12 Repository Maintenance

Data Currency and Data Source Filters

The top of this window enables you to focus your search in two areas. Use the Data Currency option in the upper left part to view all data or only current data, and you can choose to view preliminary data and/or historical data as well as current data by making a selection in the Data Source list to the upper right. See "Modifying Repository Data in the Maintain Repository Data Window" for more information.

Controlling the Default Approval Status of New Terms

When you create new terms in the Maintain Repository Data and Repository Authoring windows, you can designate them as Approved or Nonapproved by selecting or clearing the Appr? (Approved?) box for that record. The TMS_CONFIGURATION reference codelist setting DTAPPRFLAG controls the default setting of the approved box in each window: if DTAPPRFLAG is set to Y, the default setting for Appr? is checked; if DTAPPRFLAG is set to N, the default setting is unchecked.

For instructions about changing the DTAPPRFLAG setting, see "Other Installation-wide Codelists". You must have the tms_define_priv role to change reference codelist settings.

For more instructions about creating new terms, see:

• "Adding and Deleting Relationships Between Terms" for adding new terms using the Maintain Repository Data window.

• "Creating New Terms" for adding new terms using the Repository Authoring window.

Term and Relation Icons

In the leftmost column on the right side of the screen, TMS displays T and line (_) icons that represent the state of each term and its relation to the current term, respectively. For the current term, which is highlighted in the middle block, TMS displays only the term icon.

TMS indicates that a term has been deleted by displaying a red X in place of the T icon to the left of the term. TMS indicates that a relation has been deleted by displaying a red X in place of the line icon to the left of the term. Visible black T and line icons indicate current terms and relations, respectively.

If one of these icons is not displayed, and there is no red X in its place, the term or relation is in a predict table awaiting Activation.

Current Level and Term

The current level is the level displayed in the Current Level block at the middle of the screen at any given time. You can select the current level by clicking on it in the dictionary hierarchy tree structure, at which point TMS displays the short name of the current level in the Term column in this block. To view data, you must then execute a query in the middle block.

The current term is the term displayed on a blue background in the Current Level block. After a query, TMS makes the first record the current term by default. You can change the current term by selecting another one with your cursor, or by querying for it. TMS displays data on screen as it relates to the current level and term—that is, the upper block displays terms in the level above the current level and related to the current term, and the lower block displays terms in the levels below the current level that are related to the current term.

To move related terms of the current term into the Current Level block, click on the level you want in the tree structure while the current term is displayed on the right, or double-click on the related term.

To see unrelated terms in any level, click on the level you want in the tree structure and then execute a query in the Current Level block.

The Current Level block in the middle of the window is the only one in which you can change the sort order (see "Changing the Sort Order").

Display of Relationships in Strong Dictionaries

In strong dictionaries, the Maintain Repository Data window displays the parent and child relationships for the current term. The parent terms are in the Level Above block: if the current term is related to a reference term in the dictionary level above the current level, this reference term will appear in the Level Above block. If two (or more) levels are related to the current level just above it in the hierarchy, the current level is displayed twice (or more) in the tree structure. The level displayed in the Level Above block depends on which display of the current level you highlight in the tree structure.

Similarly, each row in the Level Below block represents a child term and its relation to the current term. The same rules apply as in the Level Above block: each row represents a relationship from the current term to a child term one level below it in the hierarchy.

Figure 12-1 shows parent and child relationships in the Maintain Repository Data window. In this example, named relations have been suppressed. You can either display or hide (suppress) the display of named relations in the Maintain Repository Data window by changing the setting SUPPRESNAMDRELS in the installation reference codelist TMS_CONFIGURATION. A description of this setting is.

Figure 12-1 Strong Relationships in the Maintain Repository Data Window

In the example in Figure 12-1, the current term "Muscle and tendon injuries" has a parent term of "Injuries NEC" and several child terms including "Tendon rupture" and "Repetitive strain injury."

Display of Named Relations

Because the terms in weak dictionary folders do not necessarily belong to a hierarchy of dictionary levels, the Maintain Repository Data window cannot organize the relationships into parent and child terms. Instead, this window arranges the terms by their use of Indicator and Reciprocal Indicator halves of named relations.

To illustrate the presentation of these relations with an example, assume that a TMS installation contains the named relations in the following table.

In Figure 12-2, the term "California" is currently selected from a weak dictionary folder of geographic place names.

Figure 12-2 Named Relations in the Maintain Repository Data Window

The window organizes relations into two groups:

• In the upper block, TMS displays relations in which the current term is the reference term in the relation. Relations appearing in the upper block always use the Indicator half of a named relation, so you can read them from the upper block downward to the current term. In the geography dictionary example, the relations read "CA – Abbreviation – California" and "United States – Broader Term – California."

• In the lower block, TMS displays relations in which the current term is the first term in the relation. The direction in which you read these relations depends on the type of named relation. One-directional relations such as "California – is a – state" use the Indicator relationship, so you should read these relations from the current block to the lower block. Bi-directional relations that appear in the lower block such as "Los Angeles – Narrower Term – California" use the Reciprocal Indicator relationship, so read these relations from the lower block to the current block.

You can also use the Maintain Repository Data window to view the named relations you define for strong dictionaries. For both parent and child terms, the Maintain Repository Data window shows whether the given relation is linked via a strong or a named relation. If STRONG appears in the Relation field, that row represents a strong relationship; if either an Indicator or Reciprocal Indicator relationship appears, the given terms are linked by a named relation.

Using an Extended Search

Extended Searches enable you to search all domains, dictionaries and levels for a term. You can focus your Extended Searches in the following ways:

• Choose a Search Type. You can use a Cross Search (which searches all domains, dictionaries, and levels), or choose a user-defined search object. See "Defining Search Objects".

• Choose a Data Currency option. You can restrict searches to current data only, or all data (current and expired data).

• Choose a Data Source. You can restrict Extended Searches to pre-dictionary data only, dictionary data only, or the combination of both.

• Enter search criteria about the term. The Extended Search window includes fields for every detail about a term.

To perform an Extended Search, from the Maintain Repository Data window:

1. Click Extended Search, or choose Options, then Extended Search. The Extended Search window opens.

   If you are working on the Verbatim Term Level in the Maintain Repository Data window and you choose a Search Type other than Open Query (see "Defining Search Objects"), TMS populates the Verbatim Term field with the current term from the Maintain Repository Data window and uses it as a filter in the query. You can modify it, but you cannot effectively delete it. The search algorithm must have a verbatim term parameter and it will use the last one entered.

   If you choose a Search Type of Open Search, TMS does not use the value entered in the Verbatim Term field, and the Extended Search window opens in Query mode.

2. If desired, enter your search criteria and execute the query. TMS returns any matches.

3. Choose the term you want. If you click OK, TMS populates the Current Level block of the Maintain Repository Data window with the results of your Extended Search. If you click Cancel, TMS displays the same data in the Maintain Repository Data window as before you executed the search.

Navigating to Data in the Maintain Repository Data Window

Take the following steps to open the Maintain Repository Data window and navigate to the data you want to modify:

Maintaining Terms, Relations, and VTAs

You can add company and domain terms to an external dictionary within its hierarchical structure (company terms and company relations are available to all TMS domains; domain terms and domain relations are available only within the TMS domain in which you define them). You can define strong relations between VTAs, company and domain terms, and external terms (terms supplied in an external dictionary such as MedDRA or WHO-Drug).

You can modify or delete company and domain dictionary terms, and their relations. See "Deleting Terms from a Dictionary" and "Modifying a Term".

Verbatim Term Assignments (VTAs) are represented by their verbatim term and Verbatim Term Individuals (VTIs) are represented by their verbatim term and auxiliary information. VTAs may be available either globally or only in a TMS domain (see "Global and Domain VTAs"), and inherit the global/domain status of their verbatim term. VTIs are available only in a TMS domain (see "Nonunique Coding Level Dictionaries").

When you save your changes, TMS creates a new record in the predict tables for the term or relation to be inserted, updated, or deleted. When you requery you can see both the current record from the production tables and the new record in the predict tables. When you activate data, records that pass Activation move from the predict to the production tables, and the old production records are no longer current. Terms and relations that do not pass Activation remain in the predict tables with an error message.

This section includes general instructions for tasks, followed by detailed information on the fields in each block of the window, as follows:

• Adding and Deleting Relationships Between Terms

• Deleting Terms from a Dictionary

• Adding a Term to a Dictionary Level

• Modifying a Term

• Define Strong Relations to Terms in Other Levels

• Current Level Block Fields

• Upper Block Fields

Resolving High-Level Omissions

When a derivable term is not related to any terms in the next higher derivable level, TMS cannot derive a term from the higher level, and creates a high-level omission.

TMS does not return high-level omissions to the external system as discrepancies. It creates these omissions within TMS and returns values to the external system for all the derivable levels possible. When a high-level omission is resolved in TMS, the missing high-level value is derived to the external system during the next data exchange (Batch Validation in Oracle Clinical).

1. Open the Maintain Repository Data window via the Repository Maintenance menu.

2. Select High Level Oms. TMS displays the High-level Omissions window.

3. Execute a query for the high-level omissions you want to resolve. For each omission TMS displays the verbatim term, its classification level term, and the derivable higher level where there is no related term.

4. Click on the omission you want to resolve.

5. Click OK to return to the Maintain Repository Data window. In the block in the middle of the window, TMS displays the dictionary term that needs a relation to a term on the higher derivable level. If the current term ever had any relations in the higher level, these are displayed in the upper block with the term and/or relation icon shown as deleted (displayed with a red X).

6. Find a higher-level term to which to link the current term. There are two ways to do this:

   • Press F9 to display a list of values for terms in the level above the current term. TMS displays a shortcut menu labeled Terms and Relations. Enter free-form text and wildcards to limit the search. For example, a search on PH% finds terms beginning with ph.

   • Query on any field(s) in the upper block.

7. Select the higher-level term you want to derive.

8. Save.

Structure of the Window

Organizationally, the Repository Authoring window has three sections that follow the creation of a relation between terms (Figure 12-3).

Figure 12-3 The Repository Authoring Window

Description of ''Figure 12-3 The Repository Authoring Window''

There are three sections in the window:

• The Filter block at the top of the window enables you to narrow the parameters of your query.

• The Terms block displays information about one term in the relation. You can view detailed information about one term in the Terms tab window, or view all terms that match your query in the Multi Display Terms tab window.

• The Relations block displays information about the other term in the relation, as well as information about the strong or named relation between the terms. As with the Terms block, you can view detailed information in the Relations tab window, or view less detailed data about all matches by using the Multi Display Relations tab window. In the example shown in Figure 12-3, TMS displays relations in the lower block that contain "Cardiac disorders," the term selected in the upper block.

When you double-click a record in the Relations block, TMS requeries for relations that contain the other term in the selected row. In the example in Figure 12-3, if you double-click the second row shown in the Multi Display Relations block ("Cardiac disorders – STRONG – Congenital cardiac diseases"), TMS displays "Congenital cardiac diseases" in the Terms block, and displays relations that contain that term in the Relations block.

There are four major functions you can perform in the Repository Authoring window: creating (or modifying, or deleting) terms in the Repository, creating (or deleting) relations between terms in the same dictionary, creating (or deleting) relations between terms in different dictionaries, and querying for named relations that failed Activation.

Creating New Terms

Creating new terms using the Repository Authoring window requires the Terms block only. To create a new term using the Repository Authoring window:

1. From the Repository Maintenance menu, select Repository Authoring. The Repository Authoring window opens.

2. From the Filter block at the top of the window:

   • Choose Terms from the Master Query field. You can only modify Repository data when this value is set to Terms. The Relations setting is used to query for relationships that failed Activation; see "Grooming Data that Failed Activation".

   • Choose an Activation Group, Domain, Dictionary and Level in which you want to create the new term.

   • Use the defaults for all other Filter lists.

3. In the Terms block, enter the required information in the fields. The fields in this block correspond to those in the current block of the Maintain Repository Data window.

4. Save. TMS records your new term in the predict tables for the selected dictionary.

   Note:

   You can modify terms in the same manner. Query for the term you want to modify, then change any of the modifiable fields and click Save.

Creating Named Relations Between Terms

The Repository Authoring window enables you to link dictionary terms with any strong or active named relations that have been defined in your TMS installation. If you do not want to use any of the relationships that display in the Relationship field, from the Definition menu, select Define Named Relations to define a new one.

If a relationship already exists between two terms, you cannot change it to a different named relation. Instead, select the relationship in the Relations block, delete it, then create the new one you prefer.

To create a named relation between terms:

1. If the Repository Authoring window is not open, open it now. (From the Repository Maintenance menu, select Repository Authoring.)

2. From the Filter block at the top of the window:

   • Choose Terms from the Master Query field. You can only modify Repository data when this value is set to Terms. The Relations settings is used to query for relationships that failed Activation; see "Grooming Data that Failed Activation".

   • Choose an Activation Group, Domain, Dictionary and Level in which you want to create the new term.

   • In the Level field, you can further focus your search within the selected dictionary by specifying a level in which you want to query, or search across all levels by selecting the blank value at the end of the list (Figure 12-4).

     Figure 12-4 Selecting Blank Value from the Level Field in Repository Authoring

     
     Description of ''Figure 12-4 Selecting Blank Value from the Level Field in Repository Authoring''
     
     

   • Choose a related level in the Rel. Level field if you know the level of the reference term you want to use. If you leave this field blank, TMS enables searches of the entire dictionary for relations from the selected term.

   • Use the defaults for all other filter lists.

3. In the Terms block, query for the term you want to use as the starting point of the relationship. If this term is linked to any terms in the selected reference level, TMS displays these matches in the Relations block. You can view all matches by clicking the Multi Display Relations tab.

4. Click in the bottom block and choose Record, then Insert. TMS creates a new, blank row in the Relations block and displays the Relations Filter at the top of the block. The Relations Filter specifies information about the named relation, including the dictionary in which your desired reference term is stored, the directionality of the relationship, the named relation you want to use, and the level in which the reference term is stored.

5. From the Relations Filter:

   1. Choose a dictionary. This example describes linking terms within the same dictionary; to view the steps required for creating a cross-dictionary link, see the next section, "Setting Up Cross-Dictionary Relations".

   2. Choose a relationship and direction for the relation shown in the Relation fields. If you choose:

      • a uni-directional named relation and choose From in the Direction Filter, TMS populates your selected term on the left side of the Relation. If you choose To for a uni-directional relationship, the selected term appears on the right side.

      • a bi-directional named relation, your selected term appears on the left side in all cases. Making a selection from the Direction Filter in this situation controls whether the Relationship field displays Indicator or Reciprocal Indicator relationships.

   3. Choose a named relation to create between the selected terms.

   4. Decide if you want to use a uni-directional relationship or a bi-directional relationship. Bi-directional relationships contain reciprocal relationships in the reverse direction.

   5. Choose a level to query in the dictionary, or the blank row to query all levels.

6. In the Relations block rows, choose the reference term from the list of values.

7. Save. TMS inserts your new relationship into the pre-dictionary tables.

Defining a Primary Path

You can also use the Repository Authoring window to define Primary Path Links. To define a primary path, make the following changes to the directions above:

1. Choose a source term as described in the previous section.

2. In the Rel. Level filter, choose a group level that contains the levels in your selected derivation path.

3. Query in Multi Display Relations for the terms to which you want to create primary path relations.

4. Select the PL? flag for each term in the derivation path you want, and save.

Deleting Terms

When you delete a term from a dictionary, you also delete all relations from that term to other dictionary terms. Before activating data after deleting a term, you may want to examine pre-dictionary DML statements to reassign the relations before they are deleted.

Further, if you delete a term from a dictionary's classification level (or group level), TMS automatically marks all associated VTAs or VTIs for deletion as well. This deletion applies both to automatically coded VTAs and VTIs and those created by manual classification. The verbatim terms that had mapped to this classification level term will become omissions upon the next Synchronization.

To delete a term and the relations to it from a dictionary, highlight the term and either select Record and Delete, or press Shift+F6, then save. TMS creates a Delete Statement for the term and its relations in the pre-dictionary tables.

Setting Up Cross-Dictionary Relations

TMS enables you to define, maintain, and browse named relations between base dictionaries by using the Repository Authoring window. By using cross-dictionary links, you can migrate a study from one base dictionary to another more easily.

You can only define relations between terms whose dictionaries are linked via a cross-dictionary link. If the terms you want to relate are in dictionaries that are not linked, see "Defining a Cross-Dictionary Link" to create the cross-dictionary link you need. Note that both dictionaries in a cross-dictionary link must be active base dictionaries.

You can only define named relations as cross-dictionary links; strong relationships are allowed only for intra-dictionary relationships. Definition of relationships is the same as for defining named relations within a single dictionary: you can only define one relationship at a time.

Grooming Data that Failed Activation

You can use the Repository Authoring window to examine either the terms or relations have failed Activation. Browse this data by performing the following steps:

1. From the Filter block at the top of the window:

   • Choose either Terms or Relations from the Master Query list. Errors relating to Term Activation are shown in the upper blocks, and those relating to relations in the lower blocks.

   • Choose the Activation Group, domain, and dictionary that you want to query.

   • In the Data Source list, choose Pre-Dictionary Data. Data that fails Activation remains in the pre-dictionary tables.

2. In either a Terms or Relations block, query for data that failed Activation. To query for all terms or all relations that failed in this Activation Group, domain, and dictionary, enter % in the Error Msg field. TMS returns all data for which the Error Msg field is not null.

TMS displays the relations that failed Activation, with the reason for each failure listed in the Error Msg field. In this mode, update is not allowed. You cannot resolve these failed relations, so browse them to determine the problem with the relation before deleting them in this window.

Entering Variables in URL Informative Notes

You can use variables to add information in the text of the URL. For example, if you include the variable %TERM% in a dictionary-wide URL Informative Note, TMS substitutes the term name in the text of the URL. Thus, when you define the dictionary-wide URL Informative Note https://www.google.com/#q=%TERM%, the term rubeola inherits https://www.google.com/#q=rubeola as an Informative Note. You can connect to this URL from the Browse Informative Notes window.

During URL Informative Note definition, TMS restricts the available variables available.

In URLs for either terms or relations, you can include the following variables that map columns in the TMS_DEF_DETAILS table and apply to Informative Notes: DICT_INFO_HDR_ID, LABEL_TEXT, DEF_DETAIL_ID, LABEL_TEXT_UPPER.

For terms, TMS allows you to include the following variables that map to their counterpart columns in the TMS_DICT_CONTENTS table: TERM, TERM_UPPER, CATEGORY, COMMENT_TEXT, DICT_CONTENT_ID, DICT_CONTENT_CODE, DICT_CONTENT_ALT_CODE, and the VALUE_1 through VALUE_4 columns.

For relations, TMS allows the following variables that map to their counterpart columns in the TMS_DICT_RELATIONS tables, or to columns in the TMS_DICT_CONTENTS tables for the terms in the relation. Where _REF follows the term, you can include the same information from the reference term. The list of values includes: TERM (_REF), TERM_UPPER (_REF), DICT_CONTENT_ID (_REF), DICT_CONTENT_CODE (_REF), DICT_CONTENT_ALT_CODE (_REF), TERM_COMMENT_TEXT (_REF), DICT_RELATION_ID, and COMMENT TEXT.

To add a variable to a URL Informative Note:

1. Click in the Value field and enter the basic URL.

2. While the cursor is in the Value field, press F9 or select Edit to see the list of values.

3. Select a variable and click OK. TMS appends %variable% to any text in the Value field.

You can also cut and paste variables in the Value field to create a valid URL.

Overview of Maintenance Wizard Tasks

To launch the Maintenance Wizard:

1. Select the term you want to modify, and click the Maintain Wizard button at the bottom of the Maintain Repository Data window. The Maintain Data window opens, with your term's Name, ID Number, Current Level, and Level Code at the top of the window.

2. Select a function to perform on this term, and click Next.

3. Complete the steps in the appropriate section:

   Move Relation

   Move Term

   Move Term and Copy Relations

   Move and Merge Term

   Merge Term

   Exchange Terms

Data Pending in the Predict Tables

If the changes you elect to make using the Maintenance Wizard either involve terms that are awaiting Activation in the predict tables or would create duplicates of terms that already exist, TMS will prompt you with an error message. Close the Maintenance Wizard and refresh data in the Maintain Repository Data window to determine the problem before you continue.

Move Relation

The Move Relation function enables you to delete one relation between the selected term and a term in a related level and to create a new relation on the same related level. To move a relation:

1. In the first window of Maintain Data, select Move Relation and click Next.

2. Select a level from the Related Level list, highlight the relation you want to remove, and click Next.

3. Query for a new term to which you want to link the selected term, and click Next. TMS summarizes your changes in the Maintain Data window.

4. Click Finish to execute the changes.

Move Term

When you move a term to a new level:

• TMS deletes the term from its original level and deletes all the relations to the deleted term, with the following exception: TMS does not delete an original relation when the relation to the new level is still valid—for example, when the term has moved between levels of a group. In this case, the relation moves with the term.

  For example, in a drug dictionary the classification level is a group level with two sublevels, Preferred Name and Synonym. You move Synonym A to the Preferred Name level, using the Move Term function. Verbatim Term A, which had been a child of Synonym A, becomes a child of the new term Preferred Name A.

  Caution:

  When you move a term to a new level, all its old relations are deleted (unless the relation is a VTA and you are moving the term from one sublevel of a classification group to another). If its old relations were optional, the new term and relations will be activated and you may lose relations that you need. If the old relations were mandatory, the new terms and relations cannot be activated unless you create current relations.

  You can use the Activation Check mode to see whether Activation will work without actually activating the new terms and relations. You may want to set up an Activation Group just for this purpose. See "Activating Data" and "Creating a New Activation Group".

TMS validates the new term and relations during Activation. To undo the moving of a term before Activation, see "Undoing a Change Before Activation".

To move a term:

1. In the Maintain Data window, select Move Term and click Next.

2. Select the Related Level to which you want to move the selected term, from the list.

3. If you want TMS to delete all VTAs that would be orphaned as part of moving this term, select the Delete VTAs when Mapped box. TMS does not delete any VTAs whose relations are preserved.

   If you choose not to select this box, you must manually reassign VTAs before performing Activation. Click Next.

4. TMS summarizes the changes. Click Finish to execute the move.

Move Term and Copy Relations

The Move Term and Copy Relations function expands upon the Move Term functionality by enabling the moved term to inherit all of the relationships of one of its parent terms. For dictionaries with group coding levels such as the MedDRA primary path dictionary, this inheritance is important because it ensures that you do not have to re-create the relationships for every term you move.

1. Select Move Term and Copy Relations from the Maintain Data window, and click Next.

2. Select a Related Level from the list.

3. If you want TMS to delete all VTAs that would be orphaned as part of moving this term, select the Delete VTAs when Mapped box. TMS does not delete any VTAs whose relations are preserved.

   If you choose not to select this box, you must manually reassign VTAs before performing Activation. Click Next.

4. TMS summarizes your selections in the final window. Click Finish to execute your changes.

Move and Merge Term

The Move and Merge Term command:

• Moves a term to a related level, and

• Merges all relations of the moved term to a different term on the same level

For example, if you move the MedDRA High Level Term HLT1 up to the High Level Group Term level, the Move and Merge Term function enables you to move all relations of HLT1 to another term on the High Level Term level.

To perform the Move and Merge Term function:

1. Select Move and Merge Term from the Maintain Data window, and click Next.

2. Select a Related Level from the list.

3. Query and select the term to which you want to merge the relations, and click Next.

4. TMS summarizes your selections in the final window. Click Finish to execute your changes.

Merge Term

The Merge Term function enables you to delete a term and merge all of the deleted term's relations to a different term on the same level. When you perform the Merge Term function, TMS deletes your selected term; you select the term to which you want to merge relations from the Maintenance Wizard.

To perform the Merge Term function:

1. Select Merge Term from the Maintain Data window, and click Next.

2. Query and select the term to which you want to merge relations, and click Next.

3. TMS summarizes your selections in the final window. Click Finish to execute your changes.

Exchange Terms

When you use the Exchange Terms function, TMS moves the parent term to its child level and creates relations with all its former child's related terms, while moving the child term to its parent level and creating relations with all its former parent's related terms. In other words, TMS exchanges the two terms while maintaining the same relations in related levels.

TMS validates the new term and relations during Activation. To undo the moving of a term before Activation, see "Undoing a Change Before Activation".

To exchange terms:

1. Select Exchange Terms from the Maintain Data window, and click Next.

2. Select the level with which you want to exchange a term. TMS populates the list with applicable terms.

3. Select the term that you want to exchange with the selected term, and click Next.

4. TMS summarizes your selections in the final window. Click Finish to execute your changes.

Undoing a Change Before Activation

To undo a change made in the Maintenance Wizard, manually delete all affected terms in the predict table.

1. In the Maintain Repository Data window, select the same Activation Group you selected when you originally made the change.

2. For each term:

   1. In the middle block, query for the term in its new level. It will have an entry in the DML column.

   2. Highlight the term and delete it, using Record, and then Delete.

3. For each relation:

   1. In the upper block, query for the relation by querying for the higher-level term.

   2. Highlight the term and delete it, using Record, and then Delete.

Browsing Dictionary Loading Error Logs

To browse the contents of a Dictionary Loading Error Log:

1. From the Repository Maintenance menu, select Maintain Dictionary Loading Error Logs. The window opens with the upper part in Query mode.

2. In the upper part of the window, query for the log you want to examine. You can query by Error Log ID, the User ID of the TMS user who loaded the dictionary, or the time and date that the dictionary was loaded.

3. Click in the row for the error log you want to examine. Error details are displayed in the lower part of the window.

Deleting Dictionary Loading Error Logs

You can also delete specific error logs by clicking in the log's row and selecting Record, then Delete, or delete all Dictionary Loading Error Logs by clicking the Delete All button at the bottom of the window.

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.

   
   Description of the illustration ''rel_label_authoring.gif''
   
   

   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.

Preliminary Repository Report

In an Activation process, some terms and relations in the predictionary data fail activation or are not validated. The Preliminary Repository Report lists these terms and relations within a specified Activation Group. Specify the Activation Data Scope to view a set of predictionary data. To run this report, you must have maintenance privileges. The Preliminary Repository Report displays the following:

• Errors Only: These are terms and relations that have failed activation or have not been validated via the Check option in the Activation process. The Errors list also includes terms and relations associated with Informative Notes that have not been activated and validated.

• All: A list of terms and relations that have add, delete or update (DML) statements against them but do not get activated. Also, those terms and relations associated with Informative Notes that have DML statements but remain unactivated, are listed.

The Preliminary Repository Report displays data in four sections.

• Pre-dictionary Contents: Displays term names sorted by Activation Group, Domain, Dictionary and Dictionary level. For each term, the report also lists DML statements and error message.

• Pre-dictionary Relations: Displays relations sorted by Activation Group, Domain, Dictionary and Dictionary level. The report lists the source term and the reference term with their respective dictionary levels, the DML statement for the relation and the error message.

• Dictionary Contents with Pre-dictionary Informative notes: Displays content similar to that in the Pre-dictionary Contents section.

• Dictionary Relations with Pre-dictionary Informative Notes: Displays content similar to that in the Pre-dictionary Relations section.

The Preliminary Repository Report does not describe the Informative Notes in detail. To view the Notes, select the term or relation in the Repository Authoring window. Click on Informative Notes. The Maintain Informative Notes window displays information for the selected term.

To generate a Preliminary Repository Report:

1. Select Repository maintenance in the navigator window.

2. Select Preliminary Repository Report.

3. Fill in the general report specifications. See "Setting Parameters."

4. Enter a value for Job Specific parameters:

   • Activation Group: Select an Activation Group from the list.

   • Activation Data Scope: Select the kind of data to be returned. The options are All and Errors Only.

   • Template: Select the template you want to use for this report. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default template.

5. Submit the job. See "Running a Job."

Dictionary Version and Release Information Report

TMS creates a new dictionary version each time you do one or more of the following and run Activation:

• add, modify, or delete a dictionary term

• modify a dictionary relation

• modify a cross-dictionary relation

• modify a dictionary term Informative Note

For example, suppose your current dictionary version is MedDRA 9. When you add a new dictionary term and run Activation for the first time, a new build of the dictionary is created (build =1) and now the dictionary version is MedDRA 9.1.

The Dictionary Version and Release Information Report tracks dictionary versions. The unique identifier for each version is the date and time stamp. If you have associated a virtual dictionary with your dictionary version, then it is also listed.

The Dictionary Version and Release Information Report displays the following data:

• Release Labels with cut-off dates

• Virtual Dictionaries, if any

The report identifies the name of the active dictionary that it was run for. It then lists the following information in a row:

• Dictionary Name: The full name of the active dictionary.

• Dictionary Short Name: The short name of the active dictionary as entered in the Define Dictionaries form.

• Release Label Prefix: This is the label prefix of the dictionary as entered in the Define Dictionaries form. See "Defining a Dictionary".

  For each build of the active dictionary, the report gives the following information:

• Release Label: This column shows the Release Label of the dictionary version.

• Cut-off Date: This column lists the cut-off date and time for each release.

• Virtual Dictionary Information: In these columns you can see information related to any virtual dictionaries associated with the release.

  • Dictionary Name: This is the virtual dictionary name.

  • Short Name: This is the short name for the virtual dictionary as entered in the Define Dictionaries form.

To generate a Dictionary Version and Release Information Report:

1. Select the Dictionary Version and Release Information Report from the Repository Maintenance menu.

2. Fill in the general report specifications. See "Setting Parameters."

3. Enter a value for each Job Specific parameter:

   • Active Dictionaries: Select the dictionary for which you want to run this report.

   • Template: Select the template for the report. If your company has created a custom template, it appears in the list of values. The Oracle template is the default.

4. Submit the job. See "Running a Job."

Inconsistent Dictionary Codes Report

This report compares terms in the two dictionaries that share the same dictionary code. There should be a one-to-one relationship between the code values in these dictionaries, and the terms should reside in the same domain (whether or not the terms are global) and dictionary level. The Inconsistent Dictionary Codes Report thus generates a list of terms in each dictionary whose dictionary codes:

• exist in one dictionary but not the other.

• match, but reside in different domains or levels.

To run the Inconsistent Dictionary Codes Report:

1. Select Inconsistent Dictionary Codes from the Translation Reports menu.

2. Fill in the general report specifications. See "Setting Parameters."

3. Enter a value for each Job Specific parameter:

4. • Translation Dictionary

   • Second Translation Dictionary

   A Translation Derivation Link must exist between these dictionaries for the report to run correctly.

5. Submit the job. See "Running a Job."

Duplicate and Null Dictionary Codes Report

For Translation Derivation to work correctly, dictionary codes should be unique within a dictionary. The Duplicate and Null Dictionary Codes Report examines all of the dictionary content codes in one dictionary, and outputs term information where terms share the same code. If two or more terms have null codes, the report includes those terms in the report as well. For each duplicate dictionary code, the report flags the code, its Dictionary Level, its Domain, and the number of times it appears in the dictionary.

To run the Duplicate and Null Dictionary Codes Report:

1. From the Translation Reports menu, select Duplicate and Null Dictionary Codes.

2. Fill in the general report specifications. See "Setting Parameters."

3. Enter a value for each Job Specific parameter:

   • Translation Dictionary

   • Template

4. Submit the job. See "Running a Job."

Inconsistent Dictionary Relations Report

Because TMS uses the dictionary hierarchies when deriving translation values, it is important that relations in these dictionaries match exactly. The Inconsistent Dictionary Relations Report shows relations to a term in one dictionary that are different than a relation to the same term in the linked dictionary. The report only considers relations between dictionary terms; VTAs are not included.

Any of the following qualifies two relations as inconsistent:

• The terms in the relation are not the same.

• The relations are in different domains.

• The terms in the relation are the same in both dictionaries, but terms with the same dictionary code reside on different levels in the two dictionaries.

• The relation types are different.

For both dictionaries, the report lists each inconsistent relation's Domain and Relation Type, and the Code, Level, and Term Name for the terms involved.

To run the Inconsistent Dictionary Relations Report:

1. From the Translation Reports menu, select Inconsistent Dictionary Relations.

2. Fill in the general report specifications. See "Setting Parameters."

3. Enter a value for each Job Specific parameter:

4. • Translation Dictionary

   • Second Translation Dictionary

   A Translation Derivation Link must exist between these dictionaries for the report to run correctly.

5. Submit the job. See "Running a Job."