Using the Release Label Authoring Window

You can use the Release Label Authoring window (under the Repository Maintenance menu) to create named relations of type Release Label between dictionary terms.

Release Label named relations allow you to track complex changes to dictionary terms in different versions of the same dictionary such as:

• merging two terms into a single term

• splitting a single term into two terms

• replacing one term with another term

Because these changes involve multiple inserts and deletes in a single audit transaction, TMS cannot automatically maintain a record that these terms are related. You can create relations here.

You can also create relations between terms in different dictionaries in this window.

TMS applies the named relation from the first term listed in the window (in the section that starts with the Domain field) toward the second term listed in the window (in the section that starts with the Ref. Domain field).

This section includes:

• Defining a Release Label Named Relation Between Two Terms
  
• Checking Data Before Activation
  
• Transferring Data
  
• Additional Fields
  

Defining a Release Label Named Relation Between Two Terms

To define a relation between terms using the RL named relationship, complete the following steps:

1. From the Repository Maintenance menu, select Release Label Authoring.
2. Across the top of the screen, select the a value for each of the following:
   • Group. Select the Activation Group to use to activate this new relation.
   • Source. Select either Pre Dictionary Data, Dictionary Data, or All Data. This value determines whether TMS retrieves terms from the predictionary tables, production tables, or both.
   • Named Relation. Select the predefined named relation that you want to apply to the relation you are defining. TMS displays only named relations of type Release Label.

     Note:

     If you select a Release Label that is not linked to a dictionary that is linked to the Activation Group you selected, the list of values in the Dictionary and Ref. Dictionary fields will not contain any values. You must either select a different Release Label or link the Release Label you selected to the dictionary you need; see Defining Dictionary NRLs.

3. The window includes two identical groups of fields, one for the first term in the relation and one for the reference term. TMS applies the named relation from the term in the Domain section toward the term in the Ref. Domain section.
   

   Enter fields in both sections as follows. You can click in most fields to activate the link to the list of values on the right-hand side of the field.

   • Domain. Select the domain associated with the term or select Global if the term is a global term. The list of values is restricted by the Activation Group you selected in the Group field.
   • Dictionary. Select the dictionary that includes the term. The list of values is restricted by the domain you selected and the dictionaries associated with the named relationship you selected. It displays Release Labels and cut-off dates for all dictionary versions.
   • Release Label. The system displays the Release Label of the dictionary/Release Label combination you selected in the Dictionary field. You can select a different Release Label of the same dictionary from the list of values or select NEXT or LATEST:
     • NEXT. Use NEXT when one side of the relationship is in the predictionary table. When you click Transfer Data, the Activation process sets the Release Label to the one it creates for that Activation.

       For example, you can create the RL named relations from MedDRA 7 HLTs "Liver and spleen infections" and "Gallbladder infections" to the MedDRA 8 single term, "Hepatobiliary and spleen infections" before you activate MedDRA, 8 and include the named relations in the same Activation Group as MedDRA 8, specifying NEXT for the MedDRA Release Label. See Release Label Named Relation Example 1 for more information.

     • LATEST. TMS sets the relation timestamp to the latest (current) version of the dictionary.
   • Cut-off Date. The system automatically displays the cut-off date associated with the dictionary Release Label you specify.
   • Level. Select the level of the dictionary that contains the term.
   • Term. Select the term. TMS enters the appropriate subtype for the term in the Term Subtype field.
4. Use the instructions above to enter values that apply to the reference term in the relation in the reference section (beginning with Ref. Domain).
5. Select a Relation Subtype:
   • Company. Available for global terms only. Select Company if the relation is between two company terms or between a company term and an external term.
   • Domain. Select Domain if the relation is between two domain terms or if one of the terms is a domain term.
   • External. Available for global terms only. Select External if the relation is between two external terms.
6. Save. TMS saves the new data with the Activation Group in the predict tables.

Checking Data Before Activation

Click the Check Data button to verify the data. If TMS detects any errors, it displays a notification in the Error Msg field. See Activating Data for more information.

Transferring Data

To transfer the defined relation and any other terms and relations currently in the selected Activation Group from the predictionary tables to the production tables, click the Transfer Data button. See Activating Data for more information.

Additional Fields

The following read-only fields are displayed at the bottom of the window:

• DML: This field displays the DML transaction being performed on the defined relation.

  TMS uses a series of Insert and Delete transactions (collectively known as DML--Data Manipulation Language--transactions) to move data from the predictionary tables to the production tables. Each of these transactions are explained as follows:

  • When a predictionary record is saved, the DML value changes to Insert.

  • After a record is transferred into the production tables, the DML field displays a null value.

  • When a record is deleted from the production tables, a replica of that record gets automatically inserted within the predictionary tables. This replica is created with a DML value of Delete.

• Error Msg: TMS displays a notification in this field if any errors are encountered on your clicking the Check Data button.

• Created By: This field automatically displays the user name of the individual who created the relation. It is populated after the relation is saved the first time.

• Creation: This field automatically displays the date and time the relation was created. It is populated after the relation is saved the first time.

• Deleted By: This field is populated only when a relation is deleted from the production tables and activation/transfer of data is performed after such a deletion. It displays the user name of the individual who deleted the relation.

• Valid Until: This field automatically displays the date and time until which the relation remains valid. It is populated after the relation is saved the first time.