Create a new Draft version of a study to update the Approved version

Create a new Draft version of a study when you need to update a study version that has already been moved to Approved on the Home page. You can modify details about the study, including its title, phase, and blinding status at any time, without creating a new version of a study. This procedure also applies to rollover studies.

Before you create a new draft study version to move to Approved, consider the following:

• You can change the name of the study version, but not the version number.
• Oracle Clinical One Platform allows you to make changes only when they won't create issues for data that might have been collected.
• Consider the implications for subjects who are already in the study before changing visits, particularly if the edits change the visit schedule. For example, don't delete the Screenig visit because all future visits are scheduled from it or use caution when changing the visit window because you could affect the ability of active subjects to get a dispensation.
• If you need to change a visit, we recommend editing an existing visit rather than adding a new one.

Note:

To move a study version from Draft to Approved, 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 Production mode.

Need to perform this task for a study you need to verify? See Create a new Draft version of a study to update the Testing version.

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 to edit.
2. In Draft, click Create Study Version.

   Tip:

   If you already have a Draft version of the study, Create Study Version doesn't appear below Draft. To create a new version of the study, you must first drag the Draft version of the study to either Testing or Archived.

   The new Draft version is a copy of the latest version of the study. The latest version of the study has the highest fourth number (for instance, 4 in 1.0.0.4). When you create a new Draft version of a study, this number increases by 1. For example, 1.0.0.1 becomes 1.0.0.2.

3. To rename a study version, click the Edit icon on the study (). Click the Menu icon () on the study version and select Rename.

Note:

For custom JavaScript rules, you must know that only rules in the Approved state will be published once you update a study's version. These rules will run on all subject data, including existing and new data.