Managing Synonym Lists

Vault Coder uses Synonym Lists to inform autocoding. When autocoding, Vault compares pending Code Requests to Synonyms in the form’s Synonym List. If Vault finds a match between the pending request’s properties and a Synonym, Vault autocodes the request and assigns the code from the Synonym. You can manage the available Synonym Lists in your vault, including creating new Synonym Lists and upversioning existing Synonym Lists, from Coder Tools > Synonym Lists. From here, you can also review and either approve or reject new Synonyms for a Synonym List as coders request to add them.

Each Synonym List record contains a number of Synonym records. Each Synonym record contains a Verbatim with its assigned dictionary code. The Synonym may include other fields that are used for coding decisions such as Indication and Route. Each Synonym List is associated with a specific MedDRA or WHODrug dictionary release.

You can access Synonym Lists in your vault from Coder Tools > Synonym Lists.

Accessing Coder Tools

To access the Coder Tools administration area, click the Tools tab in the primary navigation bar, and then click Coder Tools.

Once in Coder Tools, you can click the sub-tabs to navigate to different areas within.

Viewing Synonym Lists

Once you navigate to Coder Tools > Synonym Lists, Vault displays a list of all existing Synonym Lists in your vault. To view a specific Synonym List, click that synonym list’s Name in the listing. This opens the Synonym List Details page, which lists all Synonyms in the list.

To locate a specific Synonym, you can search for it from this page.

Create a Synonym List

You can create new Synonym Lists from Coder Tools > Synonym Lists. You can also create Synonym Lists by importing them as a CSV file. See details below. Once you create a Synonym List, you can assign it to a Form. Once coders begin coding, they can request to add terms to the Synonym List.

To create a new Synonym List:

1. Navigate to Coder Tools > Synonym Lists.

2. Click New Synonym List. Vault opens the New Synonym List dialog.

3. Enter a Name for your synonym list.

4. Select a Dictionary to associate with your Synonym List.
5. Optional: Select a Status. The default status is Active.
6. Click Confirm.

Vault creates your Synonym List record. You can now add Synonyms and assign the list to a Form.

Assign a Synonym List to a Form

Before Vault can use a Synonym List for autocoding, and before coders can request to add new Synonyms, you must first assign a Synonym List to a coding Form.

To assign a Synonym List to a Form:

1. Locate the Form you want to edit in Coder Tools > Study Settings > Form Configuration.
2. Hover over the Form to display the Actions menu.

3. From the Actions menu, select Edit.

4. In the Edit Form dialog, select a Synonym List.
5. Click Save.
6. Vault assigns the Synonym List to the Form. Vault now uses this Synonym List to inform autocoding on this Form.

You can edit the Synonym List assignment later.

Unassign a Synonym List from a Form

You can remove a Synonym List from a coding Form. You may wish to do this if, for example, the Form and Synonym List are configured differently for coding with ATCs.

To unassign a Synonym List from a Form:

1. Locate the Form you want to edit in Coder Tools > Study Settings > Form Configuration.
2. Hover over the Form to display the Actions menu.

3. From the Actions menu, select Edit.

4. In the Edit Form dialog, select the empty field in the Synonym List dropdown.
5. Click Save.
6. Vault unassigns the Synonym List from the Form. Vault will not use any Synonym List to perform autocoding on this Form.

See Form Configuration in Coder Tools for additional details about available form configuration options.

Edit a Synonym List

You can edit your Synonym List to change the Name or Status. Note that you can’t edit the Dictionary Version. You can only change the Dictionary Version of a Synonym List by upversioning it. See details below.

To edit a Synonym List:

1. Locate the Synonym List you want to edit in Coder Tools > Synonym Lists.
2. Hover over the Synonym List to display the Actions menu.

3. From the Actions menu, select Edit. Vault opens the Edit Synonym List dialog.

4. Make your changes.

5. Click Confirm.

Upversioning a Synonym List

To change the Dictionary Version associated with a Synonym List, you must upversion the Synonym List. See Upversioning to a New Dictionary Release for details.

Review & Approve or Reject New Synonyms

Depending on your study’s configuration, you may have to review new Synonyms before they can enter into a Synonym List. When a coder user adds a term as a Synonym, that Synonym enters the Pending Review status. Until you approve the Synonym, Vault does not add it to the Synonym List for use in autocoding and suggestions.

Approving Synonyms

To approve a Synonym:

1. Locate the Synonym List new Synonyms in Coder Tools > Synonym Lists.
2. Click to open the Synonym List.
3. Hover over a Synonym to display the Actions menu.

4. From the Actions menu, select Approve.

5. Vault moves the Synonym into the Approved status. Vault now uses this Synonym to inform autocoding and suggestions.

To approve Synonyms in bulk:

1. Locate the Synonym List new Synonyms in Coder Tools > Synonym Lists.
2. Click to open the Synonym List.

3. Select the checkbox to the left of each Synonym that you want to approve.

4. Optional: To select all Synonyms at once, select the checkbox in the header.
5. Click Approve.

Rejecting & Deleting Synonyms

For any Synonyms that you do not want to add to the Synonym List, you can either reject or delete the Synonyms. If you reject a Synonym, Vault does not use the synonym to inform autocoding, but the Synonym remains on the Synonym List. If you delete a Synonym, Vault does not use it for autocoding and deletes the record entirely.

To reject or delete a Synonym:

1. Locate the Synonym List new Synonyms in Coder Tools > Synonym Lists.
2. Click to open the Synonym List.
3. Hover over a Synonym to display the Actions menu.
4. From the Actions menu, select Reject or Delete.

To reject or delete Synonyms in bulk:

1. Locate the Synonym List new Synonyms in Coder Tools > Synonym Lists.
2. Click to open the Synonym List.
3. Select the checkbox to the left of each Synonym that you want to approve.
4. Optional: To select all Synonyms at once, select the checkbox in the header.
5. From the Approve menu, click the Arrow ().
6. Click Reject or Delete.

Import Synonyms

You can create Synonyms and add them into a Synonym List in bulk using a CSV (.csv) file.

During import, Vault validates each of the Synonyms in your imported CSV file to ensure that all assigned dictionary codes are also available in the dictionary release assigned to the Synonym List.

You can create an import CSV file using these templates:

  Download the WHODrug with ATCs Template   Download the WHODrug without ATCs Template   Download the MedDRA Template

Creating the Import File

1. Download the template and open it in your preferred editor.
2. Add a row for each Synonym you want to add to the Synonym List.
3. Save your file.

Required Columns for WHODrug with ATCs Synonyms

The following columns are required in your import file:

Verbatim Indication1 Route1 Drug Code Drug Name Preferred Code Preferred Name ATC4 Code2

ATC4 Name2 ATC3 Code2 ATC3 Name2 ATC2 Code2 ATC2 Name2 ATC1 Code2 ATC1 Name Status

¹ Leave the Indication and Route columns empty if you are importing for a Synonym List assigned to a Form that doesn’t collect data for Indication or Route.

Required Columns for WHODrug without ATCs Synonyms

The following columns are required in your import file:

Verbatim Indication1 Route1 Drug Code Drug Name Preferred Code Preferred Name Status

¹ Leave the Indication and Route columns empty if you are importing for a Synonym List assigned to a Form that doesn’t collect data for Indication or Route.

Required Columns for MedDRA Synonyms

The following columns are required in your import file:

Verbatim LLT Code LLT Name PT Code PT Name HLT Code HLT Name

HLGT Code HLGT Name SOC Code SOC Name Primary Path1 Status

¹ The Primary Path is available to inform you and other administrators of the nature of each Synonym in the Synonym List. This value only applies to Synonym Lists.

Importing the File

To import the file:

1. Locate the Synonym List you want to import Synonyms into.
2. Hover over the Synonym List to display the Actions menu.

3. From the Actions menu, select Import Synonyms.

4. Either drag and drop your CSV file into the Drag and drop file here area, or click anywhere in the area and browse to and select your import file.

5. Vault uploads the file and validates your new Synonym records. Validation results display in the Preview area. See possible validation errors below.
6. Optional: If your import file contains any validation errors, edit the file to resolve them. Then click Change File to re-upload.
7. Once all of your new Synonym records are ready for import, click Import. Vault begins a job to import and create all of your new Synonym records. Vault sends you an email notification when the job is complete.

Import Statuses

There are three possible statuses for a new Synonym List record as you prepare it for import:

Status	Explanation
Error	There is at least one error on this row. Errors indicate missing or invalid values.
Warning	There is at least one warning on this row. Warnings indicate conflicts with existing Synonym List records.
Ready for Import	This Synonym List record is complete and can be successfully imported into the vault.

Validation Errors

Error	Field or Type	Explanation	Steps to Resolve
{Field} is required	Verbatim	This field is required.	Provide a value for this field and re-upload your import file.
Duplicate Entry	Verbatim	Duplicate entry.	Remove the duplicate entry from your file and re-upload your import file.
Synonym Already Exists	User trying to import a Synonym that already exists	The Synonym already exists on the Synonym List.	No action needed.
{Field Name} exceeded allowed character length	Character count exceeds max allowed in database	Number of characters entered by the user is greater than database column length.	Reduce the number of characters in the indicated field and re-upload your import file.
Code must include an ATC1 code and ATC1 label	Code does not include an ATC1 code or label	The Synonym List is configured to include ATCs and a record in the file does not include a value for ATC1 code and ATC1 label.	Provide an ATC1 code or ATC1 label value for this field and re-upload your import file.
Code must not include any ATC codes or labels	Code includes ATC codes or labels	The Synonym List is configured to not include ATCs and a row in the file includes a value for one or more of the below ATC fields: ATC1 Code ATC1 Label ATC2 Code ATC2 Label ATC3 Code ATC3 Label ATC4 Code ATC4 Label	Remove the ATC field(s) and re-upload your import file.

Export a Synonym List

You can export a Synonym List from your Study into a CSV file. This can be useful for record keeping and allows you to use all or a portion of your original Synonym List for another Synonym List.

1. Locate the Synonym List you want to export.
2. Hover over the Synonym List to display the Actions menu.

3. From the Actions menu, select Export.

4. Vault begins a job to create a CSV of your study’s Synonym List. When finished, Vault sends you an email notification with a link to download the output CSV file.

The Synonym List export includes the same columns as the import file (WHODrug with ATCs, WHODrug without ATCs, and MedDRA).