Summary

This article describes the handling of codes and synonyms within the study using the interface of the code manager.

Table of Contents

• Access Code Manager
• Manager-Level Actions
  • Complete Partial Codes
  • Search For and Complete Uncoded Codes
  • Update Codes
  • Reset Codes
  • Approve Codes
  • Create Query
• WHO Drug Automatic Coding
• Creating Synonyms
• Available Columns and Filter Types

The Code Manager provides an interface to the user for the handling of codes and synonyms within the study.

Access Code Manager

From within a study hover over the Codes tab to  select a view. Once selected, you will have the option to toggle between the All Codes table and the WHO Drug Dictionary table. The WHO Drug Dictionary offers additional columns with WHO Drug specifics (see table below for column details).

Manager-Level Actions

Certain actions are provided to the user by way of the dropdown actions bar in the Manager Table. These actions are differentiated from those available in the green ‘Actions’ tab at the top-right corner of the screen in that they are applicable to both individual items and groups of items selected from the table. These are described below.

Complete Partial Codes

In some cases, the term entered for a code may match multiple codes in the dictionary. In this case, the Code Manager will only partially code the term. The Coder or Code Approval roles will then need to select the correct code as described below.

In the Status column of Code Manager, partially coded terms are designated by the icon in the ‘Status’ column.

1. In Code Manager, click the checkbox next to the partial code(s) that need completing.
2. Choose ‘Complete Codes’ from the dropdown menu.
   
3. A second dropdown menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
5. On the Complete Codes screen, expand and minimize the code trees by clicking the ‘+’ and ‘-’ signs.
   
6. Based on the codes in the tree, select the code that should be applied to the term.
   • The system will display a Code Complete screen.
7. Click the ‘Back’ button to return to the Code Manager.

Note: If a code is ever selected in error, it can be reset.

Search For and Complete Uncoded Codes

In some cases, the term entered for a code may not be recognized by Code Manager. In this case, the code will need to be specified manually by a Coder or Code Approval role.

In the Status column of Code Manager, uncoded terms are designated by the icon in the ‘Status’ column.

1. In Code Manager, click the checkbox next to the uncoded terms that require coding.
2. Choose ‘Search for Code’ from the dropdown menu.
   
3. A second dropdown menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
   • The system will display the ‘Code Search’ screen. This screen displays information related to the dictionary being searched, the search term, the search results and any recently used codes. When searching the WHO Drug Dictionary, the Preferred Name, Ingredients and Country (if supported by dictionary format) fields can also be utilized.
     
5. If the needed code is in the Recent Codes table, select it and skip the rest of the steps in this section. Otherwise, continue to step 5.
6. When searching a MedDRA dictionary, choose to search ‘By Name’ or ‘By Code’. When searching a WHO Drug Dictionary, choose to search ‘By Name’, ‘By MP ID’ or ‘By Drug Code’.
   
7. Enter a search term based on the searching method you chose in step 5. If searching the WHO Drug Dictionary by name, you may also choose to search by Preferred Name, Ingredients, or Country, if known.

Note: Use an asterisk (*) before and after the search term when there is uncertainty about the exact search term.

8. Click the ‘Find’ button.
   • The search results table will display all codes that match the search criteria. For searches of WHO Drug dictionaries (and dependent about additional criteria), the search results can include additional information such as the Drug Code, Ingredients, Country, MAH, Pharm Form, Pharm Strength, and more.
     
9. Repeat steps 5-7 as needed to refine your search.
10. Click the code to select it.
    • If multiple codes match the term, the system will prompt you to complete the code.

Note: If this term should always be associated with this code, consider adding it as a synonym.

11. Once the steps above have been completed, the page will update and display the message ‘The code has been updated’.

Update Codes

Updating codes can be useful when synonym tables or dictionaries are upgraded. This action attempts to automatically re-code the term if the code has changed.

1. In Code Manager, click the checkbox next to the code(s) that need updating.
2. Choose ‘Update Codes’ from the dropdown menu.
   
3. A second drop down menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
5. If ‘All Filtered Rows’ is chosen, you will be redirected to a confirmation page. Confirm that the filtered criteria is correct and click ‘Yes’ to complete the action or ‘No’ to cancel the action.

The code’s status will change to ‘Complete’, ‘Partial’, or ‘Uncoded’ depending on the term, the dictionaries used and the study’s configuration.

Reset Codes

When a code was automatically coded or manually coded incorrectly, you can reset a code so that it returns to the ‘Uncoded’ status. The code can then be manually completed.

1. In Code Manager, click the checkbox next to the code(s) that need to be reset.
2. Choose ‘Reset Code’ from the dropdown menu.
   
3. A second drop down menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
5. If ‘All Filtered Rows’ is chosen, you will be redirected to a confirmation page. Confirm that the filtered criteria is correct and click ‘Yes’ to complete the action or ‘No’ to cancel the action.

The term’s status will change to ‘Uncoded’ and must be manually completed.

Approve Codes

After codes have been completed, they can be approved in Code Manager by those with Code Approval permissions.

Unapproved codes are designated by the icon in the ‘Approval Status’ column. Approved icons are designated by the icon in the ‘Approval Status’ column.

1. In Code Manager, click the checkbox next to the code(s) that need approval.
2. Choose ‘Approve Codes’ from the dropdown menu.
   
3. A second drop down menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
5. If ‘All Filtered Rows’ is chosen, you will be redirected to a confirmation page. Confirm that the filtered criteria is correct and click ‘Yes’ to complete the action or ‘No’ to cancel the action.

The code approval status will change from ‘Unapproved’ to ‘Approved.’

Create Query

Code concerns warranting further clarification may require a query.

1. In the Code Manager, click the checkbox next to the code(s) prompting the query or queries.
2. Choose ‘Create Query’ from the dropdown menu.
   
3. A second drop down menu will appear to the right. Select ‘Checked Rows’ or ‘All Filtered Rows’.
4. Click the ‘Go!’ button to the right of the second dropdown menu.
5. In the ‘Create Query’ box, confirm the Query Text and edit as needed.
   
6. Click the ‘Create’ button to continue or the ‘Close’ button to cancel the creation.

WHO Drug Automatic Coding

At the point of saving data, the system will attempt to find an exact match in the configured dictionary. In the case of WHO Drug coding, the following automated process will be applied when multiple codes are found with the same drug name:

1. The Preferred Name will be assigned (contains Sequence_Number_2: 001)
2. If multiple Preferred Name exist or no Preferred name exist the code with Sequence_number_1: 01 shall be assigned.
3. If multiple Sequence_number_1: 01 exist or no Sequence_number_1: 01 shall be assigned exist and the dictionary is C or C3 format the system shall assign the code with country as Unspecified or Not Applicable.
4. If there are multiple entries with country as “Unspecified” or “Not Applicable”, the system will assign the entry with the lowest MD or DD code.

Creating Synonyms

From the Coding Manager, you may also create synonyms for any currently existing codes. This is done by clicking the green icon beneath the column labeled ‘Create Synonym’. For more details on creating and using synonyms see the Synonym Manager page.

Available Columns and Filter Types

The Code Manager has many columns that can be dragged and dropped between the Manager and Filter Tables. The values of certain columns also serve as links to the Casebook. The following table defines each column, the actions made available through the column value and the filters and sorts available.

WHO Drug Dictionary Additional Columns

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