The Oracle Thesaurus Management System (TMS) VTA Maintenance menu, available if you have the tms_reclassify_priv role, provides access to windows that you can use to manipulate verbatim term assignments (VTAs) and verbatim term individuals (VTIs) in TMS. Users with tms_classify_priv can also access the Reclassify Indication Assignments window.
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A Verbatim Term Assignment, or VTA, is the mapping between a verbatim term and the dictionary term to which it is classified. VTAs may be available globally or in one or more TMS domains (see "Global and Domain VTAs") and they may or may not require manual approval. In the Promote/Demote VTAs window you can change a VTA's status from Global to Domain or from Domain to Global. You change a VTA's approval status in the Approve VTAs window under the Omission Management menu option. See "Approving and Unapproving VTAs" for more information.
Default settings for Approved/Nonapproved and Global/Domain statuses for VTAs are set the in the reference codelist TMS_CONFIGURATION. You can override the default approval status for a particular dictionary/domain combination; from the Definition menu, select Define Domains, then Dictionaries. You can override the default for a particular VTA in the Classify VT Omissions window for both types of status. Changing a VTA's status in the Promote/Demote VTAs window overrides all previous settings.
TMS displays VTAs in all dictionaries and all TMS domains together. TMS displays Global VTAs first, in alphabetical order, then Domain VTAs grouped by domain, with domains listed alphabetically. VTAs are displayed in alphabetical order within their domain.
If a verbatim term is classified to different dictionary terms in two or more different TMS domains, it is listed twice or more, once for each VTA. In the text block, the verbatim term is listed with information about the VTA.
A Domain VTA is available only in the TMS domain(s) in which it was created. A Global VTA is available across all TMS domains. Domain VTAs take precedence over Global VTAs; if a Domain VTA and a Global VTA exist for the same verbatim term within a domain, TMS uses the Domain VTA.
Note:
Even if the current domain allows classifying terms to nonapproved dictionary terms (for example, dictionary terms that are no longer valid in the current dictionary version), VTAs linked to nonapproved dictionary terms are not displayed in this window because they cannot be promoted. TMS does not allow global VTAs to be linked to nonapproved dictionary terms.When you promote a Domain VTA to global status, TMS makes the newly promoted Global VTA available to all TMS domains. Thus, after you promote a Domain VTA that maps the source term "pain in right foot" to the dictionary term "foot pain NOS", all domains in that instance that do not already have Domain VTAs defined for the source term "pain in right foot" will classify that source term according to the Global VTA.
However, domains might already have Domain VTAs defined to classify this source term. Because these Domain VTAs override the classification specified in the Global VTA, there are two possible outcomes in base dictionaries:
If the Domain VTA's mapping differs from that defined in the Global VTA, TMS retains the Domain VTA. To use the same example, if a Domain VTA specifies that "pain in right foot" should classify to the more specific dictionary term "right foot pain," TMS will keep that Domain VTA, and studies using that domain will continue to map that source term in the same way.
On the other hand, if the Domain VTA is exactly the same as the newly promoted Global VTA, there isn't anything for the Domain VTA to override; both global and domain behavior are the same. In this case, TMS removes the Domain VTA, and in this domain, TMS classifies this source term according to the Global VTA. You can promote a Domain VTA to a Global VTA to make it available in all TMS domains.
The outcome is different for Domain VTAs in virtual dictionaries. If a Domain VTA exists in a virtual dictionary, and it maps to the same dictionary term as a newly promoted Global VTA, TMS retains the Domain VTA.
When you demote a Global VTA to a Domain VTA, you must specify in which TMS domains you want TMS to create a Domain VTA. If you specify a TMS domain that already has a Domain VTA for that term, TMS will not override the Domain VTA already created. If you do not specify a domain that used the Global VTA, TMS creates an omission during the next Batch Validation. You will be able to create a Domain VTA for it during classification.
When you demote a Global VTA to a Domain VTA, TMS treats it as a new VTA and assigns approval status to it according to setting of the Approval Required? box in the Define Domain Dictionaries window for the relevant domain.
When you promote a Domain VTA to a Global VTA, TMS assigns it the approval status indicated in the GLOVTAAPPRREQD reference codelist (see "GLOVTAAPPRREQD" for more information.
All Informative Notes associated with a VTA expire when you promote or demote the VTA. For more information on creating Informative Notes for VTAs, see "Using the Status/Notes Pop-up Window".
To promote a Domain VTA to a Global VTA:
From the VTA Maintenance menu, select Promote/Demote VTAs to reach the Promote/Demote VTAs window.
Query for the VTAs you want.
Highlight the VTA you want to promote.
Click Promote to Global VTA.
(Optional) You can type a comment about this VTA promotion in the Comment field, which is at the bottom of the window. You can then audit these changes in the Browse Repository Data window; click Browse Dictionary to reach this window directly from Promote/Demote VTAs.
Save.
To demote a Global VTA to a Domain VTA:
From the VTA Maintenance menu, select Promote/Demote VTAs to reach the Promote/Demote VTAs window.
Query for the VTAs you want.
Highlight the VTA you want to demote.
Click Demote to Domain VTA.
Highlight the domain(s) in which you want the VTA to be available.
Note:
You can select more than one record using the standard Windows Shift+Click and Ctrl+Click behavior.(Optional) You can type a comment about this VTA demotion in the Comment field, which is at the bottom of the window. You can then audit these changes in the Browse Repository Data window; click Browse Dictionary to reach this window directly from Promote/Demote VTAs.
Save.
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You can use actions to communicate with an external source data system or internally in TMS about a term by assigning an Action to the term; see "Defining and Using Actions". When a verbatim term enters TMS that requires an Action, you can assign the Action in the Classify VT Omissions window in the Omission Management menu; see "Apply an Action to a Term" for more information.
If Action assignment approval is required in a particular dictionary/domain combination, you can approve Action assignments in the Approve Action Assignments window. Upon approval, TMS automatically sends the base Answerable Action to the external system; see "Approving Action Assignments" for more information.
Users with TMS_APPROVE_PRIV and TMS_RECLASSIFY privileges can create, modify, and delete Action assignments in this window. Users with TMS_CLASSIFY_PRIV can query in this window. They can also update or delete Action assignments they created, within the time period set by the reference codelist value MTACTHOUR. If this value is set to zero (0) they cannot perform any operations in this window.
In the Maintain Action Assignments window you can do the following:
You can proactively assign actions to verbatim terms that have not yet entered the system. If you think a term is likely to be passed to TMS from the external system, you can create a verbatim term and assign an Action to it here. TMS then applies the Action to the term when it does occur in the current dictionary/domain combination. By assigning actions to terms early in a study, you can reduce the number of omissions that must be manually processed.
View all the Action assignments in the system, one dictionary/domain combination at a time, including current and past Action assignments.
Reject Action assignments.
Dictionary/Domain You can view terms in a single dictionary/domain combination at a time. If you have not already selected a dictionary and domain to work in during this session, you must select one when you enter the window. If you have already selected them, the domain name appears in parentheses in the window title bar and the dictionary is displayed in the Dictionary drop-down list.
To change domains, select Change Domains from the Options menu.
Status/Notes If a term has one or more notes associated with it, an N appears to the left of the term name. Click Status/Notes to see the notes.
Current/All When you query for terms, select Current to see only actions that are currently applied to terms. Select All to see both current and past assignments.
TMS enables you to assign actions proactively to terms you think may be collected and sent to TMS during the course of a study. You can also query for existing Action assignments and update them, and view past Action assignments.
To create a verbatim term and assign an Action to it, do the following:
From the VTA Maintenance menu, select Maintain Action Assignments.
If the Choose Domain window opens, select a dictionary and domain. If it doesn't open and you want to change the current dictionary/domain combination, select Options and then Change Domain. Then select a dictionary and domain.
In a new row, in the Distinct Verbatim Terms field, enter the name of the verbatim term to which you want to assign an Action.
In the Action list, choose the Action definition you want to assign to the term.
TMS populates the Action Type and Action Text fields with the default values for the Action you selected. See "Action Types" for more information.
In the Action Text field, you can change the default text for this Action to customize it for the current dictionary/domain combination.
Save. TMS saves this Action assignment for the current dictionary/domain combination.
When you reject an Action assignment for a verbatim term, TMS removes the Action from all occurrences of that verbatim term in the current dictionary/domain combination that are owned by TMS. Furthermore, TMS does not apply the Action to subsequent occurrences of that verbatim term in the current dictionary/domain combination.
To delete an Action from a verbatim term:
From the VTA Maintenance menu, select Maintain Actions.
If the Choose Domain window opens, select a dictionary and domain. If it doesn't open and you want to change the current dictionary/domain combination, select Options and then Change Domain. Then select a dictionary and domain.
Enter a query in any field; you can query for a term or for an Action. TMS returns all Action assignments that meet the query criteria.
Click in the row to select the Action assignment you want to delete.
Click Reject Assignment. TMS does not prompt you to confirm the deletion, and removes the Action assignment from this dictionary/domain combination.
You can make the following changes to existing Action assignments:
Change a term's assignment to an entirely different Action. Only one Action can apply to a term at a time in a particular dictionary/domain combination. If you change the Action, TMS applies the new Action to current and future occurrences of the term in the current dictionary/domain combination.
You can change the Action text. In an external Action (answerable or unanswerable) this is the default text displayed in the external system. For Internal Actions this text is displayed within TMS, in the Classify VT Omissions window and Approve Action Assignments window.
The external system omission status can be changed only in the Action definition; see "Defining and Using Actions" for more information.
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The Reclassify Verbatim Terms window enables you to reclassify and declassify verbatim terms. The reclassification process changes the mapping of a verbatim term from one dictionary term to another. By contrast, declassification breaks a verbatim term's mapping without remapping it to a new dictionary term. Declassifying a verbatim term creates an omission.
You may want to reclassify or declassify a verbatim term that has already been classified if:
You add a term to a dictionary that is a better match for a verbatim term than the one to which it is now mapped.
You do not like a Candidate Term of type Nonapproved. (You must either accept Candidate Terms of type Nonapproved or reclassify the verbatim term; see "Candidate Terms and Search Objects".)
You make a mistake during manual classification.
You may map a verbatim term to a different dictionary term in different TMS domains. In the Reclassify Verbatim Terms window you see classified verbatim terms in one TMS domain at a time, and the changes you make affect only that TMS domain unless the Global? box is selected. See "Global and Domain VTAs".
VTAs that you create during reclassification inherit the approval status of the VTA they replace. TMS maintains a full audit trail of reclassifications.
Note:
VTIs are always approved and are never global.When you reclassify a verbatim term, all version-specific Informative Notes for the old VTA or VTI expire, and TMS assigns them the same end timestamp as the old VTA or VTI. The new VTA or VTI will not have these Informative Notes associated with it.
To access the Reclassify Verbatim Terms window, you must either:
Have tms_reclassify_priv privileges, in which case you can reclassify VTAs and VTIs created by any user.
Have classified a verbatim term recently (within the number of hours set in the reference codelist TMS_CONFIGURATION), in which case you can see only VTAs and VTIs you have created, and can modify only those you created within the set time limit.
There are two tabs in the upper half of Reclassify Verbatim Terms that display verbatim term information:
The Distinct VTAs/VTIs tab lists each distinct verbatim term that meets your query criteria. If the same term has been entered for ten patients, the term is displayed once.
The All VTAs/VTIs tab lists every source term—verbatim term occurrence—that meet your criteria. If the same term has been entered for ten patients, all ten occurrences are displayed. Auxiliary information about each occurrence is also displayed.
For each VTA or VTI they describe, both tabs display the following information.
Glb? (Global?) If selected, the VTA is available in all domains. (VTIs are never global.)
Type VTA means the term is classified with a verbatim term assignment to a unique dictionary term. VTI means the term is classified with a verbatim term individual to a nonunique dictionary term, using auxiliary information.
Subtype VTAs and VTIs are either Misspelled or Accepted (correctly spelled).
Appr? If selected, the VTA is approved for use in Autoclassification and manual classification. If deselected, TMS proposes the VTA as a Candidate Term but manual approval is required for each occurrence. (VTIs are always approved.)
In addition to the fields described in "Common Fields in the Distinct and All VTAs/VTIs Tabs" the Distinct VTA/VTI tab includes information about the dictionary term to which the VTA or VTI is linked.
Dictionary Term By default, this field shows the dictionary term to which the verbatim term is assigned, if any. If you specify a Dictionary Term Display Procedure for this dictionary, this field may display a different term depending on how you wrote the procedure. See "Writing a Procedure to Change the Dictionary Display" for specifics on the use of this functionality.
DT Appr? If checked, the dictionary term is approved. If unchecked, the dictionary term is not approved. Depending on the Non Appr DT setting for the current dictionary/domain combination, you may or may not be able to classify a verbatim term to a nonapproved dictionary term. See "Assigning a Dictionary to a Domain" for more information.
The remaining fields on the Distinct Verbatim Term Assignments block provide read-only information about the term displayed in the Dictionary Term field. For details on these fields, see "Current Level Block Fields".
In addition to the fields described in "Common Fields in the Distinct and All VTAs/VTIs Tabs" the All VTAs/VTIs tab includes information about each occurrence of each verbatim term in the selected database:
Update? If checked, data relating to this verbatim term has been updated, so the VT is flagged to be updated in the external system during the next data exchange. These changes—such as a change to the verbatim term, a change to the dictionary term to which it is assigned, a change to the VTA or VTI, or a change to the relation—may be made in the repository or during a dictionary upgrade, for example.
Source Term ID Unique identifier for this verbatim term.
Occurrence ID Unique internal identifier for this occurrence of this verbatim term.
External System The external system that fed the term into TMS.
Value 1 - 8 These fields can contain information about the verbatim term occurrence that is stored in the external system. Your company determines what information, if any, is displayed in these fields. If text is displayed in blue you can select it and click the Drill Down icon to see additional information. For instructions on setting up this feature, see "Defining External System Information in TMS".
Auxiliary Information If the current dictionary has nonunique terms in its classification level, TMS displays the auxiliary information collected for each source term at the bottom of the All VTAs/VTIs tab.
Use the Repository Terms block to search for the dictionary term or VTA to use as the new target of the changed VTA. After you execute a query, TMS displays terms that match the query in the classification level(s) and the verbatim term level. You can then choose one of the matches as a target for the reclassification.
For information about these fields, see "Current Level Block Fields".
Before entering your query criteria in one of the fields, choose which of these data groups you want to include in your search:
Current VTAs and dictionary terms, or all VTAs and dictionary terms (both current and deleted)
Approved dictionary terms only, Nonapproved dictionary terms only, both of these subsets, or none. Choosing None restricts your search to VTAs.
Approved VTAs only, Nonapproved VTAs only, both of these subsets, or none. Choosing None restricts your search to dictionary terms.
in addition, you can use these buttons:
Highlight a term and click Above to see all of a term's relations in levels above. See "The Above Button".
Highlight a term and click Below to see all of a term's relations in levels below. See "The Below Button".
Select Extended Search to open the Extended Search window. See "Using the Extended Search Button".
Reset the filter. See "Setting Filters".
Filter on auxiliary information. See "DT Filter for Auxiliary Information".
From the VTA Maintenance menu, select Reclassify Verbatim Terms. TMS opens the Reclassify Verbatim Terms window, and sets default values for many of the fields according to your profile settings. See "Setting Filters and Creating Activity Lists" to change these values for your session.
In the Distinct VTAs/VTIs tab, select one search criterion for VTAs:
No restricts your search to VTIs.
Approved VTAs only, Nonapproved VTAs only, or All VTAs.
Note:
This filter does not apply to VTIs, which are always created as Approved. If the current dictionary has nonunique terms in the classification level, all VTIs are displayed.Query for the VTA or VTI you want to reclassify.
In the Repository Terms tab, select one search criterion for both VTAs and dictionary terms:
No retrieves none.
Approved only, Nonapproved only, or All VTAs or dictionary terms.
Note:
This filter does not apply to VTIs, which are not displayed here.Select one:
Current retrieves current terms only.
All retrieves current and deleted terms.
Query for terms to which you might want to reclassify the verbatim term.
Highlight the term to which you want to reclassify the verbatim term and click Reclassify. The new classification is immediately available.
(Optional) To add an Informative Note for this reclassification, click Status/Notes or select Status/Notes from the Options menu. See "Using the Status/Notes Pop-up Window".
You can declassify a verbatim term without reclassifying it to another dictionary term. This declassification creates an omission. The newly created omission will appear in the Classify VT Omissions window once you run Synchronization in the local TMS instance from which the verbatim term originated. In earlier releases, you had to run Autoclassification to see the omission created in TMS; now, only Synchronization is necessary. However, to update discrepancies in Oracle Clinical, you still must run Batch Validation.
When you declassify a verbatim term, all Informative Notes associated with that VTA expire.
From the VTA/VTI Maintenance menu, select Reclassify Verbatim Terms. TMS opens the Reclassify Verbatim Terms window, and sets default values for many of the fields according to your profile settings. See "Setting Filters and Creating Activity Lists" to change these values for your session.
In the Distinct VTAs/VTIs tab, select one search criterion for VTAs:
No restricts your search to VTIs.
Approved VTAs only, Nonapproved VTAs only, or All VTAs.
Note:
This filter does not apply to VTIs, which are always created as Approved. If the current dictionary has nonunique terms in the classification level, all VTIs are displayed.Query for the VTA or VTI you want to declassify.
To declassify a VTA, stay in the Distinct VTAs/VTIs tab. You can also declassify a VTI in this tab, but to see its auxiliary information, select it in the Distinct VTAs/VTIs tab and then open the All VTAs/VTIs tab.
Click Declassify or Declassify and Action, which is available from the Distinct tab for VTAs and the All tab for VTIs. If you click Declassify and Action, select an action and modify its text if necessary.
An indication omission can occur in a dictionary like WHO-Drug Format C when a single dictionary term is mapped to multiple terms in the next higher derivable level and the correct derivation depends on the indication for which the drug is being taken by a patient. You can classify indication omissions, creating indication assignments, under the Omission Management menu.
In the Reclassify Indication Assignments window you can:
Reclassify the indication assignment to a different higher level term.
Declassify the indication assignment, creating an indication omission.
The Distinct Indication Assignments tab displays each verbatim term with its indication, the level up to which terms could be successfully derived even before the indication omission was classified, the term that is derived in that level, and the higher level term to which the indication omission is assigned. The Distinct Indication Omissions tab displays each verbatim term/indication combination once.
Query for an indication omission assignment in the Distinct Indication Assignments tab and select it. You can see all occurrences of the same verbatim term/indication combination in the All Indication Assignments tab.
The Higher Level Terms tab automatically displays the higher-level terms that are related to the dictionary term selected in the Distinct Indication Assignments tab.
To reclassify the current lower level dictionary term to a different higher level term for the current verbatim term/indication combination, select the higher level term and click Reclassify.
To declassify the indication assignment and create an indication omission, select the higher level term and click Declassify.
You can use the High-Level Reclassification window to view the verbatim terms that can be reclassified to different derivation paths, and change the higher-level terms to be derived from these verbatim terms on a record-by-record basis.
You may want to use this functionality if the correct classification for a term depends on a characteristic of a patient. For example, an indication may primarily affect one body system in adults and in children. The same verbatim term for the indication needs to be linked to different body systems for adults and children.
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High-level reclassification is effective only where TMS is fully integrated with an external system; otherwise TMS cannot associate changes with the source data.
The relation you create here, which is called a High-level Classification (HLC), supersedes both the Primary Link and a Domain Primary Link that may have been defined for a term.
You can create HLCs only between terms in derivable levels with a Many Cardinality relation on the parent side.
The window includes:
The values you select in these five lists filter different aspects of your data queries.
This list includes all dictionaries associated with the current domain. Select the one in which you want to work.
This list includes all level relations where:
There is Many Cardinality defined on the parent side; that is, where a term in the child level can be related to more than one term in the parent level
The relation between the levels is on the derivation path (both levels are defined as Derivable)
Select HLC to display terms with HLC relations, Non-HLC to display terms that have Primary Link or Domain Primary Link relations, and All Terms to display both of these subsets.
If TMS is fully integrated with an external system such as Oracle Clinical, and your company has set TMS up to import external system information, the external system will appear in the list. Select any one system to see its custom information. If you select All Systems, you see verbatim terms collected from all external systems, but you will not see any custom external system information about the verbatim terms.
Each row represents three relations along the derivation path for a particular occurrence of a verbatim term. An occurrence represents a single patient record, or source term--a single response collected at a particular visit by a particular patient. TMS displays all occurrences of the verbatim term you query for, with the verbatim term on the left and the dictionary levels you chose from the list in the middle and on the right.
The Classif. field shows the type of relation that exists between the two dictionary terms for this verbatim term occurrence. Since a Primary Link is required for Many Cardinality relationships along the derivation path, the classification type for all relations listed here that you have not changed is either Primary Link (PL) or Domain Primary Link (DPL), which overrides the PL in a particular domain. When you modify a classification here, by definition you create a High-level Classification (HLC) that overrides both the PL and the DPL for this occurrence only.
You can query only on the Verbatim Term, Verbatim Term ID, Classif., Source Term ID, Occurrence ID, and External System Info fields.
If you select an external system from the list at the top of the window, TMS displays external system information for the verbatim term occurrence on the far right. If more information is available for these external values, they are displayed in blue. To view the information, select Drill Down from the Navigate menu, or click the Drill-down icon.
To derive a different dictionary term for a particular occurrence of a verbatim term (a single patient record):
Select a value from the External System and Dictionary lists (see "Lists").
From the Dict. Level - Assigned Level list, select the pair of levels where the level from which you want to derive a different value is the assigned level (parent level; displayed on the right).
In the upper block, query for the verbatim term for which you want to derive a different term.
Scroll down, using the Source Term ID, Occurrence ID or external system information to find the occurrence of the verbatim term for which you want to derive a different term.
Highlight the occurrence.
In the lower block, enter a query for related terms in the parent level. If you enter an unrestricted query, TMS displays all related terms in the parent level, and shows which ones are defined as Global Primary Links and/or Domain Primary Links.
Depending on the type of classification that already exists for this occurrence, do one of the following:
If the occurrence is currently linked to the Global or Domain Primary Link, and you want to override that with a link to a different term, do the following:
Highlight the term you want to derive for this occurrence.
Click Modify Classification.
Save. TMS creates an HLC for that verbatim term occurrence.
If the occurrence is currently linked to an alternative term via an HLC, and you want to switch to the predefined Primary Link, or, if there is one, the Domain Primary Link, do the following:
Click Undo Classification.
Save.
Notes:
Domain Primary Links supersede Global Primary Links. If a Domain Primary Link exists but you want to derive the Global Primary LinkGlobal Primary Link for a particular patient record, you must create an HLC for that verbatim term occurrence.
You can define and update global and Domain Primary Links in the Maintain Repository Data window. To define a Domain Primary Link, you must be in the domain in which you want a Domain Primary Link.
Domain copying enables you to copy VTAs and Actions from one domain to another. The process is flexible: for example, you can copy every VTA into the target domain, or only those of a particular approval status or subtype. Coupled with the use of virtual dictionaries, domain copying can help you conduct studies against multiple versions of a dictionary. This section includes:
Some of the rules that govern domain copying operations depend upon your dictionary and domain choices. Consult the following sections before copying VTAs and Actions from one domain and dictionary to another.
You can copy information from multiple source domains into a single target domain, but not in a single transaction. The Copy Domains window restricts domain copying to exchange between a single source domain and a single target domain, so you must copy each source domain's information individually.
When different VTAs and Actions exist in the source and target domains, the existing target domain's information takes precedence; keep this hierarchy in mind as you plan the order in which you load the multiple source domains into the target.
Actions and VTAs can be copied between domain/dictionary combinations regardless of dictionary structure.
You cannot copy Actions to or from the Global domain.
To copy VTA and/or Action information from one domain to another using the Copy Domains window:
From the VTA Maintenance menu, select Copy Domains. The Copy Domains window opens.
Specify the source domain and dictionary in the window's Source block.
In the Target block, specify the target domain and dictionary.
Select Copy VTAs? to copy VTAs, and Copy VTIs? to copy VTIs from the source to the target domain.
If you choose to copy VTIs, additional fields appear. For each auxiliary information level in the source domain dictionary, specify the equivalent level in the target domain dictionary.
Note:
Providing these mappings creates more accurate matching critieria for the copy logic.Choose the SubType of the VTAs and VTIs you want to copy into the target domain. You can choose to copy all subtypes, only Accepted, or only Misspelled VTAs and VTIs.
From the Appr? list, choose the approval status of the VTAs you want to copy into the target domain. You can choose to copy only Approved VTAs, only Nonapproved VTAs, or all VTAs.
Select the Copy Actions? box to copy the Actions that have been linked to verbatim terms into the target domain.
Click Copy. TMS records any errors resulting from this domain copying in the TMS error log; see for details.
The package TMS_USER_MT_DOMAIN handles domain copying from external systems. See the Oracle Thesaurus Management System Technical Reference Manual for package details and restrictions.
The domain copying process can generate errors when the source and target domain and dictionary are incompatible. For example, if the copying operation would overwrite a VTA or Action in the target domain/dictionary, or change its approval status or subtype, TMS will not change the VTA in the target domain/dictionary combination, and generates an error.
If a domain copying operation generates any errors, TMS saves all of the operation's errors in an error log. You can check if your domain copy generated errors by clicking View Errors after the domain copying operation completes. TMS opens the Maintain Domain Copying Error Logs window.
To view the errors generated from one domain copying transaction, select the error log's row from the upper half of the window. TMS displays the specific errors from that transaction in the lower half of the window, listing the details of each error in the Error Msg field.
The information in error messages is delineated by pound (#) symbols, as in the following example. Alternating items appear in bold here for clarity; the errors themselves appear as delineated strings in the Error Msg field.
Source Domain=BASE#Source Dict=BASE#Target Domain=GLOBAL#Target Dict if present=BASE#SourceVT=TROUSERS#SourceVTId=1000499#Dict Term=SLACKS#Dict Term Id=1000487#ORA-20000: 245800-Record already exists.
The first four items identify the source domain/dictionary combination and target domain/dictionary combination for this operation. The next four items describe which VTA is inconsistent in the source and target; the message provides the name and ID of the source verbatim term, and the name and ID of the dictionary term to which it classifies. The final item is the error message itself; in this example, the source VTA already exists in the target domain and dictionary.
You can also delete specific error logs by clicking in the log's row and selecting Record, then Delete, or delete all domain copying error logs by clicking the Delete All button at the bottom of the window.
Note:
The Delete All button deletes all of the domain copying error logs for all users in the installation.When you copy information from one TMS domain to another, you must reassign any elements from an external system that were associated with the original domain to the new domain.
In Oracle Clinical, for example, you must reassign projects and studies that are assigned to Domain A in the above example to Domain B. To switch domains for a study or project:
Navigate to Maintain Domain Elements; from Oracle Clinical's Plan menu, select TMS Domains Elements. Oracle Clinical prompts you to choose a study or project.
Choose a study or project.
Query for the domain you want to reassign, and click TMS Domain Elements.
Select a new domain, and click Save.
If you are using Oracle Clinical, the combined use of domain copying and virtual dictionaries allows you to continue coding some studies against a specific release of a dictionary while updating your base dictionary for use by other studies.
For example, and Study 12345 is coding against Domain A with one version of MedDRA 5.0 and your organization updates to the latest version of MedDRA, to continue coding Study 12345 against MedDRA 5.0:
In TMS, create a virtual dictionary with a cut-off date just prior to the date of the base dictionary update. This virtual dictionary will contain MedDRA 5.0 data and all the changes made to the dictionary until the cut-off date.
Create a new domain (Domain B) that contains the virtual dictionary for MedDRA 5.0.
In Oracle Clinical, go to Plan, then TMS Domains, and change to the virtual dictionary for the desired studies.
Copy domain information from the Domain A to Domain B. The next time you run Batch Validation for the selected study, the new dictionary will be used as the target/coding dictionary.
The following are VTA Maintenance reports:
The Non Approved VTs report displays nonapproved VTs in chronological order, with the most recent first. It also displays actions and notes associated with the VTs.
Note:
You can generate this report in MS Excel.The Non Approved VTs report provides the following information about VTs:
The dictionary and domain names
The verbatim term
Dictionary term to which the VT maps
The dictionary term's level
The VT's status
The user ID of the person who created the VT
The report provides the following information about actions:
The dictionary and domain names
The verbatim term
The action text
The action code as it appears in TMS
The action description
The user ID of the person who created the action
To run the Non Approved VTs report:
Select the Nonapproved VTs Report from the VTA Maintenance menu.
Fill in the general report specifications. See "Setting Parameters."
Enter a value for each job-specific parameter:
Active Dictionaries: Select the dictionary from the list of active dictionaries, for which you want to run this report.
Domain: You can optionally select a domain if you want the domain name to appear in the report along with the dictionary name.
Note:
If you select a domain here that does not contain the dictionary you want to run the report for (selected in Active Dictionaries above), then your report will not show any data.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.
Submit the job. See "Running a Job."
This report is useful when you are planning to move to a new domain and a different dictionary or a new rendition of the same dictionary; for example from WHO-ART to MedDRA. This report displays information about the amount of recoding that is required for this move. You can use the Copy Domain feature to make the coding similar in the two domains, if you so require. See "Copying Domains".
The report displays:
The omissions that will remain omissions
The omissions that will be resolved (VTAs or VTIs)
The VTAs and VTIs that will remain VTAs or VTIs
The VTAs and VTIs that will be reclassified
The VTAs and VTIs that will be declassified (omissions)
For each verbatim term, the report displays:
The term type (VTA or VTI)
The VT status and ID
The original domain's dictionary term and its ID
The new domain's dictionary term and its ID
To run the Classification to a New Domain Report:
Select the Classification to a New Domain Report from the VTA Maintenance menu.
Fill in the general report specifications. See "Setting Parameters."
Enter a value for each job-specific parameter:
Original Domain: Select the domain from which you are moving your classifications.
Original Dictionary: Select the dictionary under the original domain from which the VTAs need to be reclassified.
New Domain: Select the domain to which you are moving the VTA classifications.
New Dictionary: Select the dictionary under the new domain to which the VTAs will be reclassified.
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.
Submit the job. See "Running a Job."
You can keep track of the coding changes that a Verbatim Term (VT) has undergone within a specified time period and data set with the VT Modifications Report. It specifies the type of change in the VT - classification, declassification, reclassification and applied actions. You can also view the author of the change and the reason for it.
You can confine your search to a verbatim term in a particular external system or include all external systems. You can define an External Value to narrow your search to a particular data set. For example, in Oracle Clinical, you can define an External Value as a study and assign an External Value Number to each study. TMS generates a report based on the specified study only.
The Verbatim Term Modifications Report displays the following:
Dictionary: The selected dictionary or dictionaries on which the report is run.
Domain: The active domain or domains on which the report is run.
Verbatim Term: The Verbatim Term queried.
External Value: This indicates the query criteria, if any.
VT Status: The changes undergone by the VT (classification, declassification, reclassification and applied actions), the coder User ID, and the time of change.
Dictionary Term & Action Text: This is the Dictionary Term for an approved VTA. For an Action, the Action text is displayed.
To run the Verbatim Term Modifications Report:
Select VTA maintenance in the navigator window.
Select Jobs.
Select VT Modifications.
Fill in the general report specifications. See "Setting Parameters."
Enter a value for Job Specific parameters:
Active Dictionaries: Choose the dictionary on which to run the report. TMS searches all dictionaries by default.
Domain: Select the appropriate domain. TMS searches all domains by default.
Coder User Name: Select the User Name of the coder.
External System: Select the relevant External System.
External Value number: Select the relevant External Value Number from the field. If not coded in the External System, the report displays External Value Number as N/A.
External Value: This field is activated only if the External Value Number is already selected. The value corresponds with the External Value Number as pre-defined.
Verbatim Term: Type in the Verbatim Term to be queried.
Start Date: Type in the Start Date of the time period for which to run the report. Use the MM-DD-YYYY format where MM is the first three letters of the month. The default date is JAN-01-1900.
End Date: Type in the End Date of the time period for which to run the report. Use the MM-DD-YYYY format where MM is the first three letters of the month. The default date is AUG-15-3501.
Template: Select the report template. If your company has created a custom template, it appears in the list of values. The Oracle Template is the default template.
Submit the job. See "Running a Job."
This report displays X Areas for which the data exchange job between the external system and TMS should be run. If the external system is Oracle Clinical, an X Area is a study, and the report displays the study names for which Batch Validation should be run.
If you are not running the data exchange job on a regular basis—for example, you have finished data collection in a study—you can run this job to detect X Areas where data cleaning in the external system or changes such as reclassifications in TMS have produced data changes that should be propagated to the other system.
If the external system is not Oracle Clinical, you can write a function to display a meaningful name for X Areas if appropriate; see "Defining the External System in TMS" and "Defining Views and Functions in the External System".
The report displays the X Area and other external system information for:
omissions that originated in all instances
source terms that originated locally only
To run the report, do the following:
Fill in the general report specifications. See "Setting Parameters."
Enter values for the following job-specific parameters:
External System. Select the external source data system whose X Areas you want to know about.
Template. Select a template; if your company has created a custom template, it appears in the drop-down list. The Oracle template is the default.
Submit the job. See "Running a Job."