What should I do if I have a study that requires users to screen subjects and enter data before and after randomization, but not randomize them?

This design solution gives you more control over when the Randomize button is available.

If you have a study that requires users to screen subjects and enter and edit form data before and after randomization, but do not want them to be able to randomize subjects, review the following details as a possible solution. Contact your Oracle consultant for additional information if this does not meet your needs.

The Edit Form Data for Subjects permission enables the Screen and Randomize buttons in the user interface.

Note:

For more information about this permission, see Descriptions of permissions in Clinical One in the Add Users Guide.

The Randomize button is enabled when the Randomization visit is complete, and the visit is only complete when all required questions have been answered.

The following design gives you more control over when the Randomize button is available.

1. Start by adding a required question to a form in the Randomization visit. For example, Are you ready to randomize the subject?
2. Then, use data classifications to:
   1. Grant view-only access to the new question for users who must screen subjects and enter data before and after randomization.
   2. Grant edit access to the new question for users who need to randomize subjects. The Randomize button is enabled only when all required questions in the visit, including the new question, are answered.

      WARNING:

      Users with edit access to the new required question should randomize the subject soon after answering it. This reduces the possibility of another user randomizing a subject when they should not.