Vault can automatically assign a Blinded/Unblinded content value to CTMS objects when the Enable CTMS Content Field Defaulting setting is enabled. 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 a risk of biasing study results.
Content Field Defaulting in CTMS can support Unblinded Monitoring activities where unblinded monitors are required to complete site visits and review data that is restricted from blinded study team members.
With study specific User Role Setup records and 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 certain object records or update certain fields, Vault automatically sets the Content (blinding__v) 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) field when you create certain object records or when you update the Study, Study Country, or Study Site fields.
Vault uses the value from study specific User Role Setup records or the Create Content field on your user record to set the Content (blinding__v) value.
Creating Blinded & Unblinded Content
Based on your user configuration, Vault automatically sets the Content 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 object records are only available to a small group of users.
Monitoring Event Blinding
When users create a Monitoring Event, Vault defaults the Content field based on the object type. Vault defaults the Content field of related records (for example, Issues and Follow Up Items) to the same Content field value as the related Monitoring Event. Only authorized users can create unblinded Monitoring Events.
Unblinded and blinded visits follow two parallel paths to determine which visit is “previous”. The Previous Monitoring Event for an unblinded visit is the last unblinded visit. Similarly, the Previous Monitoring Event for a blinded visit is the last blinded visit. Vault is able to link the blinded/unblinded visits to their previous Monitoring Events accordingly.
Monitoring Event Seeding Actions
Within Vault CTMS Monitoring Event functionality, seeding actions can be used to copy data into the Monitoring Event, reducing data entry for the CRA.
When Content Field Defaulting is enabled, admins can configure workflows to branch seeding actions based on the Monitoring Event Type to filter content that seeds into the Monitoring Event. When running the Seed Monitoring Participants, Seed Follow Up Items, or Seed Issues action Vault will only seed records of the selected Content value.
Object Blinding Outside of Monitoring Events
If the record is not associated with a Monitoring Event, Vault checks the user’s study specific User Role Setup record and sets the Content field to the most restrictive User Role Setup record value. If the user does not have a User Role Setup record value set, Vault checks the user’s Create Content field. It sets the Content field of the record to the user’s Create Content field. If the user has no Create Content field value, Vault then assesses the object’s Content field default value and defaults the Content field of the new record. If there is no value set at the object level, Vault leaves the Content field on the new record blank.