Linking an Oracle Clinical Study to TMS

In TMS, you access dictionaries through a domain. Many domains can have access to the same dictionary. Each domain can have a different combination of dictionaries, different classifications, different company terms, and different rules; see Creating Domains and Assigning Dictionaries to Domains. You can specify a virtual dictionary—a dictionary at a specified point in time—for a domain; see Virtual Dictionaries.

In Oracle Clinical, you must define a TMS Domain Element. A TMS domain element specifies a TMS dictionary/domain combination and links that combination to an Oracle Clinical project or study. You must define a domain element for each dictionary/TMS domain combination used by a particular study or project.

If all studies within a project use the same TMS domain for a particular dictionary, you can assign a domain element to the whole project. If a project's studies use different TMS domains for a particular dictionary, you must assign a domain element to each study separately.

You can assign a domain element for one dictionary to the project, and domain elements for other dictionaries to the project's studies individually.

You can link a single study to more than one TMS domain and/or more than one TMS dictionary. For example, the following is a valid configuration:

• Study A—Domain A—Dictionary A

• Study A—Domain A—Dictionary B

• Study A—Domain B—Dictionary C

In addition, you can change the rendition of a particular TMS dictionary you are using for a study. For example, if you are coding against a MedDRA base dictionary, you can switch to any virtual dictionary that uses the same base dictionary. Using a virtual dictionary for coding enables you to continue using the same terms and relations even as the base dictionary in your installation upon which it is based is modified or updated.

Translation Derivation

If you have set up two versions of the same dictionary, each using a different language, you can derive a dictionary term from one and the corresponding translated term (with the same dictionary code) from the other dictionary. The dictionaries you use must both be active, and have exactly the same structure, including the same level short names.

To do this, you define TMS domain elements that reference two domain/dictionary combinations: one for each language. In the domain element definition, you must call one dictionary the "Global Language" dictionary and the other the "Local Language" dictionary. Your choice for Global Language Dictionary must match the dictionary specified in question sets used in the study or project.

If you are not setting up translation derivation, enter a Global dictionary and domain only. Leave the Local dictionary and domain information blank.

Rules

The dictionaries you choose must satisfy these criteria:

• Before you establish translation derivation for a TMS domain element, you must link the dictionaries you plan to use. See Defining a Translation Derivation Link.

• You can choose two base dictionaries or two virtual dictionaries in a TMS domain element, but not one of each.

• You can choose either the global or local dictionary as the coding dictionary. TMS will derive the translation values from the non-coding dictionary, and rederive these values if they change.

For more information, see:

• Linking a Project with a TMS Dictionary and Domain
  
• Linking a Study to a TMS Dictionary and Domain
  
• Using a New Version of a Dictionary for an Ongoing Study
  

Linking a Project with a TMS Dictionary and Domain

To link a project with a Global Language TMS dictionary and domain, and if necessary, a Local Language TMS dictionary and domain:

1. In Oracle Clinical, from the Plan menu, select TMS Domains.
2. Highlight the project code you want.
3. Click the TMS Domain Elements button.
4. Under the Global heading:

   • Select the short name of the Global Language TMS dictionary from the list of values.

   • Select the name of the Global Language TMS domain from the list of values.

5. Save.

If you need to use more than one dictionary or TMS domain in this project, define additional domain elements on the following lines.

Note:

You can delete a domain element for a project only if there are no classifications or omissions associated with it.

Linking a Study to a TMS Dictionary and Domain

To link a study with a Global Language TMS dictionary and domain, and if necessary, a Local Language TMS dictionary and domain:

1. In Oracle Clinical, from the Plan menu, select TMS Domains.
2. Highlight the project containing the study you want.
3. Click the Studies button.
4. Highlight the study you want and click the TMS Domain Elements button.
5. Under the Global heading:

   • Select the short name of the Global Language TMS dictionary from the list of values.

   • Select the name of the Global Language TMS domain from the list of values.

6. If you are not setting up translation derivation for this study at this site, skip this step.

   Under the Local heading:

   • Select the short name of the Local Language TMS dictionary from the list of values, which includes only dictionaries that have Translation Derivation Links to your selected Global Language Dictionary.

   • Select the short name of the Local Language TMS domain from the list of values.

7. To use the Global Language domain/dictionary combination as the coding dictionary for this study at this site, or if you are not setting up translation derivation, leave the Coding Dictionary? box selected. If you prefer to use the Local dictionary/domain combination as the coding dictionary, clear this box.
8. Save.

If you need to use more than one dictionary or TMS domain in this study, define additional domain elements on the following lines.

You can also remove a TMS domain element from a study by deleting its row from the TMS Domain Elements for Studies window. When you remove its domain element, the study inherits the domain element for the same dictionary assigned to its project.

Note:

You can delete a domain element for a study only if there are no classifications or omissions associated with it.

Force Rederivation

The Force Rederivation button invokes a job that tags all records (parent question responses) in the study associated with the selected dictionary for rederivation during the next Batch Validation job. Normally the batch validation job processes only records that are new or changed. Use the Force Rederivation job when you have made structural changes related to TMS in an ongoing study, including:

• Adding derived questions to a question set; see Adding Derived Questions to an Ongoing Study

• Using a new dictionary version that has a different level structure from the old version; see Upgrading to a New Dictionary Version with a New Structure

• Changing settings in the TMS_CONFIGURATION reference codelist, including CREATEGLOBALVTA, GLOVTAAPPRREQD, DOMVTAAPPRREQD, NONAPPRVTAUSED, ALLOWGLOVTAS, and AUTOGLOVTAS; see Changing TMS_CONFIGURATION Settings After Data Has Been Processed

Using a New Version of a Dictionary for an Ongoing Study

After you link a project or study to an external dictionary, the dictionary vendor may issue a new version of the dictionary; see Upgrading to a New Dictionary Version for information on TMS upgrade features.

In this section:

• Upgrading to a New Dictionary Version with the Same Structure
  
• Upgrading to a New Dictionary Version with a New Structure
  

Upgrading to a New Dictionary Version with the Same Structure

If the new dictionary version does not involve any changes to the dictionary's structure, you do not need to make any changes to your project or study definitions in Oracle Clinical.

Upgrading to a New Dictionary Version with a New Structure

If the new version does include changes to the dictionary structure-such as adding or removing a level, changing a level's name, or changing the relations between the levels-and you want to use the new version in an ongoing study, you must redefine the new dictionary version as if it were a different dictionary (see Defining and Loading Dictionaries), relink your project or study, and redefine the questions and question sets used.

After you complete these steps, the Autoclassification process uses the new dictionary when trying to classify verbatim terms.

1. Before you begin the dictionary upgrade for a study, ensure the following:

   1. Batch Validation has been executed and no new data is being entered into the study.

   2. All open "TMS IN PROGRESS" discrepancies are closed.

2. For each question set used in each study, define a new question set referencing the dictionary version with the new structure.

3. For each parent and derived question used in each study, create a new question. Add a question set referencing the new dictionary version to each parent question and associate new derived questions with the question set variables.

4. Create a new TMS Domain Element with the new dictionary version.

5. Add each new question to the same study question group(s) as the question it is replacing.

6. For the old questions, deselect Collect in Subset. For new questions, select Collect in Study and Collect in Subset. If you want the question to be displayed in data entry screens, select Displayed as well.

7. Edit the DCM layout and move the layout to production.

8. Query existing responses from the OLD TMS parent question and spool a Batch Data Load (BDL) file which references the NEW parent question. For information on how to spool a BDL file, see Doc ID 2607190.1 on My Oracle Support.

   Once the BDL file is loaded, the new TMS Parent question is populated with the old value.

9. From the TMS Domain Elements window, select the study, navigate to the TMS Domain Elements for Study window, and click Force Rederivation.

10. Run Batch Validation for the study.