Specify data classifications for a study role

Data classifications allow you to control the type of data users can view or edit in a study. Data classifications defined for a study role dictate the type of data a study role provides access to with either view or edit privileges.

In form design, labels for data classifications are assigned to hidden form questions to categorize them as different types of data. Study designers assign these data classification labels when defining a hidden question. Work with your study designer and refer to Define data classifications for a hidden question.

As part of your user management tasks, you define data classifications of a study role to allow either view or edit privileges for each data classification. These study role data classifications can be defined by global user managers or study user administrators, but are only defined at the study level.

How do data classifications work? For instance, study designers can add and hide a question for a subject's Social Security Number in a form and then classify the data as Personal Identifiable Information (PII) data. From the user management side, you assign to the site user and unblinded data manager study roles with the privileges to view or edit PII Data. As a reult, that field gets hidden to all users except for site users and unblinded data managers.

  1. From the Home page, Open the study's settings.
  2. Navigate to the Study Roles tab.
  3. Select the study role for which you want to specify data classifications.
  4. On the right pane, expand Data Classifications.
  5. Select the appropriate check boxes to grant either View or Edit privileges for the available data classifications:
    • Adjudication Data: Data findings generated by an adjudicator from adjudication events or safety and efficacy clinical endpoints.
    • Blinded Data: Data that can reveal information bias in a study.
    • PII Data: Personal Identifiable Information Data.
    • Sponsor Data: Data accessible to a sponsor user.
    • Public Data: Data accessible to sites or other users.
  6. Click Save.

Related Topics

Parent topic: Manage study roles