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 Create Content field on the User object and the Blinding standard picklist, Admins can define which users can create unblinded (restricted) content and which cannot, allowing organizations to securely and confidently manage restricted content in Vault. When you create or classify a document, Vault automatically sets the Content (blinding__v) document field.
Note: Depending on your Vault’s configuration, the Content document field may appear as Blinding.
About Content Field Defaulting
When configured, Vault automatically populates the Content (blinding__v) document field when you create or classify a document.
For Vaults with only the Enable Blinding Document Field Defaulting setting enabled, Vault defaults the Content field on documents to Blinded unless the user who uploaded the document has a User record with the Unblinded value for the Create Content field.
For Vaults with both the Enable Blinding Document Field Defaulting and Enable Enhanced Blinding Defaulting settings enabled, Vault defaults the Content field on documents to Blinded unless the document meets all of the following criteria:
- The Study record’s Masking field value is not Open-Label.
- The document’s Document Type includes the Document Type Groups value of Allow Unblinded.
- The user who uploaded the document has a User record with the Unblinded value for the Create Content field.
Note: Vault does not update the defaulted Content field value when you reclassify the document. Vault also does not override the defaulted Content field when you create the document via API or with a Vault Connection if the source document has a Content field value.
Creating Blinded & Unblinded Content
Based on your user configuration, Vault automatically sets the Content document field to Blinded if you can only create blinded, unrestricted content that poses no risk to study results. If you can create unblinded content, Vault sets the Content (blinding__v) field to Unblinded, ensuring that documents are only available to a small group of users.
Depending on the configuration of your Vault, you may be prompted to set the Content field when you create Inbox Documents.
Switching from Unblinded to Blinded Content
When configured, users who can create unblinded content can sometimes update the Content (blinding__v) document field via a user action. When the Create Content field is set to Unblinded for a document in a given lifecycle state, you can select the Change to Blinded user action from the document Actions menu. This sets the Content (blinding__v) field to Blinded, making the content available to all defined users. Your document role must include the Edit Fields permission to run this action.
Note that setting this field from Unblinded to Blinded cannot be undone.