Defining Links Between Dictionaries

You cannot relate terms in separate TMS dictionaries until you establish linkage between the dictionaries. TMS allows you to define the following types of linkage between dictionaries:

  • A cross-dictionary link allows you to define a dictionary named relation between two dictionaries; see Defining Dictionary NRLs. After you create the dictionary named relation, you can create relations between terms in the linked dictionaries.

  • A Translation Derivation Link connects two dictionaries of different languages, enabling you to derive translations between corresponding terms in the dictionaries based on the dictionary code. These links are only permissible between dictionaries with identical structure.

  • Define an Is Filter Dictionary Of link from a filter dictionary to its base dictionary.

  • Define a Has Filter Dictionary link from a base dictionary to its filter dictionary.

For more information, see:

Defining a Cross-Dictionary Link

Using cross-dictionary links can help you migrate a study from one base dictionary to another more easily. It also provides you more flexibility in creating relations in the repository.

Before you can define relations between terms in different dictionaries, you must link the dictionaries using the Dictionary Link tab window. TMS refers to the links you define in this window when it lists the candidate dictionaries for a reference term in the Repository Authoring window. After you select the first term in a relation, TMS restricts the list of candidate dictionaries for the reference term in the relation by using the cross-dictionary links defined for the first term's dictionary.

Note:

Links between dictionaries are bi-directional, so you can define relationships from terms in either dictionary to terms in the other dictionary once you create the link.

After you define the cross-dictionary links you need for a particular dictionary, see Setting Up Cross-Dictionary Relations to define relations between terms in the linked dictionaries.

Rule

You must choose two Active base dictionaries. Term mappings can span dictionary levels, although group and VT levels do not support term mappings.

Creating a Cross-dictionary Link

To create a cross-dictionary link in the TMS user interface:

  1. From the Define Dictionaries window, choose either dictionary in the relation by clicking its name in the structured part of the window.
  2. Click the Dictionary Link tab. The Define Dictionaries window displays the Dictionary Link tab window.
  3. Choose Record, then Insert.
  4. From the Link Type field, choose Cross Dictionary Link.
  5. From the To Dictionary list, choose the dictionary to which you want to link.
  6. Save. If both dictionaries satisfy the linkage criteria listed above, TMS commits this cross-dictionary link to the database.

You can create links from one dictionary to multiple target dictionaries. Select links to other target dictionaries by selecting the next lines and inserting records.

You can break a cross-dictionary link by deleting its row from the Dictionary Link tab window. TMS allows you to remove a cross-dictionary link only if no dictionary named relations have been defined between the linked dictionaries.

Defining a Translation Derivation Link

Translation Derivation Link enable you to connect a global language dictionary (usually one with terms and relations in English) to an identically structured local language dictionary. Once you define the link, the reporting levels of the two dictionaries are linked. You can then automatically derive a translation for a reported level term in either direction: you can determine the global language equivalent of a term in the local language dictionary, or vice versa.

TMS derives a term's translation by searching in the non-coding dictionary for a term on the same level that shares the same dictionary code. Note that TMS still derives values in the coding dictionary by using the hierarchy of that dictionary.

Because TMS cannot derive translations correctly unless each code appears exactly once in each of the linked dictionaries, you should run the Translation Reports to resolve differences between the data in these dictionaries after you link them. See Translation Reports to Identify Inconsistent Data for details.

In this section, you only define the Translation Derivation Link between two dictionaries. During the process of Linking an Oracle Clinical Study to TMS in the TMS Domain Elements window, you identify the global language dictionary and local language dictionary in this pairing, and define which one is the coding dictionary for this Oracle Clinical project or study.

Rules

The dictionaries must satisfy the following criteria:

  • You must select two Active base dictionaries with identical structure. The short names of the dictionary levels must match exactly.

  • The dictionaries must be in different languages. You set a dictionary's language from the Language field in the Base Dictionary tab.

  • Both dictionaries must have a coding level.

  • The linked dictionaries must have dictionary codes that use the same number of bytes to store each digit. Single-byte and multibyte (or "narrow" and "wide") representations of the same characters are not considered equivalent by TMS.

You can only delete Translation Derivation Links when neither of the linked dictionaries contains any data. You also cannot set a dictionary to Provisional status if it has a Translation Derivation Link.

Defining a Translation Derivation Link

To define a Translation Derivation Link:

  1. From the Define Dictionaries window, choose either dictionary in the relation.
  2. Click the Dictionary Link tab. The Define Dictionaries window displays the Dictionary Link tab window.
  3. Choose Record, then Insert.
  4. From the Link Type field, choose Translation Derivation Link.
  5. From the To Dictionary list, choose the dictionary to which you want to link.
  6. Save. If both dictionaries satisfy the linkage criteria listed above, TMS commits this cross-dictionary link to the database.

To delete a Translation Derivation Link, select its row in the Dictionary Link tab window, choose Record, and then Delete. As stated in the Rules above, you cannot delete a Translation Derivation Link if data exists in either of the linked dictionaries.

Defining Filter Dictionary Links

When you define a filter dictionary, you must create a dictionary link between the filter dictionary and its base dictionary. You can define the link in either direction; TMS then displays the link from each dictionary. You must define these links before you can activate the filter dictionary.

Each filter dictionary can have only one base dictionary, and each base dictionary can have only one filter dictionary.

Filter to Base

To create a link from the filter dictionary to its base dictionary, do the following:

  1. With the filter dictionary selected in the Define Dictionaries window, click the Dictionary Link tab. The Dictionary Link tab opens.

  2. From the Link Type list, select Filter Dictionary of.

  3. Click in the To Dictionary field. The Cross Dictionary Link Dictionaries list of values appears.

  4. Select the base dictionary. For the MedDRA SMQ filter dictionary you must select MedDRA as the base dictionary.

  5. Save.

Base to Filter

To create a link from the base dictionary to a filter dictionary, do the following:

  1. With the base dictionary selected in the Define Dictionaries window, click the Dictionary Link tab. The Dictionary Link tab opens.
  2. From the Link Type list, select has Filter Dictionary.
  3. Click in the To Dictionary field. The Cross Dictionary Link Dictionaries list of values appears.
  4. Select the filter dictionary.
  5. Save.