Maintaining Action Assignments

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.

In order to prevent a verbatim term from not autocoding, the existing Action Assignments feature will be extended to include a verbatim term that may exist as a dictionary term in the domain/dictionary. The administrator will have to manually add the verbatim term to the Maintain Action Assignment. A verbatim term added to the “negative list" will be supported in a domain/dictionary.

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.

This section includes:

• About the Maintain Action Assignments Window
  
• Assigning an Action to a Term
  
• Rejecting an Action Assignment
  
• Modifying an Existing Action Assignment
  
• Negative List
  

About the Maintain Action Assignments 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.

• Create Negative list. For information, see Negative List.

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.

Assigning an Action to a Term

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:

1. 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.

2. 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.
3. 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.

   If the action type is "unanswerable", the Glb? is enabled. Glb? indicates that an unanswerable action exists across all domain/dictionaries with the same base dictionary.

4. In the Action Text field, you can change the default text for this Action to customize it for the current dictionary/domain combination.
5. Save. TMS saves this Action assignment for the current dictionary/domain combination.

Rejecting an Action Assignment

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:

1. 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.

2. 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.
3. Click in the row to select the Action assignment you want to delete.
4. Click Reject Assignment. TMS does not prompt you to confirm the deletion, and removes the Action assignment from this dictionary/domain combination.

Modifying an Existing Action Assignment

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.

Negative List

To create a Negative list action:

1. Create Action Definitions.

   1. Enter Action as DONOTAUTOCODE.

   2. Select Action Type as Unanswerable and Status as Active.

   3. Leave Base Answerable Action field blank.

   4. Enter Text of "Please be more specific in describing the adverse event."

   5. Select an External System and Omission Status of DMW and TMS INV REVIEW.

   6. Save the record.

2. Maintain Action Assignments.

   1. Enter a dictionary term of Pain in the Distinct Verbatim Terms field.

   2. Select Action as DONOTAUTOCODE. This will default in Action Type of Unanswerable and Action Text of "Please be more specific in describing the adverse event."

   3. Save the record.

3. Send in a source term of Pain into TMS (through API or an external system, that is DMW/OC).

4. Classify VTO.

   1. Pain is displayed with a status of External Action in the Distinct Verbatim Term Omissions tab.

   2. Pain is displayed with Action DONOTAUTOCODE and Action Text in the All Verbatim Term Omissions tab.

When the NEGATIVELIST is set to Yes, then the Glb? check box will be active for Unanswerable actions. Checking global will apply the action assignment to all domains/dictionaries for the same base dictionary.

When the Global check box is unchecked, any actions that were applied will remain in the domain/dictionary where they were applied. The action will be removed from any domain/dictionary where it was not applied.

When a global unanswerable action is rejected, it will be removed from all domains/dictionaries.