Study General Settings for Labs

In the Study General Settings section, you can configure Clinical Significance and Out-of-range Query Settings. Study Settings are inherited from the System General Settings tab.

Configure your study’s general settings before creating a Lab Panel, as Vault locks these settings once a Lab Panel is created.

Study Settings

You can control the following study-level settings from Labs > Study General Settings:

  • Fire Out-of-range Queries by Default
  • Allow Site Overrides for Lab Normals
  • Default Day and Month for Age Calculations
  • Disable Unit Selection for Lab Results when Lab Normals are Present
  • Enable Clinical Significance

To edit study settings:

  1. Navigate to Labs > Study General Settings.
  2. Click your Study to open it, or click Select Study and select your Study in the breadcrumb menu.
  3. Click Edit.
  4. Make your changes.
  5. Click Save.

Study General Settings

General Settings

Enable Pending Lab Locations

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

Allow Site Overrides for Lab Normals

The Labs module supports the ability of sites to override the normal range if the current range is inaccurate or doesn’t exist.

Setting Default Description
Yes   Site users can override the Normal Range for a Lab Result using the Normal Override column in Data Entry.
No When set to No, Vault doesn’t allow site users to override the normal range.

Default Day and Month for Age Calculations

Select a Day and Month to use as the default value when calculating Age and the birth date contains unknowns.

Disable Unit Selection for Lab Results when Lab Normals are Present

This setting controls whether or not site users are able to change the Unit for a Lab Result when there are Lab Normals.

Setting Default Description
Yes   When set to Yes, Sites are not able to change the Unit for a Lab Result when Lab Normals are present.
No When set to No, sites are able to change the Unit for a Lab Result when Lab Normals are present.

Query Settings

Fire Out-of-Range Queries by Default

Setting Default Description
Yes When set to Yes, Vault automatically opens a query when the value is out of range. If clinical significance is also enabled, Vault will signify whether the out-of-range result is clinically significance. Vault defaults Clinical Significance to Yes if it is undefined.
No   Vault doesn’t automatically open a query on an out-of-range result value.

Certain queries will be automatically generated by Vault. Please refer to the table below for more details.

Query System Behavior
Out of Range If a Lab result is out of range, Vault will generate a query if Out of Range queries are configured in the Study Settings.
Missing Labs Result If a Site doesn't enter a Lab result, Vault will generate a query.
Missing Clinical Significance If clinical significance is enabled for the study and a lab result is out of range, the clinical significance field will appear. If the Site doesn't select clinical significance, a system query will generate.
Age If you enter an age that's different from the age that has been calculated by the system, Vault will generate a query.
Unit Discrepancy If the Site changes the Unit that was automatically populated with the selected Lab Location, Vault will generate a query.

Site Lab Assignment

In the Site Lab Assignment section, you can manage the Lab Locations available for each Site in your Study.

Assign a Lab Location

To assign a Lab Location to a Site:

  1. Navigate to Labs > Site Lab Assignment.
  2. Click your Study to open it, or click Select Study and select your Study in the breadcrumb menu.
  3. Click the Site Number of the site you want to edit.
  4. Click Add Lab Location.

  5. Select the Labs that you want to add using the selection checkboxes.
  6. Click Continue.

Delete (Unassign) a Lab Location

To delete, or unassign, a Lab Assignment from a Site:

  1. Navigate to Labs > Site Lab Assignment.
  2. Click your Study to open it, or click Select Study and select your Study in the breadcrumb menu.
  3. Click the Site Number of the site you want to edit.
  4. Hover over the Lab ID to show the Delete button ().
  5. Click Delete ().

  6. In the Delete Lab confirmation dialog, click Continue.

This deletes the Lab Assignment. It doesn’t delete the Lab Location. You can still assign the location to other Sites in your Study, or reassign it to the current Site.