Creating Sites

Lead Data Managers can now manage their Sites from the EDC Tools area of Vault EDC. In the Sites tab, study administrators can create new Sites for site personnel to use when conducting the Study.

Prerequisites

Site closeout functionality is only available in vaults where the Role by Study feature is enabled. Contact Veeva Support to enable Role by Study in your vault.


Users with the standard CDMS Lead Data Manager application role and a Security Profile that grants access to the EDC Tools can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab

Functional Permission Manage Study Sites

Ability to create and edit Sites from EDC Tools

Functional Permission Manage Study Lock

Ability to lock and unlock Studies and Sites from EDC Tools

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


Viewing Study Sites

To view all the sites in your Study, open the EDC Tools tab in your vault, and then open the Sites tab. In this tab, you can view a list of all the Study Site records associated with your Study that you have permission to view, with columns for site details (fields on the Study Site object).

Sites Tab in EDC Tools

You can click on a column to sort by that column. You cannot sort by the Subjects or Users column.

You can also filter your sites by Status and Country. Select a value from the Status or Country drop-down menu to filter by it.

Site Details

You can view additional details about a site by clicking the Site Number, which opens the Edit Study Site dialog. 

How to Create a New Site

To create a new Site:

  1. From EDC Tools, open the Sites tab.
  2. Click New Site.
    New Site Button

  3. Fill the required fields. Study countries and Active Versions can also be added during this step.
    New Site Dialog

  4. Click Save.

How to Edit a Site

  1. Click the Site Number for the site you want to edit.
  2. Make any changes.
  3. Click Save.

Deploying to Sites

Once a clinical programmer has published the initial version of your Casebook Definition, and, if applicable, imported it from a development to production vault, Vault automatically assigns the most recent, published version available to newly created sites.

For example, if you created two sites in January 2019, when there was only one published version of your study, those sites were automatically assigned to that first version. Since then, there were two more versions added to your study. When you create a new site, Vault automatically assigns the new site to the most recent version, Version 3.

As you add new versions to your Study, you will need to update the Active Version of your Sites. The Active Version is the version that Vault uses to create new Casebooks at that Site.

Update a Site’s Active Version

To update the Active Version of a single Site:

  1. Navigate to your Study in EDC Tools.
  2. Open Sites.
  3. Click the Site Number of the Site you want to update. Vault opens the Edit Study Site dialog.
  4. Select a new Active Version from the drop-down.
  5. Click Save.

You can now run an amendment to update existing Casebooks at the site or subject level to the new casebook version.

Update the Active Version for Multiple Sites

To update the Active Version of multiple Sites:

  1. Navigate to your Study in EDC Tools.
  2. Open Sites.
  3. Select Sites to update. Selected Sites

  4. Optional: Select the *All Sites** checkbox in the header to select all Sites.
  5. Click Set Active Version. Vault opens the Set Active Version dialog. Set Active Version button

  6. Select an Active Version from the drop-down. Set Active Version dialog

  7. Click Set Active Version. Set Active Version confirmation button

  8. Vault updates the Active Version for all selected Sites. From this point forward, all Casebooks created within these Sites will be based on the assigned Active Version.

You can now run an amendment to update existing Casebooks at the site or subject level to the new casebook version.

Importing Sites

You can also create new Sites in your Study in bulk by importing them as Site records from a CSV (.csv) file.

Creating the Import File

You can create an import file using this template:

  Download the Template CSV

Note that your import CSV must be smaller than 100mb.

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

Required Columns

The following columns are required in your file:

Column Details
Site Number Enter your site's Site Number.
Site Name Enter your site's Site Name.
Site Status

Enter one of the following Site Statuses for your site:

  • Qualifying
  • Initiating
  • Active
  • Closed
  • Enrollment Complete
  • Terminated
  • Withdrew
  • Did Not Participate
Study Country

Enter your site's Study Country. You can view a list of Study Countries in your Study from EDC Tools > Study Countries.

You can also choose to enter a Country name, and Vault can automatically create the appropriate Study Country record upon import.

Principal Investigator Enter your site's Principal Investigator (using the Firstname Lastname format).
Timezone Enter your site's Timezone. See a list of timezone entry formats here.

Importing the File

To import the file:

  1. Navigate to EDC Tools > Sites.
  2. Click Import from File.

    Import from File button in EDC Tools > Sites

  3. Click in the Drag and drop file here area to select a file (or drag and drop a file and skip to step 5). Drag and drop file here for Importing study sites

  4. Browse to and select your file.
  5. Vault uploads the file and validates your new Site 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 Site records are ready for import, click Import. Vault begins a job to import and create all of your new Site records. Vault sends you an email notification when the job is complete.
  8. Click Job History or Back to Study.

Import Statuses

There are three possible statuses for a new Site 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 Site records.
Ready for Import This Site record is complete and can be successfully imported into the vault.

Validation Errors

Error Field Explanation Steps to Resolve
Site already exists Site Number This Site already exists in your Study (based on the Site Number). Edit your file and either update the Site Number or remove the existing Site row.
Duplicate Site record Site Number, Site Name Your import file contains duplicate sites or a Site that already exists in your vault (based on the Site Number). Edit your file and either update the Site Number or remove the existing Site row.
Invalid Site Status Site Status Your import file lists an invalid Site Status value. Edit your file and enter one of the Site Status values listed here. These are the only allowed values.
Invalid Principal Investigator Principal Investigator The Principal Investigator provided must match a record on the Person object (person__v). Edit your file and enter a different Principal Investigator, or create a Person record for this investigator.
{Field Name} is required All This field is required. Edit your file and provide a value for the required column.