Create a study

When you're ready to start building a study, you can create the study and add users to it. Don't forget to add yourself, or you won't be able to work. Follow the same steps to create a rollover study.

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

1. On the Home page, click Create Study.
2. Fill in the fields and click Save. To view tips for completing a field, click into the field or choose an option.

   Field or setting	Description
   Study Title	Enter the title of the protocol.
   Study ID	Enter a unique value, such as a protocol acronym and protocol number.
   Study Phase	From the drop-down, select the phase of your study.
   Therapeutic Area	From the drop-down, select the therapeutic area of your protocol.
   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.
   Study GUID	Click Copy GUID if you need to use the study GUID in setting up an integration with Oracle Central Coding, for example.
   Company	Enter the company name to help you identify and associate a study with a company, if you plan to use the filter.

   The new study is added to the Home page. By default, the study contains a study version of 1.0.0.1 with a status of Draft.

3. Give the study team access to the study so that they can start working in it. For instructions, see Create study user accounts.
4. To complete the study setup in the Oracle Cloud, you must activate your study.

   Note:

   If you don't submit a support ticket, errors will occur when you try to perform some tasks.

If you want to open a study or create a new Draft version, see Open a study's design or Create a new Draft version of a study to update the Approved version.