Who can create a study

Only users with a user type of Administrator and a user role of Data Manager can create a study. For information on user types and user roles, see User Access.

How to create a study

As an administrator, log into the OpenClinica study build system and click Add a new study.

The Add a new study window displays.

For definitions of the field, click Show Field Definitions, then hover over each of the fields to display the definition.

Note that you have the option to “Disable adding new participants when expected number is reached.” If your expected number of participants is 100, when the study reaches 100 participants, the “Add New Participant” functionality is disabled and no more participants can be added. This total count is based on all participants with a status of “Available” and “Signed” – it does not track “removed” participants as part of that total count.

You can reset the study settings at any time by going to My Studies > Share, choosing Test or Production, and then accessing the Settings tab:


When you update settings, there is no need to republish the study – changes take effect immediately.

Enter values for each of the fields and click Save.