Step 1: Create an Organization & Study

Studio

Vault Admin

Roles


When preparing to build your study design, you must first create an Organization and a Study. The Organization object record groups Studies within that organization together. A Study object record represents a single study. You’ll need to create a new Study object record for each Study you run in Vault CDMS. Note that your selections within Studio > Settings, including the Signature Definition, are not versioned.

Once you create your Study, you can update various study-level settings related to data collection in your study from Studio > Settings.

Create an Organization

To create a Study, you must first create an Organization. To create an Organization:

  1. Open Studio.
  2. Click + New Organization.
    + New Organization Button

  3. Enter a Name.
    New Organization Dialog

  4. Click OK.

Create a Study

To create a Study within your Organization:

  1. Click into your Organization.
  2. Click + New Study.
    + New Study Button

  3. Enter a Name.
    New Study Dialog

  4. Click OK.
  5. Define any additional details in the Properties panel.

Once you’ve created a Study, a lead data manager must create Study Countries and Study Sites. See Managing a Study in EDC Tools for details.

Study Settings

You can control various settings related to your Study in a single location: Studio > Settings. Settings includes three (3) configuration sections: General, Subject ID Generation, and Signature Definitions.

Studio > Settings sub-tab

How to Edit Study Settings

To edit your study’s settings:

  1. Navigate to your Study in Studio and open the Settings tab.
  2. Click Edit.

    Edit button for Settings

  3. Make your changes.
  4. Click Save.

General Settings

You can define general settings related to data collection in your study from the General section of Studio > Settings.

Setting Controls
Standard Date Format Select a date format to use across the study.
Twelve Hour Time Select Yes to use twelve hour time, and select No to use twenty-four hour time.
Enable Other Specify - Reason for Change Select Yes to enable this feature. When enabled, users can enter a custom Reason for Change.
Enable Other Specify - Intentionally Left Blank Select Yes to enable this feature. When enabled, users can enter a custom reason for Intentionally Left Blank.

Subject ID Generation Settings

Vault automatically creates subject IDs for each Subject. At Casebook creation, Vault adds the subject ID SCR-####, incrementing by one for each Subject at the Site. Once the subject passes screening, Vault updates the subject ID to a new auto-generated ID based on the Subject ID Generation configuration.

Once subjects exist in your Study, you will no longer be able to update these settings.
Setting Description
Subject Id Gen Format Enter the format for Subject IDs in the Study. In the current release, Vault supports including or excluding leading zeroes, padded spaces, and #### to show data type. See details below.
Subject Id Gen Type Select the type of auto-generated Subject ID to use. See details below.
Subject Id Range Start Enter a number at which to start numbering Subject IDs. For example, if you enter “001” here, Vault numbers the first Subject ID in the Study with “001”.
Subject Id Range End Enter a number at which to end numbering Subject IDs. For example, if you enter “9999” here, Vault starts numbering over after subject -9999.

Subject ID Format Tokens

The following tokens are available for use in the Subject ID Gen Format setting:

  • study.name: Name field value for the Study
  • study.protocol: Protocol field value for the Study
  • study.oid: External ID field value for the Study
  • country.name: Name field value for the Study Country of the subject’s Site
  • site.number: Site Number (name__v) field value for the subject’s Site

Use # for system-generated numbers. Surround each section of the subject ID format with curly braces {}.

In a Study with the Subject Id Gen Format set to {site.number-####}-{####}, where a Site Number is “101” and the Subject ID Range Start is “0001”, generates the Subject ID “101-0001”, incrementing the second number by 1 for each new Subject at the Site (101-0002, 101-0003, and so on.)

Subject ID Generation Types

Vault supports the following standard Subject ID generation methods. Contact Veeva Services to discuss other generation methods, such as setting the Subject ID based on your organization’s randomization system.

Type Description
by_site Vault generates unique (at the Site level) Subject IDs based on the template in the Subject ID Gen Format field within the range of the Subject Id Range Start and Subject Id Range End.
manual A data entry user enters the subject ID in a configured data collection Item (a Status-type Item within a Screening_- or Enrolled-type Event).
external Use this method if your organization plans to import Subjects from another system. Contact your Veeva Services representative for details about connecting external systems to Vault CDMS for subject import.

Signature Definitions

In order for your investigators in your Study to provide eSignatures, you must configure a Signature Definition object record related to your Study.

The buttons and actions related to signatures will not display for investigator users until you create a Signature Definition.

In the current release, Vault CDMS only supports a single Signature Definition per Study. Vault disables the + New Signature Definition button once you create a Signature Definition.

Users with the appropriate permissions can also configure Signature Definitions from Admin > Business Admin. See Configuring Signature Definitions in Business Admin for details.

Create a Signature Definition

To create your study’s Signature Definition:

  1. Navigate to your Study in Studio.
  2. Scroll to Settings > Signature Definitions.
  3. Click + New Signature Definition.

    New Signature Definition button

  4. In the Signature Definition dialog:
    • Select a signature Methodology from the drop-down list.
    • Enter a Meaning for signatures in your study.
    • Enter a Legal Reason for signatures in your study.
    • Optional: Enter an External ID for your Signature Definition. Signature Definition dialog
  5. Click Save.
  6. Vault saves your changes and applies them to any future signatures in your Study.

Edit a Signature Definition

You can edit your Signature Definition as needed from Studio > Settings. Editing the Signature Definition when there are already signed forms in your study invalidates all existing signatures. Any signed forms revert to the Completed status. Investigators will have to re-sign all previously signed forms.

To edit your Signature Definition:

  1. Locate your Signature Definition in Settings > Signature Definitions.
  2. From the Actions menu, select Edit.
  3. Make any required changes in the Signature Definition dialog.
  4. Click Save.
  5. Vault saves your changes and applies them to any future signatures in your Study.

Studio

Vault Admin

Roles