Performing High-Level Reclassification

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.

This section includes:

• Rules and Constraints
  
• The High-Level Reclassification Window
  
• Performing High-Level Reclassification
  

Rules and Constraints

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 High-Level Reclassification Window

The window includes:

• Lists
  
• Upper Block: Classifications
  
• Lower Block: Higher-level Terms
  

Lists

The values you select in these five lists filter different aspects of your data queries.

• Dictionary: This list includes all dictionaries associated with the current domain. Select the one in which you want to work.

• DT Level - Assigned Level: 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)

• Classification Type: 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.

• External System: 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.

• Eligibility: When set to Terms Eligible for HLC, queries will return terms that have multiple parents.

Upper Block: Classifications

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.

Lower Block: Higher-level Terms

The lower block displays all related terms in the higher derivable level (assigned level) that you chose from the list at the top of the window.

Performing High-Level Reclassification

To derive a different dictionary term for a particular occurrence of a verbatim term (a single patient record):

1. Select a value from the External System and Dictionary lists (see Lists).
2. 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).
3. In the upper block, query for the verbatim term for which you want to derive a different term.
4. 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.
5. Highlight the occurrence.
6. 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.
7. Depending on the type of classification that already exists for this occurrence, do one of the following:

For more information, see:

• Modify Classification
  
• Undo Classification
  

Modify Classification

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:

1. Highlight the term you want to derive for this occurrence.
2. Click Modify Classification.
3. Save. TMS creates an HLC for that verbatim term occurrence.

Undo Classification

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:

1. Click Undo Classification.
2. Save.

   Note:

   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.