# Configuring Blinded & Unblinded Monitoring Event Data

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 certain object records or update _Study_, _Study Country_, or _Study Site_ field values, Vault automatically sets the _Content_ (`blinding__v`) field value according to the type of content they can create, allowing organizations to securely and confidently manage restricted content in Vault.

Content Field Defaulting in CTMS supports Unblinded Monitoring activities where unblinded monitors are required to complete site visits and review data that is restricted from blinded study team members.

When _Enable CTMS Content Field Defaulting_ setting is enabled and additional Vault configuration is present, Vault determines the default value for the Content (`blinding__v`) field by first checking the Blinding value defined at the study-specific User Role Setup (URS) record level. If no study-specific URS record exists, Vault sets the _Content_ 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_ field based on the default value specified at the _Content_ field level. If none of these exist, the Content field is left blank.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Depending on your Vault’s configuration, the <em>Content</em> field may be labeled <em>Blinding</em>.</p>
    </div>
  </div>
</div>



## Setup Overview

<div class="note-border alert-important">
  <div class="alert alert-important" role="alert">
    <div><i class="far fa-exclamation-circle"></i></div>
    <div class="alert-text">
      <p><strong>Important</strong>: This section outlines the steps required to enable Vault to automatically populate the <em>Content</em> field. It is extremely important that you contact Veeva Services before attempting to perform these steps on your own. Depending on the configuration of your Vault, extensive security updates may be required for this feature to work properly.</p>
    </div>
  </div>
</div>



To enable Vault to automatically populate the _Content_ field, you'll need to complete a series of steps:

- Enable the _Enable CTMS Content Field Defaulting_ checkbox in Vault Settings
- Activate the Content (`blinding__v`) field on CTMS objects
- Set up Blinded and Unblinded Monitoring Events
- Configure the Seed Monitoring Participants, Seed Follow Up Items, Seed Issues system actions to filter on Content
- Update Permission Sets, Study Team Roles, and Role Dependencies to grant access to the appropriate objects, object types, and Content data


## Enabling Content Blinding Field Defaulting

To allow Vault to automatically populate the _Content_ (`blinding__v`) field for a given user, navigate to **Admin > Settings > Application Settings** and select the **Enable CTMS Content Field Defaulting** checkbox.

Enabling this feature does not activate the Content (`blinding__v`) field on CTMS objects. Additional configuration is required to activate fields.


## Activating the Content Field

The standard Content (`blinding__v`) field exists on the following CTMS objects. Depending on your Vault configuration, you may need to activate the field and apply to various Object Types.

* Clinical User Task (`clinical_user_task__clin`)
* Issue (`pdv__ctms`)
* Monitoring Event (`monitoring_event__ctms`)
* Monitored Informed Consent Form (`monitored_informed_consent_form__ctms`)
* Monitored Metrics (`monitored_metrics__ctms`)
* Monitored Subject (`monitored_subject__ctms`)
* Monitored Subject Visit (`monitored_subject_visit__v`)
* Monitoring Visit Participant (`monitoring_visit_participant__ctms`)
* Review Comment (`review_comment__v`)
* Site SAE Tracking (`site_sae_tracking__ctms`)
* Trip Report Answer (`trip_report_answer__ctms`)
* Trip Report Question Response (`trip_report_question_response__ctms`)

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If your Vault has a custom <em>Blinding</em> or <em>Content</em> field, then additional evaluation is required before configuring this feature in your Clinical Operations Vault. Contact Veeva Services to determine the extent of configuration required to activate this feature.</p>
    </div>
  </div>
</div>



## Unblinded Monitoring Events

Configuration is required to enable tracking of Unblinded Monitoring Events within CTMS. Each Monitoring Event type must track either Blinded or Unblinded Content.

### Monitoring Event Object Configuration

To enable standard Content field tracking on Monitoring Events, you'll need to complete a series of steps:

- Add a Default Value of Blinded or Unblinded to each Monitoring Event Object Type
- Apply either the Previous Unblinded Monitoring Event or Previous Blinded Monitoring Event fields to Monitoring Event object types
- Set up Unblinding Monitoring Event Object Type page layouts and security

### Monitoring Event Seeding

When the **Enable CTMS Content Field Defaulting checkbox is enabled,** you can configure Vault to filter records of specific Content when seeding into your monitoring event.

To enable this:

1. Ensure Enable CTMS Content Field Defaulting checkbox is enabled and Content field is active on respective objects.
2. Navigate to the Seed Monitoring Visit Participants, Seed Follow Up Items, or Seed Issues system action in a workflow on the _Monitoring Event_ lifecycle.
3. Add a workflow decision step to determine whether the workflow should Seed Blinded and/or Unblinded records based on the Monitoring Event object type.
4. Update the Seed action to populate the Blinding / Content field based on your seeding preferences.


## User Setup Options

There are several user configuration options you can use to define how Vault populates the _Content_ (`blinding__v`) 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.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If you are adopting Content Defaulting for the first time or transitioning from a custom configuration, Contact Veeva Services to determine the extent of configuration and security updates required to activate this feature. Depending on your Vault configuration, you may need extensive security updates to Dynamic Access Control and Study Team Role assignment for this to function properly.</p>
    </div>
  </div>
</div>



### Via 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`) field value when the user creates or updates records 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.

When users create or update a record, Vault first checks the _Blinding_ value defined on study-specific User Role Setup records. If no study-specific _User Role Setup_ 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.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: CTMS default contenting is only supported for custom objects when the Monitoring Event is referenced as a related document field, rather than a parent field.</p>
    </div>
  </div>
</div>



### 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`) 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.

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_ field for that study.