1 Create a Study

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 as follows:

  • On the My Studies page or the Design page, click the gear icon and select Settings.
  • On the Share page, select the Settings tab.

Then, to the right of Study Settings, click Edit and make the appropriate changes.


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.




Functional approval by Laura Keita (lkeita), Director of Training and Compliance. Signed on 2019-04-08 12:59PM

Approved for publication by Paul Bowen (pbowen), Product Owner. Signed on 2019-04-19 3:12PM

Not valid unless obtained from the OpenClinica document management system on the day of use.