It is common industry practice to design blinded studies to avoid introducing bias into study results. When running a blinded study, there are two types of content: blinded and unblinded. Unblinded content contains sensitive study information, for example, randomization, and can only be viewed by a limited group of people to ensure that study teams do not know which subjects are assigned to test groups versus placebo groups. Blinded content is unrestricted and can be viewed by all users without risk of biasing study results.
With the User object or User Role Setup object records, Admins can define which users can create unblinded (restricted) content and which cannot. When users create, classify, or reclassify a document, or update Study, Study Country, or Study Site document field values, Vault automatically sets the Content (blinding__v) document field value according to the type of content they can create, allowing organizations to securely and confidently manage restricted content in Vault.
When users create or update a document, Vault first checks the Blinding value defined at the User Role Setup (URS) record level to determine the default value for the Content document field. If no study-specific URS record exists, Vault sets the Content document field based on the Create Content field defined on the User object. If neither the study-specific URS record nor the User record has a defined value, Vault sets the Content document field based on the default value specified at the Content document field level.
Note: Depending on your Vault’s configuration, the Content document field may be labeled Blinding.
Setup Overview
To enable Vault to automatically populate the Content document field, you’ll need to complete a series of steps:
- Enable the Content Blinding Field Defaulting feature.
- Add the Content (
blinding__v) shared document field to all applicable document types. - Optional: Configure the Change to Blinded user action at any applicable document lifecycle states.
- Set the Blinding value on the study-specific User Role Setup record, the Create Content field on the User object record, or the Content document field.
- Optional: Prevent users from selecting the Send as Link action for restricted content.
Enabling Content Blinding Field Defaulting
To allow Vault to automatically populate the Content (blinding__v) document field for a given user, navigate to Admin > Settings > Application Settings and select the Enable Blinding Document Field Defaulting checkbox.
Note that enabling this feature sets the Content (blinding__v) field to Read Only and Not Required.
Adding the Content Field
Add the shared Content field (blinding__v) to any document types, subtypes, or classifications for which you want Vault to populate the field. Vault automatically sets this field when a user creates, classifies, or reclassifies documents of this type, or updates Study, Study Country, or Site document field values.
You must add the Content (blinding__v) field to the Undefined document type so that users can see the field on Inbox Documents. This will also allow users to manually set this field when they create Inbox Documents if Content field defaulting is disabled in your Vault.
Configuring the Change to Blinded User Action
Unblinded users can create both unblinded (restricted) and blinded (unrestricted) content. Vault automatically sets the Content (blinding__v) document field to Unblinded for documents they create. To allow an unblinded user to update the Content field from Unblinded to Blinded for a given document, you can configure a Change to Blinded user action on the applicable document lifecycle state. To do this:
- Navigate to Admin > Configuration > Document Lifecycles > [Lifecycle] > States > [State] > User Actions and click Edit.
- Click Create Rule.
- In the drop-down, select Change Blinding Field Value From Unblinded To Blinded.
- Enter a Label. We suggest Change to Blinded (Unrestricted).
- Click Save.
Note: Users can access this action only if they have both Blinded and Unblinded values set at the User Role Setup record level or the Create Content field level on their User object. Their document roles must also include the Edit Fields permission to complete the action.
User Configuration Options
There are several user configuration options you can use to define how Vault populates the Content (blinding__v) document field. Note that while Vault populates the Content field, you’ll still need to configure Dynamic Access Control to ensure that Vault shares the content with the correct group of users.
Via User Role Setup & Study Person
You can configure a User Role Setup record to define a user’s ability to create restricted or unrestricted content on a per-study basis. You’ll need to configure the User Role Setup object to include a field of type Picklist that uses the standard Blinding (blinding__v) picklist. Setting this field in the study-specific User Role Setup record sets the Content (blinding__v) document field value when the user creates or updates documents related to that Study, Study Country, or Study Site. You can also use the Study Person object to create User Role Setup records in bulk.
Note that when users create or update a document, Vault first checks the Blinding value defined at the Study Team Role record level. If no Study Team Role record exists, Vault sets the Content field based on the Create Content field on the User object. If neither the Study Team Role record nor the User record has a defined value, Vault sets the Content field based on the default value defined at the Content field level. To define a default value for the Content field, navigate to Admin > Configuration > Document Fields > Content.
Via the User Object
The Create Content (blinding__v) field exists on the User object, allowing Admins to easily manage what type of content a user can create throughout that Vault. Navigate to Admin > Business Admin > Users and select a User record. Click Edit, and choose a value for the Create Content field. The Create Content field references the standard Blinding picklist.
Setting this field to Unblinded allows the user to create restricted content. Vault sets the Content (blinding__v) document field to Unblinded for these users, ensuring that unblinded content stays restricted during study conduct. Setting the Create Content field to Blinded only allows a user to create unrestricted content. Vault sets the Content (blinding__v) field to Blinded for these users.
Setting the Create Content field to both Blinded and Unblinded allows the user to create both unrestricted and restricted content. The Content document field will first default to Unblinded. The user can switch the Content (blinding__v) field to Blinded by selecting the Change to Blinded option from the document Actions menu.
Note that if a study-specific User Role Setup record exists, the Create Content field on the User object is ignored, and the Blinding value in the User Role Setup will determine the default value for the Content document field for that study.
Via the Content Field
To define a default value for the Content field, navigate to Admin > Configuration > Document Fields > Content.
Content Field Defaulting & Requiredness Behavior for the Document Inbox
This table lists the effects of configuration options for content field defaulting in the Document Inbox:
| Content Field Defaulting | Content Field Requiredness | Classify Later Behavior | Drag & Drop Behavior | Veeva Snap/API Behavior |
|---|---|---|---|---|
| Enabled | Required OR Optional | Vault does not display the Content field, and defaults the value based on Content Defaulting rules. | No Content field displayed in the bulk apply fields dialog. Content field defaulted based on Content Defaulting rules. | Content field defaulted based on Content Defaulting rules. |
| Disabled | Required | Vault displays the Content field and it is required before uploading. | Vault displays the Content field in the bulk apply fields dialog with the vault’s default value, if applicable, and is required before uploading. Users cannot hide the bulk apply fields dialog upload status pop-up. | Vault defaults the Content field if there is a configured default. Otherwise, the Content field value is blank. |
| Disabled | Optional | Vault displays the Content field and the field is not required before uploading. | Vault displays the Content field with the vault’s default value, if applicable, and the field is not required before uploading. | Vault defaults the Content field if there is a configured default. Otherwise, the Content field value is blank. |