Creating Sites

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

Prerequisites

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
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, Study Country, or Closeout Status. Select a value from the filter menu to filter by it. You can search for individual values to filter by. To remove a filter, click Clear All in the filter menu.

Filter by Study Country is United States

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. This opens the New Site dialog. New Site Button

  3. Enter a Site Number. New Site Dialog

  4. Enter a Site Name.
  5. Select a Status.
  6. Select a Study Country. If the Study Country doesn’t exist:
    1. Select + Create New Study Country.
    2. In the Manage Study Countries dialog, use the shuttle menu to move Countries into the Study Countries panel.
    3. Click Save.
    4. Select a Study Country if not already selected.
  7. Select a Principal Investigator. If the Principal Investigator doesn’t exist:
    1. Select + Create New Principal Investigator.
    2. Enter the user’s First Name and Last Name.
    3. Click Save.
  8. Select a Timezone.
  9. Select an Active Version.
  10. 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.

How to Delete a Site

  1. Navigate to Tools > EDC Tools.
  2. Choose your Study and environment and navigate to the Sites tab.
  3. Hover over the Site Number and click the Actions Menu. Click Delete.

Deleting Sites

If you need to delete a site in a Production environment, you can do so in EDC Tools if there are no subjects in that site.

Deploying to Sites

Once a study designer publishes the initial version of your Casebook Definition, you can assign that to your Sites via the site’s Active Version field.

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. You can use an amendment to update existing Casebooks to the new version.

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

  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.

File Restrictions

  • CSV file must be smaller than 100mb.
  • Use CSV UTF-8 encoding, or don’t use any special characters.

Required Columns

The following columns are required in your file:

Column Description
Site Number

Enter your site’s Site Number. The Site Number displays in all site listings.

If a Site Number contains a leading zero, for example, 0101, you must format the column in the CSV file as text before saving the file. Then, you must upload without reopening the file again. Reopening clears any formatting from the CSV, which removes the leading zeros.

Site Name

Enter your site’s Site Name.

Site Status

Enter one of othe 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 for your Study from EDC Tools > Study Countries. If a Study Country doesn’t exist for the site’s country, enter the Country, and Vault will automatically create the Study Country record upon import.

Principal Investigator

Enter your site’s Principal Investigator (using Firstname Lastname format). Any Principal Investigators must already exist in the Study. If non exist, you must add them before importing Sites by either creating a Site manually or updating their User records from Tools > System Tools > Users.

Timezone

Enter your site’s Timezone. See a list of timezone entry formats here.

Active Version

Enter the Name of the Active Version to assign to this Site. You can see a list of Active Versions from EDC Tools > Casebook Versions > All Versions. Use the value in the Name column. Any Casebooks created in the Site use the Active Version.

Required Columns: Note that all columns in the table above are required for successful import. They must be included in the CSV file and each row must have a value for each column.

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, 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

The table below lists possible validation errors and their resolutions:

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

Your import file contains duplicate Site rows, based on the Site Number.

Edit your file and either update the Site Number or remove the duplicate row.

Invalid Site Status Site Status

Your import file lists an invalid Site Status value.

Edit your file and enter one of the valid Site Statuses, listed in the tablle above. These are the only allowed values.

Invalid Principal Investigator Principal Investigator

The Principal Investigator provided doesn’t match an existing Principal Investigator (record in the Person object, person__v).

Edit your file and enter a different Principal Investigator, or create the Principal Investigator by editing that User.

Version[version] does not exist Active Version

The Active Version you provided doesn’t match the Name of any Active Versions for the Study.

Edit your file and update the Active Version to an existing version. You can see a list of version Names from EDC Tools > Casebook Versions > All Versions.

[Field] is required All

This field is required.

Edit your file and provide a value for the required column.