Improved reporting capabilities

Reports available for a study design

You can now run reports for a study design. Previously, you could run reports only in Testing, Training, and Production modes. The following new reports are available for the study design:

  • Study Design
  • User Access

The reports are described in the following table.

New reports

Some new reports are available in PDF, a new format.

Report Formats Description Available for these roles
Audit Report Sites and Depots

HTML, PDF

PDF is a new report format.

View the audit history for site and depot properties to see the changes that were made and the user who made them.
  • Clinical Supply Manager
  • Site Manager
  • Study Manager
Kit Reconciliation HTML, PDF View the kits that will be or have been destroyed and see whether the kits were reconciled
  • Clinical Supply Manager
  • CRA
  • Lead Site User
  • Site Inventory User
  • View Only - Support
Study Design HTML, PDF

View study design information including a list of visits and forms in the study, kit and randomization information, and subject and supply settings.

You can run this report both in the study design and in each mode.

  • Randomization List Manager
  • Study Design Report (new role)
  • Unblinded Designer
  • View Only - Support
  • View Study Design

User Assignment

User Assignment by Site

CSV, HTML

HTML, PDF

For Testing, Training, and Production modes:

These reports contain the same data organized differently. The reports list users, organized by the site or depot they're associated with, along with their roles, last sign-in date, and other details. You can run the report only for the locations that you are assigned to.

  • User Assignment is most useful to users who want to sort and filter the data in the CSV file, such as sponsor users.
  • User Assignment by Site is most useful for users who don't need to sort and filter data, such as CRAs and site users.

    For the study design, only the User Assignment report is available:

    View each user who has access to the study design, along with the users' roles, access dates, and other details.

    For all the reports, you must choose which data to include:

    If you include historical data, you see every change that has been made to the user. If you include only current data, you see each user's access as of right now.

Both reports are available in Testing, Training, and Production modes for these roles:

  • Lead Site User
  • Site Manager
  • Site User
  • Study Manager
  • User Manager
  • View Only - Support

The User Assignment role is available for the study design for these roles (for each row, users must have both roles to see the report):

  • User Manager and View Design
  • User Manager and Unblinded Designer
  • User Manager and Designer
User Training HTML, PDF View the training that users have completed.
  • CRA
  • Lead Site User
  • Site Manager
  • Study Manager
  • User Manager

Changes to reports

Report Changes
All reports When you generate a report, N/A now appears instead of a blank cell when data cannot be populated.
Subject Events

The report now contains data for the following events:

  • A visit is started
  • A visit is completed
  • A visit is skipped
  • A visit that was skipped is started
  • A visit date is entered or modified
  • A manual screen failure is undone

    All existing columns in the report remain unchanged, and the data in the new columns appears for both new and existing subjects.