Unblinding Rules

You can define rules to conditionally unblind data from third party sources.

Accessing Unblinding Rules

To access unblinding rules, you must navigate to the Import > Sources page for your Study. You can navigate to Import from either the Study menu or the Navigation Drawer, after you open your Study.

From Import > Sources, locate your Source and click Unblinding Rules. This opens the Unblinding Rules page. It lists all Forms in the Source. From here, you can open a Form and configure unblinding rules.

The Unblinding Rules page shows the following columns:

Create an Unblinding Rule

You can create one unblinding rule per form. When the rule evaluates as true, CDB unblinds the selected Items. You can base the rule on multiple Item values.

You can create Groups within the rule. All conditions within a group use AND logic. Groups are evaluated with OR logic. A rule can have up to six (6) Groups.

1. From Unblinding Rules, click the Form to open it.
2. Select an Item.
3. Select an Operator. Available operators depend on the data type.
4. Enter a Value to compare the item’s value to.
5. Repeat steps 2 through 4 for all conditions that you want to include in the Group.
6. To remove a condition, click (Remove).
7. To create a new Group, click Add Group. Then, repeat steps 2 through 4 for each item condition in that group.
8. Drag Items from Items to Unblind to Select Items to Unblind. This marks those Items to be unblinded when the rule’s conditions are met.
9. Optional: Click Select All to select all Items for unblinding.
10. When finished, click Save.

Available Operators by Data Type

The available operators for rules depend on the data type of the Item:

• Text
  • Equals
  • Is not equal to
  • Contains
  • In
  • Not in
• Integer, Float
  • Equals
  • Is not equal to
  • Less than
  • Less than or equal to
  • Greater than
  • Greater than or equal to
  • In
  • Not in
• Date, Datetime
  • Equals
  • Is not equal to
  • Less than
  • Less than or equal to
  • Greater than
  • Greater than or equal to
• Boolean
  • Equals
  • Is not equal to

Edit an Unblinding Rule

To edit an unblinding rule:

1. Navigate to Unblinding Rules.
2. Click the Form to open it.
3. Click Edit.
4. Make your changes.
5. Click Save.

Managing the Unblinding Rules Deployment Workflow

The deployment workflow for unblinding rules allows you to track rule readiness and ensure that only tested and authorized ules reach production. The workflow provides deployment statuses, an Unblinding Rule Approvals Log, and prohibits editing in production environments.

There are three deployment statuses:

• Draft: The initial state for new or modified rules.
• Ready For Approval: Indicates the rule is tested and awaiting review.
• Approved: Indicates the rule is authorized for deployment to production.

By default, all new rules are assigned the Draft status.

Changing the Deployment Status

Users with the Manage Unblinding Rules permission can change deployment statuses.

To change the deployment status:

1. From Unblinding Rules (in your test environment), click the Form to open it.

2. From the Deployment Status dropdown, select a new status: Draft, Ready For Approval, or Approved.

3. Optional: Enter a Reason for the change in the Deployment Status dialog.

4. Click Save. The Reason is saved to the Unblinding Rule Approvals Log.

If you edit and save a rule with a status of Ready For Approval or Approved, CDB automatically reverts the status to Draft. You must re-approve the rule before it can be redeployed. Deploying a rule to production triggers a refresh of the most recent data source.

Inactivate an Unblinding Rule

You cannot delete unblinding rules. To stop a rule from running, you must inactivate it in your test environment and then deploy the changes to production.

To inactivate a rule:

1. From Unblinding Rules (in your test environment), click the Form to open it.

2. Click the down caret and select Inactivate Unblinding Rule.

3. Click Inactivate.

4. Optional: To reverse the previous step, select Activate Unblinding Rule from the down caret.

5. A red pill indicates that the unblinding rule is Inactive.

6. Deploy the inactive rule to production.

Download the Unblinding Rule Approvals Log

CDB maintains an audit trail of all deployment status changes with the Unblinding Rule Approvals Log.

To download the approval log:

1. From Unblinding Rules, click the Form to open it.
2. Click the down caret and select Download Approvals Log.
3. Save the CSV file.
4. Review the CSV file in your preferred application.

Unblinding Rule Approvals Log Columns

The Unblinding Rule Approvals Log CSV file contains the following columns: