Managing Lab Locations & Normal Ranges

In the Lab Settings section of the Labs tab, you can view approved and pending Lab Locations, add new Lab Locations, import Lab Locations, add Normal Ranges, and Import Normal Ranges. You can also run lab-specific jobs.

Viewing Lab Locations & Normal Ranges

In the Lab Locations & Normal Ranges tab, Vault displays tables of all approved and pending Lab Locations (statuses split into two subtabs) with Lab IDs, Status, and whether the location is In Use. The Pending Locations subtab label includes the number of Lab Locations that are in the Pending status and lists Lab Locations that aren’t approved yet.

To view the Normal Ranges associated with a Lab Location, click the Lab ID in the location table. From the Normal Ranges page, you can add new Normal Ranges, edit existing Normal Ranges, export the ranges for that locations, or view the audit history for the location.

Lab Locations and Normal Ranges tab

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

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. If you want to edit columns in the Normal Ranges table, click the Lab ID of a Location to open the Normal Ranges table for that location. To edit columns for the Lab Locations table, remain on this page.
  3. From the Actions menu, select Edit Columns.
  4. Use the shuttle menu to move columns from Available Columns to Selected Columns. The columns under Selected Columns display in the table.
  5. Click Save.

Action Menu for the Lab Locations tab

Lab Locations

You can add Lab Locations one-by-one, or you can import Lab Locations in bulk using a CSV file.

Add Individual Lab Locations

To add a new Lab location:

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. Click + New Lab.
  3. Fill all required and relevant fields.
    • Initiated By Study: This field shows which Study the Lab Location was initiated for. The dropdown list will only show studies that you have permission to access and that have Labs enabled.
    • Initiated By Site: This field shows which Site initiated the Lab Location. The dropdown list will only show sites that you have permission to access.
  4. Click Save.

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

Lab Locations Action Menu

Import Lab Locations

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.

File Size Limit: Your import CSV file can’t exceed 100MB in size.

To import:

  1. Navigate to Lab Tools > Lab Locations & Normal Ranges.
  2. Click Import Lab Locations.
  3. Drag and drop your completed template to upload, or click in the upload area to browse for the file.
  4. Click Import.

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 managers. Lab Locations that are entered in the Labs module are automatically approved.

Lab Locations

Last Updated: 21R3

This video provides instructions on how to add Lab Locations in the Labs module.

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. (MM/DD/YYYY hh:mm AM/PM Timezone)
  1. Navigate to Lab Tools > Lab Locations & Normal Ranges.
  2. Click Import Normal Ranges.
  3. Drag and drop your completed template to upload, or click in the upload area to browse for the file.
  4. Click Import.

To view an example template of a completed Lab Normal Import file, refer to the template below:

  Download a completed example template

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.

Deactivate a Normal Range

Vault doesn’t allow you to delete Normal Ranges for existing Lab Locations. However, you can change the Status of a Normal Range to _Inactive.

To deactivate a Normal Range:

  1. Navigate to Labs > Lab Locations & Normal Ranges.
  2. Locate the Lab Location containing the Normal Range that you want to deactivate.
  3. Click the Lab ID to open Normal Ranges for that _Lab Location.
  4. Click Edit Normal Ranges.
  5. Locate the row for the Normal Range you want to deactivate.
  6. In that row, select Inactive for Status.
  7. Click Done.

If a Normal Range is missing the Measurement Unit, Vault automatically assigns that range the Incomplete status.

Normal Ranges

Last Updated: 21R3

This video provides instructions on how load Normal Ranges in the Labs Module.

Approving Normal Ranges

If approval is enabled in System General Settings > General Settings, Normal Ranges must have the Active status to be used in a Lab form. 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.

Reports Mass Updates

You can perform jobs specific to the Labs module from Labs > Reports Mass Updates. 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 > Reports Mass Updates.
  2. Click New Job.
  3. Select a Type for the job. Mass Updates dialog

  4. Select the Study that you want to run the job in.
  5. Click Run Job. Vault begins the job. When finished, Vault sends you an email notification with a link to download the job log and any relevant output files.

Updating Lab Locations & Outdated Normals: You must run the Update New Lab Locations job before running the Update Outdated Lab Normals job in order to update Lab Locations and normal ranges effectively.

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 ID, Lab Title, 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.