Managing Analytes, Units, & Codelists

The System Settings section of the Labs module includes the Analyte Library and General System Settings, where you can add and edit Units, Codelists, and configure general settings.

Analyte Library

The Analyte Library is a collection of Analytes that you can use to map your lab’s Normal Ranges. From the Analyte Library tab, you can add, edit, copy, import, and delete analytes.

To edit the Analyte Library columns, export your library, or view an Audit Trail, select the gear icon to the right of the library table.

Add Analytes

To add Analytes:

  1. Navigate to Labs > System Settings > Analyte Library.

  2. Click Edit Analytes.

  3. Click Add New Analyte.
  4. Enter a Name in the Analyte column.
  5. Enter a Label.
  6. Select the analyte’s Data Type.
  7. Select the Measurement Type.
  8. If applicable, select a Codelist.
  9. Repeat steps 3 through 8 for additional Analytes.
  10. When finished, click Done.

Edit Analytes

To edit Analytes:

  1. Navigate to Labs > System Settings > Analyte Library.

  2. Click Edit Analytes.

  3. Click on the Cell you want to edit in the library table.
  4. Enter or select the updated value.
  5. When finished, click Done.

You must perform a Vault deployment after making any changes before the changes will be visible in TST and PRD environments. Learn more about making changes Post Go Live here.

Delete an Analyte

You can delete an analyte if it isn’t In Use.

To delete an analyte:

  1. Navigate to Labs > System Settings > Analyte Library.
  2. Locate the Analyte that you want to delete in the list.
  3. Hover over the Analyte to show the Actions menu.
  4. From the Actions menu (), select Delete.
  5. In the Delete Analyte confirmation dialog, click Delete.

Delete an Analyte

You must perform a Vault deployment after making any changes before the changes will be visible in TST and PRD environments. Learn more about making changes Post Go Live here.

Import Analytes

You can import Analytes using this template:

  Download the Analyte Import Template

Case Sensitivity: The Specimen and Testing Method columns are case-sensitive when importing.

Required Columns

The following columns are required in your import file:

Column Details
Analyte Enter the name of the analyte.
Label Enter the analyte label.
Data Type Options Enter Unit, Codelist, Text, and/or Number. If Unit and/or Codelist is selected, you must fill out the Measurement Type and Codelist columns, respectively.
Measurement Type Enter the measurement type. You must have Units configured in System General Settings and your entry must exactly match the Unit Name. This column is required if the Unit data type is selected.
Codelist Enter the codelist name. You must have Units configured in System General Settings and your entry must exactly match the Codelist Name. This column is required if the Codelist data type is selected.
Length Enter the number of digits allowed to the left of the decimal places for normal ranges.
Precision Enter the number of digits allowed to the right of the decimal places for normal ranges.

Any columns not mentioned above are not required for import.

Validation Errors

The table below lists possible validation errors and their resolutions:

Error Explanation Steps to Resolve
Field is required or field must not be empty This field is required. Provide a value for this field.
Name you are trying to add already exists Unit/Codelist name already exists. Enter a different name.
Duplicate Analyte Analyte name already exists. Enter a different analyte name.
Measurement Type is required Measurement type is required when the Unit data type is selected. Enter measurement type.
Codelist is required Codelist is required when the Codelist data type is selected. Enter a codelist.

Lab Modifiers

Lab Modifiers allow Sites to use >, <, ≤, and ≥ when entering lab results to allow for results that are above or below the level of detection.

To configure Lab Modifiers:

  1. Navigate to Labs > Analyte Library.
  2. Click the gear icon to the top left of the library table and select Edit Columns.
  3. Add the Lab Modifier column and click Save.
  4. Click Edit Analytes and click inside the Lab Modifier column for the analyte that you’d like to allow modifiers for.
  5. Select the checkbox and click Done.

In Use Analytes

Once an Analyte is added to a Lab Panel in Studio, or if a Lab Location is using the Analyte, Vault marks the Analyte as In Use. Edits are restricted for In Use analytes and deletion isn’t allowed.

Once an Analyte is In Use, you can no longer update the following properties:

  • Analyte Name
  • Data Type
  • Measurement Type
  • Length
  • Precision

Note that you can increase Precision and Length in DEV environments when an Analyte is In Use.

You can still make changes to the following properties:

  • Labels
  • SDTM Code
  • LOINC Code
  • Testing Method
  • Specimen Type

You must perform a Vault deployment after making any changes before the changes will be visible in TST and PRD environments. Learn more about making changes Post Go Live here.

Units

In the System General Settings tab, you can add Units and Codelists to use within your Labs configuration.

Changes to Precision: If your Study was created prior to 22R2 and isn’t using Versionless Labs, Vault will lock the Precision property after you save your Unit. To edit this property, you must make your changes in Studio.

To add a Unit:

  1. Navigate to Labs > System General Settings > Units.
  2. Click + New Unit.
  3. Fill the required fields.
  4. Create Unit Items by filling the required fields and clicking + Add Unit Item to add additional rows.
  5. Select the Standard radio button on the Unit Item that you want to use by default. Be sure to fill in the Unit Conversion field if applicable. See Defining Default Units & Conversions for more information on unit conversion formulas.
  6. Click Save.

To edit a Unit:

  1. Navigate to Labs > System General Settings > Units.
  2. Locate the Unit that you want to edit in the list.
  3. Click the unit’s Name to open it.
  4. In the Edit Unit dialog, make your changes.
  5. When finished, click Save.

To add or remove a Unit Item:

  1. Navigate to Labs > System General Settings > Units.
  2. Locate the Unit that you want to edit in the list.
  3. Click the unit’s Name to open it.
  4. To add a Unit Item:
    1. Click + Add Unit Item.
    2. Fill in the required fields.
  5. To remove a Unit Item, click Remove ().
  6. When finished, click Save.

To delete a Unit:

  1. Navigate to Labs > System General Settings > Units.
  2. Locate the Unit that you want to delete in the list.
  3. Hover over the unit to show the Actions menu.

  4. From the Actions menu (), select Delete.

  5. In the Delete Unit confirmation dialog, click Continue.

To export a list of Units as an Excel™ file:

  1. Navigate to Labs > System General Settings > Units.

  2. From the Actions menu (), select Export.

  3. In the Export dialog, click Close.
  4. Vault sends an email notification when your file is ready for download.

Codelists

To add a Codelist:

  1. Navigate to Labs > System General Settings > Codelists.
  2. Click + New Codelist.
  3. Fill the required fields.
  4. Create Codelist Items by filling the required fields and clicking + Add Codelist Item to add additional rows.
  5. Click Save.

To edit a Codelist:

  1. Navigate to Labs > System General Settings > Codelists.
  2. Locate the Codelist that you want to edit in the list.
  3. Click the codelist’s Name to open it.
  4. In the Edit Codelist dialog, make your changes.
  5. When finished, click Save.

To add or remove a Codelist Item:

  1. Navigate to Labs > System General Settings > Codelists.
  2. Locate the Codelist that you want to edit in the list.
  3. Click the codelist’s Name to open it.
  4. To add a Codelist Item:
    1. Click + Add Codelist Item.
    2. Fill the required fields.
  5. To remove a Codelist Item, click Remove ().
  6. When finished, click Save.

To delete a Codelist:

  1. Navigate to Labs > System General Settings > Codelists.
  2. Locate the Codelist that you want to delete in the list.
  3. Hover over the codelist to show the Actions menu.

  4. From the Actions menu (), select Delete.

  5. In the Delete Codelist confirmation dialog, click Continue.

To export a list of Codelists as an Excel™ file:

  1. Navigate to Labs > System General Settings > Codelists.

  2. From the Actions menu (), select Export.

  3. In the Export dialog, click Close.
  4. Vault sends an email notification when your file is ready for download.

System General Settings

The General Settings subtab allows you to configure Site Overrides and approvals for Lab Normals and Query Settings, as well as the option to create a Clinical Significance codelist. Click Edit at the top right of the page to edit these settings.

To add a Codelist Item to your Clinical Significance codelist, click Edit and select Add Codelist Item at the bottom of the page. See below for more information about current settings.

Enable Approvals for Lab Normals

Setting Default Description
Yes   When set to Yes, Sites must approve Lab Normals in Data Entry.
No When set to No, Vault doesn’t require Sites to approve Lab Normals.

Allow Site Overrides for Lab Normals

Setting Default Description
Yes When set to Yes, Sites can update Lab Normals in Data Entry.
No   When set to No, Vault doesn’t allow Sites to update Lab Normals.

Enable Pending Lab Locations

Setting Default Description
Yes When set to Yes, Sites can add Lab Locations in Data Entry. These locations will display as Pending in the Labs tab.
No   When set to No, Vault doesn’t allow Sites to add Lab Locations in Data Entry.

Enable Lab Normal Entry in Form

Setting Default Description
Yes   When set to Yes, Sites can enter Lab Normals on a Lab form when the Lab has a Pending Lab Location.
No When set to No, Vault doesn’t allow Sites to enter Lab Normals on a Lab form when the Lab has a Pending Lab Location .

Disable Unit Selection for Lab Results when Lab Normals are Present

Setting Default Description
Yes   When set to Yes, Sites can’t edit Lab result Units in Data Entry.
No When set to No, Vault allows Sites to edit Units .

Importing and Exporting Translation Files

You can upload translated Codelists, Units, and Analytes in the Language & Region tab. Note that you must have the View All Lab Settings permission to view this tab and export files and the Manage Lab Study Settings permission to view, export, and import files. See Standard CDMS Study Roles for more information about roles and permissions.

Importing files with Chinese characters: You must use the CSV UTF-8 file format when importing translation files with Chinese characters.

Translation outcomes vary between Global and Study-level labs and are dependent on which user is adding a lab panel. Refer to the table below as an example for the various outcomes available when the Spanish language is imported.

  Global Version Study-level Version
  Studio EDC (logged in as Spanish user) Studio EDC (logged in as Spanish user)
English User Adds New Lab Panel Analytes/Units/Codelists are in English Analytes/Units/Codelists are in Spanish Analytes/Units/Codelists are in English Analytes in Spanish, Units/Codelists in English*
Spanish User Adds New Lab Panel Analytes/Units/Codelists are in Spanish Analytes/Units/Codelists are in Spanish Analytes/Units/Codelists are in Spanish Analytes/Units/Codelists are in Spanish

*You must manually add translation for units and codelists in Studio to appear in EDC.