Defining Informative Note Attributes

This section describes the following topics relating to Informative Notes and Informative Note Attributes:

• Overview of Informative Notes and Attributes
  
• Defining an Informative Note Attribute
  

Overview of Informative Notes and Attributes

Informative notes are data structures that you can create to provide more information about a term, relation, VTA, VTI, or dictionary in the database. The advantage that Informative Notes offer over the other detail items—the code, alternate code, category, and the value_1 through value_4 columns—is their flexibility. Using Informative Notes, you can attach a URL, text in a Character Large Object (CLOB), or a note of predefined length containing character, number, mixed, or date data.

Each time you create an Informative Note, you must base it upon an Informative Note Attribute, which gives the note its type, data type, maximum length, and other properties. Using attributes as the basis for Informative Notes saves time during note definition and provides more consistency among the Informative Notes defined in your database.

You can define dictionary-wide Informative Notes that are inherited by all terms in a dictionary. Users can create an Informative Note for a specific term, relation, VTA/VTI, action assignment, or an SMQ algorithm in a filter dictionary such as MedDRA SMQs. See:

• Defining Dictionary-wide Informative Notes

• Creating Informative Notes for Terms and Relations

• Using the Status/Notes Pop-up Window for creating Informative Notes for VTAs, VTIs, and Action Assignments

• Defining Informative Notes for SMQ Algorithms.

Defining an Informative Note Attribute

This section includes:

• Defining Informative Note Attribute Properties
  
• Defining the Details for the Informative Note Attribute
  
• Making Informative Note Attributes Available for Dictionaries and Record Types
  

Defining Informative Note Attribute Properties

Launch the Define Informative Note Attributes window by navigating to Definition, then Define Informative Note Attributes. The Define Informative Note Attributes window opens, with the Informative Note Attributes tab selected. This tab shows detailed information about one Informative Note Attribute, and is the window for defining new attributes. Click the Multi Display Informative Note Attributes tab to view several attribute records at once.

The Properties block contains the essential information about the attribute: its name, type, and other settings that control its use in TMS.

To define the attribute's properties, from either tab of the Define Informative Note Attributes window:

1. In the Label field, enter text to describe the sort of information you store in Informative Notes based on this attribute. Users defining an informative note for a particular object use the label to choose an informative note attribute on which to base the note.The label text appears as a header wherever the Informative Note appears in TMS.
2. From the Type list, select:
   • Standard. For Informative Notes that contain text, a number, or date, to provide supplementary information about a term, relation, VTA, VTI, or dictionary.
   • URL. For Informative Notes that are character strings representing URLs.
   • Workflow. For Informative Notes used in workflow processes, such as approval of VTAs. If you are creating an Informative Note during classification, VTA approval, or reclassification, TMS requires that you base the note on an attribute of type Workflow.
   • Algorithm. For use with filter dictionaries such as MedDRA SMQs. See Defining Informative Notes for SMQ Algorithms for more information.
3. The Derivable list choice determines whether external systems will be able to derive Informative Notes that you define based on this attribute. Choose Yes to enable external systems to derive this Informative Note data, or No to prevent this derivation.
4. Select the Updateable? box if you want users to be able to update Informative Notes based on this attribute.
5. Select the LOV Validation box if you want TMS to limit the values for a particular Informative Note to those defined in the SQL statement you enter in the LOV Statement field in the Details panel below. This setting is not applicable if no LOV is generated from the LOV statement, and is not relevant for Informative Note Attributes of data type Memo or of attribute type URL.
6. From the Data Type list, choose one of the four available Informative Note data types: Char (character), Date, Memo (for character large objects or CLOBs up to 32K), or Number.

   Attribute types Algorithm and URL should always have a data type of Char.

   You can use the Memo data type for either STANDARD or WORKFLOW Informative Note types.

7. In the Entry Length field, enter a maximum length for Informative Notes based on this attribute. Entry length is irrelevant for Informative Notes of data type Memo or Date. If you do not enter a value in this field for a Char or Number Informative Note, TMS supplies the default value of 300 characters.
8. Save.

Defining the Details for the Informative Note Attribute

Attribute details are optional, but you can create a more specific and useful Informative Note Attribute by specifying them for some applications.

To define attribute details:

1. Navigate to the Details block on the Informative Note Attributes tab to enter attribute details.
2. In the Attribute Code field, enter a mixed-case code to use to link this Informative Note Attribute to an attribute defined in a vendor's dictionary.
3. In the Short Name field, you can enter a unique value for the short name of this Informative Note Attribute. TMS allows short names containing up to ten bytes of alphanumeric text. If you leave this field blank and save the record, TMS supplies a default, unique value.
4. In the Description field, you can enter user-defined text about this Informative Note Attribute.
5. In the LOV Statement field, you can enter the SQL statement you want to use to populate a list of values for Informative Notes based on this attribute. The system limits values to those in the LOV only if you select the LOV Validation? box, described in the above section, Defining Informative Note Attribute Properties.
6. Save. TMS commits this Informative Note Attribute to the database, which enables you to create Informative Notes based on this attribute.

Making Informative Note Attributes Available for Dictionaries and Record Types

Specify the dictionary or dictionaries with which an Informative Note is appropriate for use, and the item—term, relation, term history, dictionary, or filter dictionary algorithm—with which it is appropriate. When users define Informative Notes, the system allows them to select only Informative Note Attributes that you define as appropriate in this window.

1. From the Define Informative Note Attributes window, with the Informative Note attribute displayed (or, in the multi-display tab, selected), click Dictionary Attrs. The Define Dictionary Informative Note Attributes Dictionary (APPROVAL) window opens.
2. Click in the topmost empty row. The fields in the row become enterable. If you need more rows than are displayed, select Insert from the Record menu.
3. In the Base/Filter Dictionary From column, click the ellipsis (…) to display the list of values, which includes all base and filter dictionaries defined. Select a dictionary in which you want to be able to use the selected Informative Note attribute.

   If the Informative Note attribute is of type Algorithm, TMS displays only active filter dictionaries.

4. In the Base/Filter Dictionary To column, click the ellipsis (…) to display the list of values, which includes all base and filter dictionaries defined.

   • In most cases, select the same dictionary you selected in the Base/Filter Dictionary From column. If the Informative Note attribute is of type Algorithm, you must select the same dictionary you selected in the Base/Filter Dictionary From column.

   • To use the attribute for cross-dictionary relations, select the reference dictionary. You can select a different dictionary only if there is a cross-dictionary link or a filter dictionary link defined for the two dictionaries and only if Applies To is set to Relation (see next step); see Defining a Cross-Dictionary Link and Defining Filter Dictionary Links.

5. In the Applies To column, select the type of item for which the user can create Informative Notes from this attribute in this dictionary or dictionary combination.

   Note:

   If an attribute is appropriate for use with more than one item, create a record (add a line) for each one.

   • Content. If an attribute is appropriate for use in creating an Informative Note on a term, select Content. If the Informative Note attribute is of type Algorithm, you must select Content.

   • Relation. If an attribute is appropriate for use in creating an Informative Note for a relation between terms, including terms in different dictionaries, select Relation.

   • Term History. If an attribute is appropriate for applying to term history data; for example, to comment on a change in term status; select Term History. See Term Statuses for more information.

     Only Informative Note attributes of type Workflow and data type Memo can be used for term history Informative Notes.

   • Dictionary. If an attribute is appropriate for use in creating a dictionary-wide Informative Note, select Dictionary.

6. In the Status column, leave Active selected.

   Change to Retired later, to prevent any further Informative Notes from being created in this dictionary or dictionary combination with this Informative Note attribute.

7. Save.