Viewing and Editing Lab Locations and Normal Ranges

In the Lab Settings section, you can add new Labs, import Lab Locations and Normal Ranges, and view approved and pending lab locations.

Lab Locations & Normal Ranges

The Lab Locations & Normal Ranges tab displays a table containing all approved Lab locations along with Lab IDs, statuses, and whether or not that location is In Use. The Pending Locations subtab displays a number indicating how many Lab locations are pending and contains Lab locations that haven’t been approved yet. Clicking on a Lab name in the Approved Locations table will direct you to that Lab’s normal ranges where you can add new Normal Ranges, edit existing ranges, export all ranges for that location, or export that location’s audit trail.

Lab Locations and Normal Ranges tab

Lab Locations

To add a new Lab location:

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. Click + New Lab.
  3. Fill out required fields and click Save.

Select the gear icon next to the Lab ID for more options.

Lab Locations Action Menu

You can import Lab Locations using this template:

  Download the Lab Location Template

The following columns are required in your file:

Column Details
Lab ID Enter the Lab ID(s) associated with your lab location(s).
Lab Name Enter the name of the lab location.
Lab Address Enter the address of the lab location.
Country Enter the country where the lab location is located.

To import:

  1. Click Import Lab Locations in the Lab Locations & Normal Ranges tab.
  2. Drag and drop your completed template to upload.
  3. Click Import.

Note: Your file cannot exceed 100MB in size.

Pending Lab Locations

If a Site enters a Lab Location in the Data Entry tab, that location will be given a “Pending” status, meaning that it must be approved by a Data Manager or Lab Manager. Lab Locations that are entered in the Labs module will be automatically approved.

Normal Ranges

You can manually add, upload, or edit local lab Normal Ranges for analytes collected in EDC in Lab Settings > Lab Locations & Normal Ranges. Normal Ranges only need to be entered once and can be leveraged elsewhere in your study once entered. When testing methods are being changed, you can update effective Begin dates in this section. You can configure queries to automatically generate for abnormal ranges in the Study General Settings tab of the Labs module.

You can import Normal Ranges using this template:

  Download the Lab Normal Ranges Template

The following columns are required in your file:

Column Details
Lab ID Enter the Lab ID(s) associated with your normals.
Analyte Enter the Analyte(s) associated with your normals.
Lower Normal Enter the Normal Range low.
Upper Normal Enter the Normal Range high.
Measurement Unit Enter the measurement unit associated with your normals.
Effective From Date Enter the effective start date of your normals.

Adding Normal Ranges

You can manually add Normal Ranges in addition to or instead of uploading them via the template above.

To manually add Normal Ranges:

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. From the Lab Locations table, click the Lab ID for which you’d like to upload or edit ranges.
  3. To add a new range, click + New Normal Range.
  4. From this point, you can begin filling in the table with your data. When finished, click Done to save your changes.

Normal Ranges can’t be deleted for existing Lab locations but ranges can be changed to Inactive in the Labs module. To change a Normal Range status to Inactive, navigate to Lab Locations & Normal Ranges and select a Lab. Click Edit Normal Ranges and click on the Status column to change the status. Click Done. If you’re missing a measurement unit, Vault will automatically set your Normal Range status to Incomplete.

Approving Normal Ranges

If approval is enabled in System General Settings > General Settings, Normal Ranges must have an Active status to be used in a Lab form. To view the status of your Normal Ranges, you must add the Status column in the Lab Locations & Normal Ranges tab. Refer to the table below for more information about Normal Range statuses.

Status Description
Pending Approval Normal range is waiting for approval. Normals won't load in the eCRF until they've been approved.
Incomplete Normal range is missing units.
Active Normal range is approved.

To add or remove columns in your Lab Locations & Normal Ranges tables:

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. Select a Lab Location to view normal ranges for that location.
  3. Click the Actions menu in the top right of the table and select Edit Columns.
  4. Choose columns to add from the Available Columns box and choose columns to remove from the Selected Columns box.
  5. Click Save.

Action Menu for the Lab Locations tab

Mass Updates

You can perform jobs specific to the Labs module in the Mass Updates tab. For more information on the types of jobs available in this tab, refer to the table below.

To run a job:

  1. Navigate to Labs > Mass Updates.
  2. Click New Job at the top of the table.
  3. Select the Job Type from the dropdown menu. Mass Updates dialog

  4. Select the study that you’d like to run the job in, if applicable.

Job Description
Preview of Lab Locations Report This report will show all Pending Lab Locations that have been merged or approved and that will get updated to the New Lab Location once the Updating Lab Location job is completed. This report includes the following columns: Study, Site, Subject, Event Group Label, Event Group Sequence Number, Event Label, Form Label, Form Sequence Number, Lab Name, Lab Address, Lab Country.
Update New Lab Locations After this job is run, forms with a “Pending Lab Location” status will have an approved/merged Lab Location status. This job also updates Lab IDs and data in Lab Forms (normals, queries, rules, and clinical significance). Note that Locked and Frozen items will not be updated.
Outdated Normals Report This report shows all the Site Normals that do not match the normals in the Analyte library. Normals might not match due to a new effective date, Data Entry error, or normals not being updated in a timely manner. This report includes the following columns: Study, Site, Subject, Event Group label, Event Group Sequence Number, Event label, Form label, Form Sequence number, Lab Panel (Item group label), Analyte definition label, Normal Low, Normal High, Expected Normal Low, Expected Normal High, Codelist Normal, Expected Codelist Normal, Text Normal, Expected Text Normal.
Update Outdated Lab Normals This job will update a study's outdated normal values. Errors will appear for any unsuccessful updates. The Item Audit trail will show updates of Lab normals. Note that Frozen and Locked Items will not be updated.
Override Normals Report This report gives Data Managers the opportunity to review Override normals entered by Sites and update the Normal Ranges library if necessary.