1. Release Notes
  2. What's new
  3. Study site management

Study site management

Permissioned users can now track assignments, scheduling, and status for pre-study visits; site profile enhancements introduce new and relabeled fields, and more

Pre-Study Visit dashboard

In release 23.2, Oracle Site Select introduces Pre-study visit tracking. A new “PSV dashboard” permission grants users view and edit access for a new PSV tracker via a new Dashboards menu item. An Oracle Site Select user who manages user roles and permissions can add the PSV dashboard permission to a new or existing role definition and add the permission when defining a team or business collaboration team.

The Pre-study visit tracking page includes a study picker that lists only those studies the logged-in user has permission to access. Sites included in the grid have progressed to at least the Recommended bucket state, and by design, the grid displays sites even when they have moved out of Recommended. The Current Status column indicates the site’s current bucket state.

Editable columns in the grid allow PSV dashboard users to update values for:

  • Assigned user – Lists users in the account who have PSV dashboard permission
  • PSV scheduled – Date and time input
  • PSV status – Pending, Scheduled, or Completed
Pre-study visit tracker with site grid

PSV dashboard users can also export the dashboard to Microsoft Excel. The export, with the default file name format “Select - PSVtracking - <ddMONyyyy>.xlsx.,” will be formatted as follows:

  • The study name is the title of each Excel worksheet
  • Each worksheet includes the sites from each study selected in the study picker
  • The PSV tracker columns are the columns in each worksheet
  • The site rows in the PSV tracker export to each worksheet with the data displayed in the grid
Example Microsoft Excel export

When the PSV dashboard user clicks Done, they will navigate to the homepage for the last study they visited. If no study is in session, the user’s myDashboard page displays instead.

EPIC: SEL-11118

Site profile

Patient demographics

With release 23.2, we made three enhancements to the Site profile's Patient Demographics tab:

  1. New input validation ensures totals for the Gender, Age, Race, and Ethnicity sections equal 100%. Validation also includes text and green, orange, and red font color feedback in the user interface (e.g., total in green when 100). Additionally, the page's "Done" button will be enabled only when all section totals are 100%.
  2. The Gender section now includes Other and Unknown gender fields. We also added these fields to the Oracle Site Select Standard site profile columns. Like Male and Female gender fields, these new Other and Unknown fields can be imported via datasource imported and mapped, displayed in and exported from the site grid, viewed in the site scorecard, etc.
  3. In the Race section, we relabeled "Native American" to "Indigenous / Native American." We also updated the description to: "A person belonging to a group that is native to a particular place with strong ties to surrounding natural resources and historical continuity with pre-colonial and/or pre-settler societies (e.g., Native Americans, First Peoples, Aboriginal people, etc)." Additionally, in the Site scorecard, the label "Native American" is now "Indigenous."
Patient demographics tab with input validation feedback, new gender fields, and relabeled Indigenous / Native American input in the Race section.

Activation contacts

The Site profile's Site Contacts subtab now includes a new "Activation contacts" section to optionally record contact details for the site's Budget, Legal, and Regulatory coordinators. By design, users can enter partial data for each contact (e.g., only last name); all fields are optional. Oracle Site Select will forward Activation contact data for use in the site activation phase.

An Activation contact's data can be imported via a datasource import and will save to the Site profile when the site profile record is saved for a site. Additionally, an update to an Activation contact's saved data will update that contact's record in the Site profile datasource.

Oracle Site Select site grid users can add Budget, Legal, and Regulatory coordinator contact detail columns to the grid and export the data if preferred. However, Oracle Site Select will not send study-related emails to Activation contacts, and users may not add Activation contacts to Study contacts in the Site profile. This is expected behavior and is by design.

Site contacts subtab displays the new Activation Contacts section

EPIC: SEL-15402

Site history

With release 23.2, we added the "master profile ID" to the Site history page. The ID displays just below the study site's institution name and can be helpful if troubleshooting site matching issues. This ID is an internal ID used mainly by Oracle Support and Services.

EPIC: SEL-15402

Parent topic: What's new