Create and design a library study

You create a library study to include study design objects that you can test, approve, and then re-use in other studies.

Before you begin, learn more about the specifics and limitations of a library study. For more information, see About library studies.

To create and design a library study version, follow these steps:

1. On the homepage, click Library.
2. In the upper-left corner of the page, click View Library Studies.
3. On the Library Studies page, click Create Library Study.
4. On the Create Library Study dialog, fill-in the fields and click Save.

   Note:

   After clicking Save, an Information message may appear stating that creating this study may take longer. Click OK and follow the progress icon on the Library Studies page to see when your library study is saved. While the study is saved, a message is displayed on the study that states: "Creating Study...".

   Field	Description
   Study Title	Enter the title of your library study. You can use a title that is relevant to your library study based on information related to the study's therapeutic area, indication, or phase. Make sure that the title is unique in the application.
   Study ID	Enter a unique value that is relevant to your library study.
   Study Phase	From the drop-down, select the phase of your study.
   Therapeutic Area	From the drop-down, select the therapeutic area of your library study.
   Open Label/ Blinded	From the drop-down, select the type of study you want to create, whether it is: Open Label Blinded Blinded and Open Label Observational Your selection does not determine whether unblinding information is revealed.
   System Code List	From the drop-down, select the system code list group that you want your study to use. For more information, see Assign a system code list group to your study.
   Company	Select the company name to help you identify and associate a library study with a company, if you plan to use the filter.

   The new study is added to the Library Studies page. By default, the library study contains a study version of 1.0.0.1 with a status of Draft.
5. A library study must contain several other design elements, as well as study configurations. These are required for you to properly test the objects that you create in a library study. For step-by-step instructions on how to design and configure a library study, see the following:

   Task	Notes
   1. Create a study role for one study.	As an alternative, you can also use the Oracle predefined study roles already present in your library study. A user administrator must perform this task.
   2. Add a user to a study.	A user administrator must perform this task. Note: At a minimum, you should add a study designer who can create library objects in your library study's design.
   3. Create a custom code list	A study designer must perform this task.
   4. Create visits and define the visit schedule.	A study designer must perform this task.
   5. Create objects or import objects.	A study designer with the global roles Change Library Objects and Manage Library Objects must perform this task.
   5. Create and manage custom rules.	A rules designer must perform this task.
   8. Add a site to a study.	A site administrator must perform this task.
   9.Specify study, enrollment, and visits settings.	A study manager must perform this task.
   10. Specify settings for a source data verification strategy.	This step is optional. If you choose to specify settings for a source data verification strategy, you'll have to create the actual strategy, too. For step-by-step instructions, see Create a source data verification strategy and assign it to a site. A study manager must perform this task.

After going through all of these steps, your study will be ready for use. You can start creating or importing objects, as well as testing, approving, and publishing them in your library.