Classification Concepts

The process of assigning a source term—a term collected during a clinical trial as a response to a CRF question—to a dictionary term is called classifying the term. After loading a group of source terms, you run the Autoclassification process, which classifies as many terms as possible automatically:

• If a dictionary term exists that is exactly the same as the source term and is unique in the coding level, the process classifies the source term to the dictionary term, creating a Verbatim Term Assignment (VTA).

• If a dictionary term exists that is exactly the same as the source term and is NOT unique in the coding level but has auxiliary information, the process can classify the source term with the same auxiliary information to the dictionary term, creating a Verbatim Term Individual (VTI); see Nonunique Coding Level Dictionaries for more information.

• If an existing VTA—either automatically or manually created—matches the source term, the process classifies the source term to the VTA.

• If an existing VTI—either automatically or manually created— matches the source term and its auxiliary information, the process classifies the source term to the VTI.

• If a VTI has no auxiliary information, TMS will not match the source term. If a VTA and VTI exist on the same verbatim term, TMS will select the VTA. TMS selects VTI only if the source term contains auxiliary information.

If Autoclassification cannot classify a term, it creates an omission. A user must classify each omission, manually creating a VTA or VTI. Autoclassification then classifies each subsequent occurrence of the same source term to the manually created VTA or VTI.

A user can classify an omission to an existing VTA, but not to an existing VTI. When a user classifies a term to an existing VTA, behind the scenes TMS maps the verbatim term directly to the dictionary term specified by the VTA.

See Autoclassification for more information.

Misspelled VTAs and VTIs

It is possible to designate a VTA or VTI as misspelled, and a dictionary term can have any number of misspelled VTAs and VTIs; for example, the dictionary term acetyl salicylic acid might have misspelled VTAs asperin and aspurin as well as (not misspelled) aspirin. When you classify a term, you must select either Misspelled or Accepted (not misspelled).

Approved and Unapproved VTAs

In each dictionary/domain you specify whether you want VTAs to be created as Approved or Unapproved. Unapproved VTAs require explicit manual approval for each occurrence.

• If VTAs are created as Approved, no further action is required. Autoclassification maps all occurrences of the term to the Approved VTA. However, it is possible to declassify or reclassify a verbatim term.

• If VTAs are created as Unapproved, all occurrences of the term are mapped to the Unapproved VTA until a user explicitly approves the VTA. All subsequent occurrences are mapped to the Approved VTA.

  Note:

  In TMS 5.3 release, VTI can be created on a unique or non-unique dictionary term. In previous releases, a VTI was only allowed on non-unique dictionary terms.

Global and Domain VTAs

A Domain VTA is available for use in classification only in the TMS domain in which it was created. A Global VTA is available across all TMS domains. Domain VTAs take precedence over Global VTAs: if a domain version of a VTA exists in the current TMS domain, you will see only it, even if a global version also exists.

You can promote a Domain VTA to be a Global VTA or demote a Global VTA to a Domain VTA in the Promote/Demote VTAs window.

Note:

You can create VTIs only in a TMS domain.

Classification and Verbatim Term Levels

You can classify omissions to terms in either the classification level of the dictionary, which are dictionary terms, or to terms in the Verbatim Term level, which are previously classified terms (VTAs). If you select a VTA, behind the scenes TMS instead classifies the verbatim term directly to the dictionary term to which the VTA you selected is classified.

Candidate Terms and Search Objects

Your company may set up Search Objects, or algorithms, to supplement the basic Autoclassification process to find possible valid dictionary matches in an automated way. These are presented as candidate terms.

Search Objects are executed in order and run only until candidate terms are found, and the Search Object that found them is displayed in the Search field. You can run Search Objects during manual classification. Unless there have been changes to the database since Autoclassification, you will not find any candidate terms by using a search object whose execution order is lower than the one entered in the Search field. However, you may find additional matches by using a search object with a higher execution order. You can see the order of execution under Definition > Define Search Objects > Search Object Order tab.

Actions

Sometimes you cannot manually classify a term because the term itself is flawed. For example, a term might include two symptoms that cannot be mapped to a single dictionary term, such as headache and nausea. Or a term may be garbled because a data entry operator's fingers were on the wrong keyboard keys; for example sd[otom instead of aspirin. In this case, you can assign a predefined Action to the term and send it back to the external source data system. Actions contain a message; for example, Please split the term or Please clarify. See Defining and Using Actions.

Internal Actions for Unapproved Actions

To minimize the time spent on communication with the external system, you can require that Action assignments be approved before being sent back to the source system. In this case, you allocate an Internal Action as a task to a TMS user to approve an external Action before sending it to the source data system. See Defining and Using Actions.

Discrepancy Message

You can send a message to the external system regarding a single source term in the Classify VT Omissions window. A discrepancy message is not predefined; you enter text specifically for a particular source term. See Applying a Discrepancy Message.

Activities

Your organization can assign tasks, including classifying omissions and approving unapproved VTAs and actions, to you and other users. You can create lists of the tasks assigned to you and use them to organize your daily work; see Creating and Using Activity Lists.

Term Statuses

TMS automatically assigns statuses to terms—omissions and unapproved VTAs—as they go from one stage to the next and become approved VTAs or VTIs. These statuses reflect whether or not they are allocated to a user and whether or not an Action is associated with them. Most statuses have substatuses. See Term Statuses for more information.