Glossary
action
Most commonly, a user-defined message that Oracle Thesaurus Management System (TMS) returns to the external system; see answerable action and Unanswerable Action. In addition, Internal Actions are used for approving external action assignments or for internal communication.
Parent topic: Glossary
action type
The manner in which TMS assigns an Action; a answerable action is assigned at the first instance of an omission but not in subsequent appearances of an omission, a Unanswerable Action is assigned at every instance of the specified omission, and a discrepancy message is assigned to a specific TMS omission and applies to that verbatim term occurrence only.
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activation group
A group of terms that TMS will activate during the same batch job. The group is defined in the Define Activation Groups window, and used during loading, updating, and modifying dictionaries.
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answerable action
A message that a user applies to an unprocessable verbatim term requesting a change to the term in the external source data system. TMS sends the action with the verbatim term to the external system. A user in the external system can either change the term as requested or send a message back to TMS that is visible in TMS.
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approved VTA
A VTA (verbatim term assignment) that TMS can use for Autoclassification.
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autoclassification
Autocoding: the process of searching for exact matches to each new verbatim term occurrence (source term) among both VTAs and dictionary terms in the current domain.
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base dictionary
A dictionary to which you can add, modify, or delete terms and unapproved VTAs (unlike a virtual dictionary). Base dictionaries are useful for studies that require the most up-to-date dictionary information.
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candidate term
When a verbatim term matches a verbatim term previously classified with a Nonapproved VTA, TMS proposes the dictionary term linked by the Nonapproved VTA as the Candidate Term. If another occurrence of the verbatim term occurs in the same domain, TMS allows the user only to accept or reject the Candidate Term. If another occurrence of the verbatim term occurs in a different domain, the user can accept the Candidate Term or manually classify the verbatim term to a different dictionary term. If the verbatim term is linked to different dictionary terms in different domains, and the supplied and predefined domain match search object is linked to the dictionary, TMS presents the Candidate Terms that exist in other domains.
Parent topic: Glossary
cardinality
A characteristic of a relation between two dictionary levels; determines the maximum number of terms (one or many) in a level to which a term in another level may be linked. In TMS this characteristic is represented in the tree structure by the line between related levels: a single line symbolizes Single Cardinality and a branched line symbolizes Many Cardinality.
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classify
Create a verbatim term assignment between an omission and a dictionary term.
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classification
The process of assigning a VTA to a verbatim term. Depending on the verbatim term, the definitions in the dictionary domain, and the type of searches selected for the dictionary, TMS may accomplish classification automatically or may return an omission requiring user input. Only users with the TMS role tms_classify_priv may perform classification.
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classification level
The dictionary level defined as the level in which TMS should search for matches to verbatim terms; verbatim term code level.
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company relation
A relation defined by the user and available to all domains.
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cross-dictionary link
A relationship that you must define between two dictionaries before you can create relations from a term in one dictionary to a term in the other.
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cut-off date
The date after which no dictionary terms may be added to a virtual dictionary.
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declassification
Deletion of a verbatim term assignment. Declassifying a source term creates an omission.
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derivation path
A series of related levels defined as derivable that begins at the classification level and includes all levels from which you want to derive terms. There must be one and only one path from the verbatim term level to derivable levels. Defining levels as derivable makes them part of the derivation path. To actually derive values from derivable levels, you must also define them as reportable.
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derived question
The data collection unit set up in the external system to receive the term or other value TMS returns to the external system after classification.
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dictionary
A set of terms and relations; usually including a vendor-supplied (external) dictionary as its core, plus user-defined company and domain terms.
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dictionary data
Terms and relations associated with a particular dictionary, including external terms supplied by a vendor and user-defined company and domain terms.
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dictionary term
An external, company, or domain term associated with a particular dictionary, such as MedDRA or WHO-Drug.
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dictionary term display procedure
A user-defined procedure used in omission management to show a different term in the derivation path than the classification level term. Selected on a dictionary-wide basis.
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discrepancy
In Oracle Clinical or other external systems, an entry into the Discrepancy Management System created by Batch Validation when (in the case of thesaurus discrepancies) a verbatim term does not match a dictionary term or an Approved VTA; if the appropriate flag is set in the external system, requires resolution in TMS. See also omission.
Parent topic: Glossary
discrepancy message
An Action that you create and assign to a single occurrence of a verbatim term, sent one time only to the external system.
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domain
In TMS, a logical group of data assigned for use in a particular study or other work unit, including external dictionaries, company and domain terms, and VTAs.
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domain element
The link between an Oracle Clinical study or project and the TMS dictionary and domain it uses for reference.
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domain relation
A relation defined by the user and available only within the domain in which it was created.
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domain term
A term defined by the user and available only within the domain in which it was created.
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Domain VTA
A verbatim term assignment available only within the domain in which it was created.
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dynamic dictionary
A dictionary in which the terms do not belong to specified dictionary levels. In TMS, named relations define the linking between terms in dynamic dictionaries.
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external dictionary
A vendor-supplied dictionary; a dictionary maintained and released by an organization external to the TMS customer company.
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external system
An application that is using TMS as its dictionary repository; for example, Oracle Clinical.
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external term
Term supplied by a vendor in an external dictionary such as MedDRA or WHO-Drug.
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global language
The primary language in which a study or project is conducted. When you specify Translation Derivation Links between dictionaries, you must choose which dictionary is in the global language and which is in the local language.
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group level
A dictionary level that contains other levels as sublevels within it; superlevel.
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indication assignment
An indication omission that has been classified; a high-level classification based on the indication for which a drug was taken.
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indication omission
Different instances of the same dictionary coding-level term may be classified to different high level terms based on the indication for which the drug was taken by a patient. In this case, multiple high-level terms are related to a single lower-level dictionary term with no primary path defined. TMS cannot derive the high-level term and creates an indication omission. After a user manually classifies the indication omission, TMS derives all current and future occurrences of the same term for the same verbatim term/indication combination.
Parent topic: Glossary
Informative Note
Data structures that provide more information about one term, relation, VTA, or dictionary as a whole, in the database.
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Informative Note Attribute
Database-wide definitions for the Data Type, Attribute Type, and other properties of an Informative Note. All Informative Notes are based upon an Informative Note Attribute definition.
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Internal Action
An Action that is assigned to a verbatim term for the purpose of approving the assignment of the associated base Answerable Action to the same verbatim term. When the Internal Action is approved, TMS sends the base Answerable Action, with any text modifications made by the approver, to the external system. Internal Actions can also be used to communicate internally with other TMS users.
Parent topic: Glossary
list of values
(LOV, <LIST> function) A list of acceptable values for a field, populated by the system into a list or a shortcut window. Access the LOV by clicking on the arrow of the list, an ellipsis (…) button, or by pressing F9 while your cursor is in the field.
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local language
The secondary language in which a study or project is conducted. When you specify Translation Derivation Links between dictionaries, you must choose which dictionary is in the global language and which is in the local language.
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materialized view
View that provides indirect access to table data by storing the results of a query in a separate schema object. Unlike an ordinary view, which does not take up any storage space or contain any data, a materialized view contains the rows resulting from a query against one or more base tables or views. A materialized view can be stored in the same database as its base table(s) or in a different database.
more information on materialized views is available in the Oracle9i Database Concepts manual (part number A96524).
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Misspelled VTA
A verbatim term assignment that maps an incorrectly spelled verbatim term to an appropriate dictionary term.
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named relation
A type of relation that defines the connection between terms. Named relations are defined on an installation-wide basis, and are used primarily in weak dictionaries.
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Nonapproved VTA
A VTA, or classification of a verbatim term to a dictionary term, that has been created but not approved. The VTA must be manually applied to subsequent occurrences of the same verbatim term in the same domain. During manual classification, the system proposes the dictionary term as a candidate term.
Parent topic: Glossary
occurrence
A single instance of a verbatim term from the external system; for example, a response of a particular patient at a particular visit.
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omission
A verbatim term without a link to a dictionary term; if the appropriate flag is set in the external system, requires resolution by TMS. See also discrepancy.
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parent question
In Oracle Clinical, the question that collects the response, or verbatim term, sent to TMS for classification.
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predict tables
Pre-dictionary tables; TMS tables that hold terms and relations awaiting activation, and terms and relations that have failed activation.
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preliminary data
Data in the predict tables; terms and relations awaiting activation, and terms and relations that have failed activation.
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Primary Link
Defines which single term is considered the predominant relation in a higher dictionary level where more than one term may be related to a single term in a lower level; defines the one term in the multiple-term level that should be derived or used for derivation farther up in the dictionary hierarchy.
Parent topic: Glossary
Primary Path
Defines the derivation path between terms across any number of defined relations. Primary Path Links enable you to specify a Primary Path between a top level term and the coding-level terms without defining a series of Primary Links or Paths to bridge the levels in between.
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Question Set
In Oracle Clinical, defines the data derived from TMS to Oracle Clinical and associates a parent question with one or more derived questions.
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reclassification
Changing a verbatim term assignment so that the verbatim term relates to a different dictionary term.
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Release Label
The unique label that TMS applies to a particular build, or activation, of a dictionary. The Release Label consists of the Release Label Prefix followed by the build number.
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reportable level
A dictionary level whose terms can be reported to the external system as derived terms. You can report a level's terms only if the level's relation with its child is derivable and the external system is set up to call for derived terms.
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search object
Set of algorithms used to search the TMS Repository in order to find matches for verbatim terms during Autoclassification, to find Candidate Terms during manual classification, or to find Repository terms in the Extended Search window.
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source term
A term collected in an external system and sent to TMS for classification. A single occurrence of a verbatim term. In Oracle Clinical, a question response.
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strong dictionary
A dictionary in which all of the terms are stored in dictionary levels.
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superlevel
A level containing other levels as sublevels within it; group level.
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temporary tables
Tables that hold data from vendor-supplied ASCII files before it is loaded into the preliminary tables.
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Translation Derivation Link
A connection between two dictionaries with the same data and dictionary structure, which enables you, given a term in one dictionary, to find the corresponding record in the other. These links serve to translate dictionary data in studies being conducted in two different languages.
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Unanswerable Action
A message that a user applies to an unprocessable verbatim term. TMS sends the action with the verbatim term to the external system. Any messages sent by a user in the external system to TMS are not visible in TMS.
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upgrading (dictionary)
Changing an external dictionary's contents when a new version is released.
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user profile
The set of profiles that have been assigned to a TMS user, and the hierarchy of Search Orders that enable TMS to determine which profiles to use for defining default values.
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verbatim term
Free-form text initially entered or loaded into the external system; source term; external system question response.
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verbatim term assignment (VTA)
The mapping between a verbatim term and a dictionary term in a dictionary whose classification level contains unique terms. VTAs can be created either by TMS during Autoclassification, if a direct match or Approved VTA exists, or by a user during manual classification.
Parent topic: Glossary
verbatim term individual (VTI)
The mapping between a verbatim term and a dictionary term in a dictionary whose classification level contains non-unique terms, created either by TMS during Autoclassification, if a VTI exists for a verbatim term with the same auxiliary information, or by a user during manual classification.
Parent topic: Glossary
virtual dictionary
A dictionary containing all the terms and assignments for a base dictionary at a specified point in time, the cut-off date. Virtual dictionaries enable you to continue coding verbatim terms for a clinical study against one version of a dictionary while the base dictionary changes.
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weak dictionary folder
A TMS dictionary that contains one or more dynamic dictionaries. Each level of a weak dictionary folder can be a fully defined dictionary.
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X Area
The external system unit used in data exchange with TMS. If the external system is Oracle Clinical, an X Area corresponds to a clinical study, identified by the clinical study ID. For other external systems, the X Area should be a unique number that defines the external system batch processing unit.
Parent topic: Glossary