Make a study version available in Production and Training modes

Move a study version to Approved after the study design is finished and configuration is verified to be compliant with the study protocol. Some study design activities aren't allowed after you move a study version to Approved, even if you create a new Draft version of the study.

These steps are for Production and Training mode. For step-by-step instructions on how to perform this same task for a study that requires your verification, see Make a study live.

WARNING:

To avoid an interruption in the synchronization of data between Oracle Clinical One Platform and Oracle DMW, each time a new study version is moved to the Approved container, the Oracle DMW metadata must be refreshed before any further changes are made to the study design in Oracle Clinical One Platform. If you perform additional changes to your study before the metadata update is complete in Oracle DMW, then the synchronization of production data could be interrupted.

To move a study version from Draft to Approved or Training, you must be assigned the following study roles and permissions:

• The Study Designer study template role (or a custom study design study role) assigned in Study Design mode;
• The Study Manager study template role (or a custom study management study role) that must have the Move a Study Design to Testing or Production permission included in the study role. This study role must be assigned in both Production mode or Training mode.

Want to see how to perform this task? Watch the video below.

1. On the Home page, click the Edit icon () on the study you want make available in Production and Training modes.
2. Drag the Testing version of the study to Approved.
3. Fill in the following fields:

   Field	Description
   For the first study version that you approve in the study	Enter a title for the study version, and click Approve. The study version moves, and its version number does not change.
   For the second or higher study version that you approve in the study	Specify the reason for approving a new study version, enter a title for the study version, and click Approve. For a protocol amendment, the first number increases by 1, and the second number resets to 0. For example, 1.2.0.6 changes to 2.0.0.6. For a revision, such as when you corrected a typo or added a value to a drop-down, the second number increases by 1. For example, 1.2.0.6 changes to 1.3.0.6.

Handling multiple study version updates?

• The study won't be live until you assign a study version to a site and activate each site.
• You can have multiple study versions in Approved.
• You can't move an Approved version of a study back to Testing or Draft. If you need to make changes, see Create a new Draft version of a study to update the Approved version.
• When the study version is no longer in use, you can archive a study version.