Define study details

All studies created in Oracle Site Select have a study details page where you'll specify the study's unique attributes that will be used across the application.

You must have Study administration or Study details management permission to define the details of a study. To set study status and study type, you must have Study administration permission.

Note:

Some fields below are available only if a composite datasource is attached to the study.

1. Select the study from the Study drop-down list.
2. In the top navigation, hover over setup and click study details.
3. Edit any of the following fields:
   • Study name (required, 100 character maximum)
   • Protocol number (required, 100 character maximum)
   • Protocol title (required)
   • Protocol phase (required)
   • Protocol compound (50 character maximum)
   • Study therapeutic area
   • Study sponsor
   • Study indications
   • Study status (required, Study administrator users only)
   • Study type (required, Study administrator users only)
   • Study internal description
   • Study internal ID
   • Study internal status
   • Study internal owner
   • Study internal partner ID
   • Study integration ID
4. At Study information for site users, see or enable:
   • Include a study information video in Select Lite: By design, this control is not actionable. Contact your Oracle administrator to enable the video option. When enabled, the control displays as toggled on on the Study details page so you can validate the video link.
   • Include a study information download in Select Lite: Toggle on to enable and upload a study-level document in DOC, DOCX, PDF, or ZIP format.

   WARNING:

   Access to the file download is not restricted based on the Oracle Site Select LITE user's current workflow task. Please do not configure documents for download that should be available to a site user only after they have completed a specific task or signed a legal agreement. For instance, do not configure a protocol document for download as it will be available to site users prior to signing a CDA.

5. At Additional site selection options, see or toggle:
   • Site acceptance emails can be sent to sites
   • Site decline emails can be sent to sites
   • Sites can be migrated to site activation in Oracle Activate: By design, this control is not actionable. Contact Oracle Support to enable site data migration into Oracle Site Activate during the Finalize step. When enabled, this control will display as toggled on on the Study details page.
6. At Study close message for site users, optionally enter a brief message to display in Oracle Site Select LITE when a study is no longer accessible to site users (i.e., study is in Closed or Cancelled status). Note that your account administrator must also enable a separate Authentication setting to hide studies in Closed or Cancelled status.
7. Click Save.