# Creating Blinded & Unblinded Monitoring Event Data

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.

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      <p><strong>Note</strong>: Depending on your Vault’s configuration, the <em>Content</em> document field may appear as <em>Blinding</em>.</p>
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## About Content Field Defaulting

When [configured](/en/lr/49810/#content-field-config-ref), Vault automatically populates the _Content_ (`blinding__v`) field when you create certain object records.

For Vaults with just 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 Vault 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_](/en/lr/31824/#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 or a study specific _User Role Setup_ record with _Unblinded_ permissions.

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      <p><strong>Note</strong>: Vault does not update the defaulted <em>Content</em> field value when you reclassify the document. Vault also does not override the defaulted <em>Content</em> field when you create the document via API or with a Vault Connection if the source document has a <em>Content</em> field value.</p>
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## 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 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.