically insert data into documents.

The following descriptions are relevant to a number of the variables in this table:

Word/Phrase Description
Division Divisions, like Volumes, function independently from the assembly folder hierarchy.
Major Division A Major Division starts at a folder marked as a Major Division and ends at the next folder marked as a Major Division, regardless of its position in the folder structure.
Minor Division A Minor Division starts at a folder marked as a Minor Division and ends at the next folder marked as a Minor Division or Major Division, regardless of its position in the folder structure.
Word/Phrase Description
Publishing time variables Publishing time variables can be stamped only on: cover pages and overlays, published tabs (not preview), TOC right column text, paper cross-reference link text. They cannot be used within other variables.
Paper Publishing time variables Publishing time variables that are available during a paper channel publish only.
Variable Name

Variable

Code

Description Active Flag Constraints

Abbreviated

Major Division

Name

MABBR The Abbreviated Name attribute defined on the folder element in the assembly that has been selected to be a major division. For eCTD, this is an abbreviated form of the eCTD module name (Qual.). For other submission types, this is the Item. Active There must be major division folder assigned somewhere above the ancestor tree, with a nonblank abbreviated name.

Abbreviated

Minor Division

Name

NABBR The Abbreviated Name attribute defined on the folder element in the assembly that has been selected to be a minor division. For eCTD, this is an abbreviated form of the eCTD section name (Drug Prod). For other submission types, this is the section. Active There must be minor division folder assigned somewhere above the ancestor tree, with a nonblank abbreviated name.

Assembly

Name

ANAME The name of the assembly as defined by the user. Active

Assembly

Relative Major

Division

Number

ARM Major divisions number relative to the assembly. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree, with a non-blank number.

Assembly

Relative Page

ARP Page number in the paper channel relative to the entire assembly. Active Publishing time variable.

Assembly

Relative Page

ARE Page number in the electronic channel relative to the entire assembly. Active Publishing time variable.
Variable Name

Variable

Code

Description Active Flag Constraints

Assembly

Relative

Volume

Number

ARV The volume count relative to the current assembly. Active

Paper Publishing time variable.

Must be within a defined volume.

Assembly

Total Major

Divisions

ATM Total major divisions in assembly. Active Publishing time variable.
Assembly Total Pages ATP The total number of paper channel pages in the assembly. Active Publishing time variable.
Assembly Total Pages ATE The total number of electronic channel pages in the assembly. Active Publishing time variable.
Blank BL A blank character, used to resolve a variable to a blank. Active
Current Date CD Current date and time. Active

Current date {CD} will not work for

$DATETIME

patterns. Use Current time {CT} to produce equivalent results.

Current

Document

Version

DV Current document version. Active Must be used on a document assigned from a DMS repository (no filesystem).
Current Time CT Current date and time. Active Must be used within the date format function $DATETIME.
Document Name DNAME The Name attribute defined on the document element in the assembly. Active Must be used somewhere under a document that has a defined name.
Document Number DN The Number attribute defined on the document element in the assembly. Active Must be used somewhere under a document that has a defined number.
Variable Name

Variable

Code

Description Active Flag Constraints

Document

Relative Page

DRP Page number in the paper channel relative to the current document (including TOC and cover pages that are included in page numbering). Active Publishing time variable.

Document

Relative Page

Number

DRE

Page number in the electronic channel relative to the current document

(including TOCs and cover pages that are included in page numbering.

Active Publishing time variable.
Document Total Pages DTE The total number of electronic channel pages in the current document. Active Publishing time variable.
Document Total Pages DTP The total number of paper channel pages in the current document. Active Publishing time variable.

Element

Abbreviated

Name

ABBR

The current element abbreviated name.

For Volume and Page Marker entities,

ABBR resolves to the NAME of the entity.

Active There must be a defined, abbreviated name on the current element. For a TOC or Tab, this resolves to the Abbreviated Name (or NAME) of the entity where the special sheet is attached.
Element Name NAME The current element name. Active

There must be a defined name on the current element. For a TOCs or Tab, this resolves to the NAME of the entity where the special sheet is physically located.

Cover Pages resolve to the NAME field attribute on the Cover Page entity. If no value is entered in the NAME field attribute of the Cover Page, this variable is not resolved.

Variable Name

Variable

Code

Description Active Flag Constraints
Element Number N The current element number. Page Markers do not have a Number Attribute. Active There must be a defined number on the current element. For a TOC or Tab, this resolves to the NUMBER of the entity where the special sheet is attached. N does not resolve on Cover Pages.
Element Title TITLE

The current element title.

For Volume, Folder, and Page Marker entities, TITLE resolves to the NAME of the entity.

Active

There must be a defined TITLE on the current element. For a Tab, this resolves to the TITLE (or NAME) of the entity where the Tab is attached.

For a TOC, this resolves to the TITLE field on the TOC entity (from the TOC attributes).

The TITLE variable does not resolve for Cover Pages.

File Relative Page Number FR Page number relative to the current assigned file (TOC or cover page); or portion of a document between any special sheet or volume. Does not include any publication elements such as TOC or cover page. Active Publishing time variable.

File Total

Pages

FT Total number of pages in the current assigned file (TOC or cover page); or portion of a document between any special sheet or volume. Active Publishing time variable.
Variable Name

Variable

Code

Description Active Flag Constraints

Leaf

Abbreviated

Name

LABBR The abbreviated name on the current leaf. Active Will work on any element assigned under a leaf.
Leaf Name LNAME The Name attribute defined on the leaf element in the assembly. Active Will work on any element assigned under a leaf.
Leaf Number LN The Number attribute defined on the leaf element in the assembly. Active Will work on any element assigned under a leaf.
Leaf Output File Path LOP Actual output path of the leaf parts may be overridden by user but in general this is calculated; path should be the relative path starting at the publish destination (minus the application and sequence number), for example coverletter.pdf path would be ./M1/US/ and the path and file name would be ./M1/US/cover-letter.pdf Active Will work on any element assigned under a leaf.
Leaf Output Filename LOF Actual output file of leaf determined by user but also may be calculated at publishing time Active Will work on any element assigned under a leaf.

Leaf Relative

Page

LR Page number in the electronic channel relative to the current leaf. This variable numbers electronic channel pages only. Active Publishing time variable. Will work on any element assigned under a leaf.

Leaf Total

Pages

LT Total number of pages contained in the leaf. This variable totals electronic channel pages only. Active Publishing time variable. Will work on any element assigned under a leaf.

Major Division

Name

MNAME The Name attribute defined on the folder element in the assembly that has been selected to be a major division. For eCTD, this is the eCTD module name (Quality). For other submission types, this is the Item. Active There must be major division folder assigned somewhere above the ancestor tree, with a nonblank name.
Variable Name

Variable

Code

Description Active Flag Constraints

Major Division

Number

MN The Number attribute defined on the folder element in the assembly that has been selected to be a major division. For eCTD, this is the eCTD module number (3). For other submission types, this is the item. Active

Major Division

Relative Minor

Division

MRN The count of the current minor division relative to the current major division. Active Publishing time variable. There must be both a major division folder and a minor division folder assigned somewhere above the ancestor tree.
Major Division Relative Page MRP Page number in paper channel relative to the current major division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.
Major Division Relative Page MRE Page number in the electronic channel relative to the current major division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.

Major Division

Relative

Volume

Number

MRV The current volume number relative to the current major division. Active

Paper Publishing time variable. There must be a volume defined, and there must be major

division folder assigned somewhere above the ancestor tree.

Variable Name

Variable

Code

Description Active Flag Constraints

Major Division

Total Minor

Divisions

MTN The total minor divisions in the current major division. Active Publishing time variable. There must be both a major division folder and a minor division folder assigned somewhere above the ancestor tree.
Major Division Total Pages MTP Total number of paper channel pages contained in the major division. Active

Publishing time variable. There must be major division

folder assigned somewhere above the ancestor tree.

Major Division Total Pages MTE Total number of electronic pages contained in the major division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.
Major Division Total Volumes MTV The total volumes in the current major division. Active

Paper Publishing time variable. There must be a volume defined, and there must be major

division folder assigned somewhere above the ancestor tree.

Minor Division

Name

NNAME The Name attribute defined on the folder element in the assembly that has been selected to be a minor division. For eCTD, this is the eCTD section name (Drug Product). For other submission types, this is the section. Active There must be minor division folder assigned somewhere above the ancestor tree, with a nonblank name attribute.
Variable Name

Variable

Code

Description Active Flag Constraints

Minor Division

Number

NN The Number attribute defined on the folder element in the assembly that has been selected to be a minor division. For eCTD, this is the eCTD section (3.2.P). For other submission types, this is the section. Active

There must be a

major division folder assigned somewhere above the ancestor

tree, with a nonblank number attribute.

Minor Division Relative Page NRE Page number in the electronic channel relative to the current minor division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.
Minor Division Relative Page NRP Page number in the paper channel relative to the current minor division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.

Minor Division

Relative

Volume

Number

NRV The current volume number relative to the current minor division. Active

Paper Publishing time variable. There must be a volume defined, and there must be minor

division folder assigned somewhere above the ancestor tree.

Minor Division Total Pages NTE Total number of electronic channel pages contained in the minor division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.
Minor Division Total Pages NTP Total number of paper channel pages contained in the minor division. Active Publishing time variable. There must be major division folder assigned somewhere above the ancestor tree.
Variable Name

Variable

Code

Description Active Flag Constraints
Minor Division Total Volumes NTV The total volumes in the current minor division. Active

Paper Publishing time variable. There must be a volume defined, and there must be minor

division folder assigned somewhere above the ancestor tree.

Referenced

Leaf

Application

Code

RLAC For a Reference Leaf, this is the Application Code of the Application containing the referenced leaf. Active

Referenced

Leaf Leaf

Name

RLLNAME For a Reference Leaf, this is the Name attribute defined on the Leaf element of the referenced leaf. Active Will work on any element assigned under a leaf.

Referenced

Leaf Major

Division Name

RLMNAME For a Reference Leaf, this is the Name attribute defined on the Folder element containing the referenced leaf that has been selected to be a major division. For eCTD, this is the eCTD module name (Quality), for other submission types, this is the Item. Active There must be major division folder assigned somewhere above the ancestor tree, with a nonblank name.

Referenced

Leaf Major

Division

Number

RLMN For a Reference Leaf, this is the Number attribute defined on the Folder element containing the referenced leaf that has been selected to be a major division. For eCTD, this is the eCTD module number (3), for other submission types, this is the Item. Active

Referenced

Leaf Minor

Division Name

RLNNAME For a Reference Leaf, this is the Name attribute defined on the Folder element containing the referenced leaf that has been selected to be a minor division. For eCTD, this is the eCTD section name (Drug Product), for other submission types, this is the section. Active There must be minor division folder assigned somewhere above the ancestor tree, with a nonblank name attribute.
Variable Name

Variable

Code

Description Active Flag Constraints

Referenced

Leaf Minor

Division

Number

RLNN For a Reference Leaf, this is the Number attribute defined on the Folder element containing the referenced leaf that has been selected to be a minor division. For eCTD, this is the eCTD section (3.2.P), for other submission types, this is the section. Active

There must be major division folder assigned somewhere above the ancestor

tree, with a nonblank number attribute.

Referenced

Leaf Sequence

Number/Code

RLSC

For a Reference Leaf, this is the

Sequence Number/Code of the Sequence containing the referenced leaf.

Active

Referenced

Leaf Volume

Number

RLVN For a Reference Leaf, this is the Volume Number found on the Volume element containing the referenced leaf which is set by volumization. Active
Source Filename DFNAME The source file name according to the assigned document. Active Must be under an assigned document.
Space SP A single-space character, used to buffer other values or to resolve a variable to a blank. Inserts a Space into a variable string, which are normally removed from the beginning and end of evaluated variables. Active
Total Volumes ATV The total number of volumes in the assembly. Active Paper Publishing time variable
Volume Name VNAME The name of the current volume. Active Must be in a defined volume.
Volume Number VN Volume number found on volume element which is set by volumization. Active Must be in a defined volume.

Volume

Relative Page

VR Page number relative to the current volume. This variable numbers paper channel pages only. Active Paper Publishing time variable.
Volume Total Pages VT Total number of pages contained in the volume. This variable totals paper channel pages only. Active Paper Publishing time variable.

Assembly System-defined Variables Attributes

You can use these attributes to describe the assembly system defined variables.

Attribute Description
Variable Name Name of System Variable used. Examples: Abbreviated Major Division Name, Assembly Relative Page.
Last User Updated Defines by whom the Data Administration value was created. By default, this option is read-only.
Last Changed Date Defines when the Data Administration value was created. By default, this option is read-only.
Active Indicates if the entity is active or inactive.

Ennov InSight Assembly Variable Values

You can define variables for Ennov InSight Assemblies in Data Administration.

The table lists all the variables that you can define for assemblies.

Variable

Name

Variable

Code

Last User Updated Last Changed Date Description Active Flag

Application

Code

IAC Username d-m-y Application code Active

Application

Internal

Code

IIC Application internal code Active

Application

Keywords

IAK Application keywords Active
Application Language IAL Application language Active

Application

Name

IAN

Application

name

Active

Application

Procedure

Type

IPT Application procedure type Active

Application

Type

IAT Application type Active
Assembly Category IASC Assembly category Active
Assembly Keywords IASK Assembly keywords Active

Variable

Name

Variable

Code

Last User Updated Last Changed Date Description Active Flag

Assembly

Name

INA Assembly name Active
Assembly Status IASS Assembly status Active
Assembly Subcategory IASSC Assembly subcategory Active

Country

Name

ICN Country name Active

Country

Regulatory

Authority

ICA Country regulatory authority Active
Event Code IEC Event code Active

Event

Keywords

IEK Event keywords Active
Event Name IEN Event name Active

Event

Sequences

IER Event sequences Active
Event Type IET Event type Active

Event

Variation

Number

IEV Event variation number Activ

Product

Dosage Form

IPF1 Product dosage form Active

Product

Family Code

IPC Product family code Active

Product

Family Name

IPN Product family name Active
Product Name 1 IP1 Product name 1 Active
Product Name 2 IP2 Product name 2 Active

Sequence

Keywords

ISK Sequence keywords Active

Sequence

Name

ISN Sequence name Active

Variable

Name

Variable

Code

Last User Updated Last Changed Date Description Active Flag

Sequence

Number/

Code

ISC Sequence number/code Active

Sequence

Status

ISS Sequence status Active
Sequence Status Date ISD

Sequence

status date

Active

Sequence

Submission

Filing Type

ISF

Sequence submission

filing type

Active

Assembly User-Defined Variables

User-defined variables may be added and modified in your project:

— By a publisher at the assembly level using Publishing Settings > Variables

— By a data administrator using Go To > Data Administration

At the assembly level, you can specify that a user-defined variable is used for the paper channel or the electronic output channel. If you want to use the same variable for both channels, you can define the same variable for each channel.

A user-defined variable you create at the assembly level must be unique so it does not conflict with a variable that is established in Data Administration. You can redefine a Data Administration-level user-defined variable to create an assembly-level user-defined variable. Assembly-level variables override Data Administration-level variables during publishing.

User-defined Variable Values

You can define the value for specific variables.

Variable Name Variable Code Variable Value Description Active Flag Variable Type
Company Name UCN Company Name Company name Active Single-line variable
Volume Name Formula VOLNAME V$Bates($VN, 6) Active Single-line variable

Assembly User-defined Variables Attributes

You can use these attributes to describe the assembly user defined variables.

Attribute Description
Variable Name A variable name. Example: Company Name.
Attribute Description
Variable Code The code for the variable. This is what will be used in a TOC, overlay, and elsewhere to refer to this variable.
Variable Value Value which will replace the variable code in the output.
Variable Type Defines the type of the variable. Possible values: Single-Line Variable, Multi-Line Variable.
Description Description of the variable.
Last User Updated Defines by whom the Data Administration value was created. By default, this option is read-only.
Last Changed Date Defines when the Data Administration value was created. By default, this option is read-only.
Active Indicates if the entity is active or inactive.

Ennov InSight Assembly Variables

Ennov InSight assembly variables resolve to attribute values stored in Ennov InSight , such as application name and assembly status. They are calculated during publishing or prepare for publishing.

Ennov assembly variables are preconfigured in Ennov InSight and cannot be modified in Data Administration. However, they can be reconfigured by the Ennov consulting organization.

Ennov InSight Assembly Variables Attributes

You can use these attributes to describe the Ennov InSight assembly variables.

Attribute Description
Variable Name A variable name.
Variable Code The code for the variable. This is what will be used in a TOC, overlay, and elsewhere to refer to this variable.
Variable Value Value which will replace the variable code in the output.
Variable Type Defines the type of the variable. Possible values: Single-Line Variable, Multi-Line Variable.
Description Description of the variable.
Last User Updated Defines by whom the Data Administration value was created. By default, this option is read-only.
Last Changed Date Defines when the Data Administration value was created. By default, this option is read-only.
Active Indicates if the entity is active or inactive.

Ennov InSight Assembly Variable Values

You can define variables for Ennov InSight Assemblies in Data Administration.

The table lists all the variables that you can define for assemblies.

Variable

Name

Variable

Code

Last User Updated Last Changed Date Description Active Flag

Application

Code

IAC Username d-m-y Application code Active

Application

Internal

Code

IIC Application internal code Active

Application

Keywords

IAK Application keywords Active
Application Language IAL Application language Active

Application

Name

IAN

Application

name

Active

Application

Procedure

Type

IPT Application procedure type Active

Application

Type

IAT Application type Active
Assembly Category IASC Assembly category Active
Assembly Keywords IASK Assembly keywords Active

Assembly

Name

INA Assembly name Active
Assembly Status IASS Assembly status Active
Assembly Subcategory IASSC Assembly subcategory Active

Country

Name

ICN Country name Active

Country

Regulatory

Authority

ICA Country regulatory authority Active

Variable

Name

Variable

Code

Last User Updated Last Changed Date Description Active Flag
Event Code IEC Event code Active

Event

Keywords

IEK Event keywords Active
Event Name IEN Event name Active

Event

Sequences

IER Event sequences Active
Event Type IET Event type Active

Event

Variation

Number

IEV Event variation number Activ

Product

Dosage Form

IPF1 Product dosage form Active

Product

Family Code

IPC Product family code Active

Product

Family Name

IPN Product family name Active
Product Name 1 IP1 Product name 1 Active
Product Name 2 IP2 Product name 2 Active

Sequence

Keywords

ISK Sequence keywords Active

Sequence

Name

ISN Sequence name Active

Sequence

Number/

Code

ISC Sequence number/code Active

Sequence

Status

ISS Sequence status Active
Sequence Status Date ISD

Sequence

status date

Active

Sequence

Submission

Filing Type

ISF

Sequence submission

filing type

Active