Create your very own library study

Users at a sponsor organization or Clinical Research Organization (CRO) can now create their own library study and include objects in these libraries to be used in live studies.

By creating your own library study, you can not only reduce the time for study building, but you can also better manage standards for study metadata and improve the consistency of design throughout all studies at your organization. With every object created and tested within the context of a library, users can then add these objects to a live study ensuring that their protocol is up to the organization's standards.

Before you work with this feature

This new feature can impact global users, as well as study designers. As a global user manager, you can assign the following new global roles to users so they can view and manage library studies:

Change Library Objects Status
Manage Library Objects
View Library Objects

Details for library users

Here's what's new for you:

Note:

For this release, you can only include forms as objects in your library.

Now, when you navigate to the Library page, you land on the Library Studies page where you can create and manage all of your library studies.
On the Library Studies page, you can click View Library. This takes you to the organization's library where you can navigate between the Code List tab and the Forms tab. The new Forms tab contains all of the forms from your library studies. The Code List tab has no functional changes and it will still display all of your organization's custom and system default code lists.
On the Library Studies page, you can click Create Library Study, fill in the fields of the Create Library Study dialog and create a new library study in your library.
On the Library Studies page, a library study is displayed similarly to how a study is displayed on a Home page. A library study can be versioned and moved through all four different containers: Draft, Testing, Approved, and Archived.
By clicking a library study in the Draft container, you can navigate to the Forms tab within a library study. You can then choose between creating a brand new form or importing an existing form from another live study or another library study at your organization.
An object in a library can have various statuses. By default, when you import or create a new object, its status is set to Draft. Other statuses that an object can have are Testing, Rejected, Approved, Published, or Archived.
After you create an object in a library study, you can test it, approve it, and then publish that object in your library study. Only after you test, approve, and publish an object within your library study, can you add it to a live study and further test it in that updated study version.
You can choose to version an object that was already published so that your library contains multiple iterations of the same object. For example, you can choose to create two or three different versions of the same Demographics form. All of the different versions can be used across live studies at your organization.
Irrespective of its status, you can always edit an object's attributes, such as its description and associated tags.
Along the top of the Library page, you have several options to make navigation of library objects easier: you can filter objects by status or tag, you can expand or collapse all objects to view or hide their details, or you can search for a specific library object.
On the right side of the Library page, upon selecting an object, you can view its history on the Object History side panel.

Reporting updates

Objects created in library studies will be displayed in reports and datasets in Oracle Clinical One Analytics for a future release.

Impact on integrations

You cannot set up integrations for library studies.

Impact on custom JavaScript rules

As a rule designer and tester, you must know that you can create custom rules in a library study, as well. The workflow for creating, testing, approving, and ultimately publishing a custom rule in a library study is the same as the workflow that you follow for a live study.

When you add an object with custom rules to a live study, keep in mind that all custom rules are imported in the live study with a status of Invalid. You will then have to test, approve, and publish the copied rules to ensure that they run correctly in your updated live study version.

Already working in a live study?

As soon as the release upgrade is complete, you can begin creating library studies and adding objects to them. You can add forms to your new library study from any other study whether it is newly created or already live.

You can find additional information in the Sponsor and CRO User Guide after the Release Assessment Environment (RAE) upgrade.