The Study Build system is where you design and set up your study. Study Runner is part of your the system where your study is carried out (though certain configurations are also set in Study Runner).

Only users with a User Type of Administrator and a User Role of Data Manager can create a study.

To Create a Study:

  1. With a User Type of Administrator and a User Role of Data Manager, log into the OpenClinica Study Manager.
  2. Click the Add a new study link at the top of bottom of the screen.
  3. Enter data into the fields that appear on the Add a new study window.

    If you wish to set a limit on the number of participants that can be added to your study, enter the number in the Expected Number of Participants field and click the checkbox for Disable adding new participants when expected number is reached.
  4. Click Save.

To Set a Limit on the Number of Participants (after study creation):

  1. Click the button and select Settings from any of the following locations:
    • The My Studies screen
    • The Design screen
    • The Share screen
      
  2. In the Settings tab, click Edit.
  3. Check the Disable adding new participants when expected number is reached checkbox.

For example, if you enter 450 in the Expected Number of Participants field, once the number of study Participants reaches 450, site users will no longer be able to add Participants.

Note: The total number of Participants that will be allowed includes Participants with status of Available or Signed. Participants with a status of Removed are not included in the total number. You can view the current number or percentage of Participants in each status in the Participant Status Count table on the home screen of your study.

To Change the Study Settings:

  1. Click the button and select Settings from the drop-down list in any of the following locations:
    • The My Studies screen
    • The Design screen
    • The Share screen
  2. To open the Study Properties screen, click the Edit link to the right of Study Settings.
  3. Change data in the appropriate field(s).
  4. Click the Save button.

Note: You can change settings at any time. The changes take effect immediately, and you do not need to republish the study.

Navigating the My Studies Screen

ButtonNameDescription
SettingsClick this button to go to Settings, User Roles, or Modules. A user can change settings if they have a User Type of Data Manager. Otherwise, users can view the settings.
DesignClick this button to go to Study Designer. This button is only available to users with a User Role of Data Manager.
ShareClick this button to go to the Share screen in the Test or Production environment, depending on which environment(s) the study has been published to and which environment(s) you have access to.
GoClick this button to go to your study in the Test or Production environment, depending on which environment(s) the study has been published to and which environment(s) you have access to.