Who can create a study

Only users with a User Type of Administrator can create a Study. For information on User Types and User Rolessee User Access.

How to create a study

To create a Study:

  1. With a User Type of Administrator, log into the OpenClinica Study Build System.
  2.  To open the Add a new study window, scroll to the bottom of the screen, and click Add a new study.
  3. Enter data in the fields that appear on the Add a new study window.
  4. Click the Save button.


Note: To view definitions for a field, click the Show field definitions link, and hover your cursor over the field for which you want to see a definition.

To set a limit on the number of Participants that can be in the Study:

  1. Enter a number in the Expected Number of Participants field.
  2. Check the Disable adding new participants when expected number is reached checkbox.

For example, if you enter 100 in the Expected Number of Participants field, once the number of Participants reaches 100, users can no longer add Participants.

Note: The total number of Participants includes Participants with a Status of Available or Signed. Participants with a status of Removed are not included in the total number.


To change the Study Settings:

  1. Click the Gear button in the header throughout the system, and select Settings from the drop-down list.
  2. To open the Study Properties window, 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. When you change data in the Settings window, you do not need to republish the Study, and changes take effect immediately in both Test and Production environments after saving.