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.
Note: Depending on your Vault’s configuration, the Content field may be labeled Blinding.
Setup Overview
Important: This section outlines the steps required to enable Vault to automatically populate the Content 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.
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)
Note: If your Vault has a custom Blinding or Content 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.
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:
- Ensure Enable CTMS Content Field Defaulting checkbox is enabled and Content field is active on respective objects.
- Navigate to the Seed Monitoring Visit Participants, Seed Follow Up Items, or Seed Issues system action in a workflow on the Monitoring Event lifecycle.
- Add a workflow decision step to determine whether the workflow should Seed Blinded and/or Unblinded records based on the Monitoring Event object type.
- 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 to ensure that Vault shares the content with the correct group of users.
Note: 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.
Via User Role Setup
You can configure a User Role Setup record 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 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.
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.