# Managing Blinded & Unblinded Objects

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 or classify a document, 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][1] 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][2]. 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][3].

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      <p><strong>Note</strong>: Depending on your Vault’s configuration, the <em>Content</em> document field may be labeled <em>Blinding</em>.</p>
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## 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][4] feature.
  * Add the _Content_ (`blinding__v`) [shared document field][3] to all applicable document types.
  * Optional: Configure the **Change to Blinded** [user action][5] at any applicable document lifecycle states.
  * Set the _Blinding_ value on the study-specific [_User Role Setup_][1] record, the _Create Content_ field on the [_User_ object][2] record, or the [_Content_ document field][3].
  * Optional: Prevent users from selecting the [**Send as Link**](/en/lr/4876/#setting) action for restricted content.

## Enabling Content Blinding Field Defaulting {#enable}

To allow Vault to automatically populate the _Content_ (`blinding__v`) document field, navigate to **Admin > Settings > Application Settings** and select the **Enable Blinding Document Field Defaulting**  and, optionally, the **Enable Enhanced Blinding Defaulting** checkbox.

Note that enabling this feature sets the _Content_ (`blinding__v`) field to **Read Only** and **Not Required**.

When you only select the **Enable Blinding Document Field Defaulting** checkbox, Vault defaults the _Content_ field to _Unblinded_ when the user uploading the document has a _User_ record with the _Unblinded_ value for the _Create Content_ field. 

When you select the **Enable Blinding Document Field Defaulting** and **Enable Enhanced Blinding Defaulting** checkbox, Vault only defaults the _Content_ field on documents to _Unblinded_ when you complete the following configurations:

1. Select any value except for _Open-Label_ for the _Masking_ field on the _Study_ record related to the document. 
2. Add the **Allow** **Unblinded** value to the _Document Type Groups_ field on the _Document Type_. 
3. Ensure the user uploading the document has a _User_ record with the _Unblinded_ value for the _Create Content_ field.

## Adding the Content Field {#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 or classifies documents.

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](/en/lr/68414/) if _Content_ [field defaulting][4] is disabled in your Vault.

## Configuring the Change to Blinded User Action {#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:

  1. Navigate to **Admin > Configuration > Document Lifecycles > [Lifecycle] > States > [State] > User Actions** and click **Edit**.
  2. Click **Create Rule**.
  3. In the drop-down, select **Change Blinding Field Value From Unblinded To Blinded**.
  4. Enter a **Label**. We suggest **Change to Blinded (Unrestricted)**.
  5. Click **Save**.

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      <p><strong>Note</strong>: Users can access this action only if they have both <em>Blinded</em> and <em>Unblinded</em> values set at the <em>User Role Setup</em> record level or the <em>Create Content</em> field level on their <em>User</em> object. Their document roles must also include the <em>Edit Fields</em> permission to complete the action.</p>
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## 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](/en/lr/31824/) to ensure that Vault shares the content with the correct group of users.

### Via User Role Setup & Study Person {#user-role-setup}

You can [configure a _User Role Setup_ record](/en/lr/31824/) 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_](/en/lr/61542/) 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 {#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**](/en/lr/49807/) 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 {#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 {#content-field-config-ref}

This table lists the effects of configuration options for [content field defaulting][3] in the Document Inbox:

|Content Field Defaulting|Content Field Requiredness|[Classify Later](/en/lr/15020/) Behavior|[Drag & Drop](/en/lr/68414/) Behavior|[Vault Mobile/API](/en/lr/71324/) Behavior|
|--- |--- |--- |--- |--- |
|Enabled|Required OR Optional|Vault does not display the _Content_ field, and defaults the value based on [Content Defaulting][3] 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.|

 [1]: #user-role-setup
 [2]: #user-object
 [3]: #content-field
 [4]: #enable
 [5]: #user-action