Unblinding Rules

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

Prerequisites

Dependencies

To use this feature, you must first enable the Mask Blinded Data feature in your vault. See How to Enable Mask Blinded Data.

Required Permissions

Users with the CDMS Lead Data Manager or CDMS Super User standard study roles can perform the actions described below by default. If your organization uses custom study roles, your role must grant the following permissions:

Type Permission Label Controls
Functional Permission Workbench Tab

Ability to access and use the Data Workbench application, via the Workbench tab
Functional Permission Manage Sources

Abiltiy to view and manage Sources from the import of third party data in CDB
Functional Permission Manage Unblinding Rules

Abiltiy to create and manage Unblinding Rules for the conditional unblinding of data in CDB

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

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, hover over your Source to show the Source Actions menu. From the Source Actions menu, select 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:

Column Description
Form The Name of the Form. Clicking the linked form name opens the Unblinding Rule for the Form.
Configured Rules CDB shows a green checkmark in this column if the Form has an unblinding rule configured.
Status If the rule has errors, a warning icon displays in this column.
Rule Created Date The date and time the Unblinding Rule was created.
Last Modified Date The date and time the Unblinding Rule was last modified.
Last Modified By The User Name of the user who last modified the Unblinding Rule.
Last Date Applied The date and time the Unblinding Rule was last applied.

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 itemm’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.

Rule Evaluation: Rules evaluate during the import of data, not upon rule creation.

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.

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
  • Integer, Float
    • Equals
    • Is not equal to
    • Less than
    • Less than or equal to
    • Greater than
    • Greater than or equal to
  • 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