Creating Domains and Assigning Dictionaries to Domains

A domain is a logical group of dictionary terms and VTAs. You must explicitly associate a dictionary with a domain in order to use it in that domain. In addition, you can define terms, relations, and verbatim term assignments (VTAs) for use only in a particular domain.

When you use TMS, you usually see a domain view of repository data; that is, you see only data associated with the current domain, including global and domain-specific terms and relations, for the dictionary or dictionaries you have linked to the domain.

TMS domains enable you to use the TMS repository differently in different situations as necessary. For example, you can use domains in the following ways:

• You can tailor dictionary modifications and VTAs for a particular use by defining them as domain-specific. For example, you could create two domains for reference by two studies that needed to track one drug's effect on different body systems.

• You can associate different dictionary combinations with different domains. For example, you might need to reference one adverse event dictionary in one country, and a different one in a different country. Your sites in the two countries can use different TMS domains.

• If you choose, you can allow classifying terms to nonapproved dictionary terms in some domains but not others. For example, in a domain used for an active study you can prevent classification to nonapproved terms, but in a domain used for post-marketing surveillance, you can allow classification to nonapproved terms to prevent unnecessary reclassification after a dictionary upgrade.

This section includes:

• Creating a Domain
  
• Assigning a Dictionary to a Domain
  
• Unassigning a Dictionary from a Domain
  

Creating a Domain

To create a domain:

1. From the Definition menu, select Define Domains to reach the Define Domains window. The Define Domains window has two tabs: Domains displays a single domain and its audit information, and Multi Display Domains displays the names and descriptions of several domains at once.
2. Insert a new record in either tab window, and enter a name and description for the new TMS domain.

   Note:

   Do not use special characters in the Domain Name. Characters such as (& @ *) may cause problems, including preventing using the Disconnected System Integration feature for studies associated with the domain.

3. Save. TMS populates the audit fields.
4. Click the Dictionaries button to reach the Define Domain Dictionaries window. See Assigning a Dictionary to a Domain.

Assigning a Dictionary to a Domain

You must assign a base dictionary to a TMS domain before you can use it (filter dictionaries inherit their domain assignments from their base dictionary). A dictionary may be assigned to more than one domain, and a domain may have more than one dictionary, and any number of non-external terms, assigned to it.

Note:

All dictionaries associated with a single domain must be either base dictionaries or virtual dictionaries with an identical cut-off date and time. Do not use a combination of base and virtual dictionaries or virtual dictionaries with different cut-off dates (including the complete timestamp, down to the second) with a single domain.

In addition, a domain can be associated with only one rendition—base or virtual—of any one base dictionary.

To assign a dictionary to an existing TMS domain:

1. From the Definition menu, select Define Domains to reach the Define Domains window and query for the domain to which you want to assign one or more dictionaries.
2. Click the Dictionaries button to reach the Define Domain Dictionaries window.
3. Click the ellipsis (…) or press F9 to launch the list of values for available dictionaries.
4. Select a dictionary and click OK.
5. Select VTA Appr Reqd? to require that in this dictionary/TMS domain combination, all VTAs are created as Unapproved. There is one exception to this rule: if the VTA has been created via Synchronization because of a direct match to a dictionary term, the VTA is created as approved.

   This may be useful at the beginning stages of a study, or use of the TMS domain, because it gives you the opportunity to manually check TMS's classifications. When you are satisfied that a classification is correct, you can manually approve the VTA in the Approve VTAs window under the Omission Management menu. After you do, TMS classifies all future occurrences of the verbatim term automatically.

   The default setting of the VTA Appr Reqd? flag is determined by the setting of a reference codelist value that appears in the TMS_CONFIGURATION codelist; see DOMVTAAPPRREQD.

   You can change the VTA Appr Reqd? flag setting at any time, including during an ongoing study.

6. Select the Action Appr Reqd? box to require that in this dictionary/TMS domain combination, all Answerable Action assignments must be manually approved. Internal Actions are used for this purpose.

   The default setting of the Action Appr Reqd? flag is determined by the setting of a reference codelist value that appears in the TMS_CONFIGURATION codelist; see DOMACTAPPRREQD.

   You can change the Action Appr Reqd? flag setting at any time, including during an ongoing study.

7. VTI Allowed? Check to make it possible to create Verbatim Term Individual (VTI) classifications. This is required if non-unique terms are allowed. It is possible to select this setting only if VTIs are allowed in the dictionary definition.
8. Autocode with Aux? Check to enable the TMS autoclassification process to create VTIs after the same term with the same auxiliary information has been manually classified. It is possible to select this setting only if it is allowed in the dictionary definition. Changing this setting affects only future executions of Autoclassification.
9. In the Non Appr DT drop-down:

   • Select None to prevent classification to nonapproved dictionary terms.

   • Select VTA to allow classification to nonapproved dictionary terms. This setting may be appropriate, for example:

     • during post-marketing surveillance if you do not want to have to reclassify verbatim terms whose dictionary terms become invalid (nonapproved) after a dictionary upgrade

     • if you are using MedDRA-J and want to be able to classify terms to nonpreferred Japanese terms when multiple Japanese terms correspond to the same English term.

     When you select this option, in this domain the Autoclassification job treats nonapproved terms exactly the same as approved terms in this dictionary.

     Note:

     You can change this value from VTA to None only if no current VTAs are linked to a nonapproved dictionary term in the dictionary/domain combination.

10. To add another dictionary, click in the next row and repeat the process.
11. Click OK. TMS saves the domain/dictionary links you have defined.

Unassigning a Dictionary from a Domain

To unlink a dictionary (to prevent its use in this TMS domain), highlight it and select Record, then Delete.

Note:

You cannot delete a domain/dictionary assignment if a filter dictionary is defined on the base dictionary and contains dictionary terms. Filter dictionaries inherit the domain assignments of their base dictionary. See Filter Dictionaries for more information.