Manage sites, depots, and labs in one place

Sponsor and CRO users can now manage organizations (sites, depots, labs) and their contacts at a global level.

Tip:

Did you know that you can now create and manage locally sourced kits at a site? This new feature can be particularly useful now that you can manage organizations and contacts at a global level. For more information, see Manage locally sourced kits.

To further improve your study management capabilities, you can now create and manage sites, labs, or depots, and their contacts for all studies at your organization, all in one place.

Note:

Additional information and step-by-step instructions on managing organizations and vendors for multiple studies can be found in the Sponsor and CRO User Guide and the Add Users Guide after the RAE upgrade.

Before you work with this feature

This new feature can impact all users who work with sites, depots, labs, or administrate a study in general. The following users should be assigned the Manage Contacts and Organizations and View Contacts and Organizations global roles to be able to manage organizations and their contacts at a global level:

Global user managers
Site administrators
Study managers
Clinical supply managers

Codelist guidelines when working with this feature

During your environment's upgrade, while the contacts and organizations for your site addresses are populated, the State/Province/County and Prefix fields are verified using the Oracle Clinical One Platform system code lists. If the data in these fields does not match, any contact or organization, State/Province/County and Prefix data is cleared during the upgrade.

Note:

These fields are case sensitive; periods (.), and special accents (`) are ignored.

After the migration, if your study has an integration that uploads the State/Province/County and Prefix fields into Oracle Clinical One Platform, the data is verified against the Oracle Clinical One Platform code lists prior to them being imported into the Oracle Clinical One Platform. If the data in these fields does not match, the data points are cleared in Oracle Clinical One Platform only. This does not cause the full integration to fail.

Sponsor users can be notified when the State/Province/County data is cleared via notification. To receive the notification, the user must be assigned the State Set to Null Notification permission. This informs the user that the State/Province/County field has been cleared during integration. The notification includes the following information to help determine the mismatch, so that it can be resolved in the source system:

Study Name
Site Name
Site ID
Site Mode

For more information, reach out to your Oracle point of contact.

Updates to the existing site and depot workflows

If you're a site manager creating sites or labs, or a clinical supply manager setting up depots, here's what you should know about the workflow you used to follow to set up these organizations:

All sites, depots, and labs are created at the global level only. Their addresses and their associations with specific contacts are maintained only at the global level. You can still add a site, depot, or lab to a specific study and this action can be performed at the study level only after that site, depot, or lab was configured at the global level.
On the Sites & Labs tab, you can now click Create Site to add an existing site created at the global level to a study. On the Add Site dialog, you can then enter or modify information, such as the Site ID, Status, Mode, and permissions you'd like to give the site users. You can also associate existing addresses created at the global level with your site and select different shipment addresses by kit type. The same applies for depots.
On the Sites & Labs tab, when you click View Labs, you can now click Add Lab. On the Add Lab dialog you can then search for a lab created at the global level to add it to your study. You can also further assign a lab to a site at the study level.

Details about contacts

When it comes to managing contacts, here's what's new for you:

On the Global Settings page, a new tab called Contacts is introduced.
On the Contacts tab, you can create new contacts, edit or retire them, and filter through them, as well as transfer study sites.
You can filter contacts by study mode, their status, country, state, specialty, or search for a specific contact's name.
For every contact that you create, you must specify any required information and their addresses. A contact can have multiple types of addresses, such as a primary address, a billing address, a shipping address, or an alternate address.
Once you create a contact on the Organizations tab, you can associate that contact with an institution. For example, you may associate the contact of a Principal Investigator with the selected institution.
You can associate the same contact with multiple institutions at your organization.

Details about organizations

When it comes to managing organizations and contacts, here's what's new for you:

On the Global Settings page, a new tab called Organizations is introduced.
On the Organizations tab, you can create, edit, delete, or retire any organization, as well as filter through the organizations that are associated with the organization you work at.
Your options for creating an organization include creating an institution (such as a hospital) or a vendor (such as a lab or a depot facility).
For every organization that you create, you must specify any required information, as well as their addresses. An organization can have multiple types of addresses, such as a primary address, a billing address, a shipping address, or an alternate address.
For an institution, you can also create departments to better organize the hierarchy and workflows at that specific organization.
Upon creating an institution, you can associate a contact with that institution, and then you assign that institution to a study and a specific study mode at your organization. This effectively creates a site that becomes available in the studies that you associated that site with. For example, if you create Hospital A and associate it with Contact B, and assign it to Study-123 in Production mode, Hospital A will show up on the Sites & Labs tab, in Study-123.

Details about setting up a master address

You can now reduce the amount of places you update a primary address by creating that address once and using it throughout your studies, letting you manage a recurring address in one place, as opposed to updating it in numerous contacts or organizations. Here's what's new when it comes to setting up a primary address:

Smart search identifies new addresses, enabling you to quickly add or update addresses.
Creating or modifying a master address updates the address across all associated contacts and organizations.
The first address entered in the system becomes the default primary address.
The checkbox option allows you to copy the primary address into other address fields, such as Billing or Shipping.
At least one address is required and must be selected as the main primary address.

Already working in a live study?

If you're currently working in a live study that has sites, depots, or labs setup, you must know that Oracle will handle the migration of all of your organizations and vendors at the global level. The transition will be seamless, ensuring that your studies are not compromised throughout their study conduct period.

This new feature is not available in the Release Assessment Environment (RAE), but you can reach out to your Oracle point of contact for more specific information, as well as to request a separate testing environment.