Managing Studies, Study Countries & Study Sites (Clinical Operations)

Configuration of studies, study countries, and sites is important in Clinical Operations Vaults. Study, Study Country, and Study Site are standard objects in hierarchical relationships. Having this metadata as objects, rather than picklist document fields, means that once you’ve created an object record, users can apply all of the record’s metadata to a document simply by selecting the object record. For example, when a user selects a study, Vault applies all study details (Product, Indication, Study Phase, Control, etc.) automatically to the document.

In the object hierarchy, Study is the top level, Study Country is the second highest level, and Study Site is the lowest level object. For example, Study Site 7490 belongs to Study Country United States, which belongs to Study VVT485-301.

Accessing Study Records

You can work with study records from Admin > Business Admin. Some Vaults also include custom object tabs that allow access to Study, Study Country, and Study Site object records from outside the Admin area. With the correct permissions, you can create, edit, and delete records from a custom tab.

Permission sets and sharing rules can control access for viewing, creating, editing, and deleting object records.

Studies

To view Study records in your Vault, navigate to the Study object from Admin > Business Admin or a custom tab. Click into a specific Study to view study details, its Study Countries, and its Study Sites. From here, you can view, add, edit, and delete study information.

How to Create or Edit Studies

To create or edit a study:

1. Navigate to the Study object, either from Admin > Business Admin or a custom tab.
2. Click Create > Study, or click into an existing Study record and click Edit.
3. Fill in details about the study.
4. Optional: Change the Status. This controls whether users can select the study for new documents. Changing a study’s status automatically changes the related sites’ statuses, but does not affect associated documents. The Status field is read-only when objects are managed by a lifecycle.
5. Click Save.

Options that appear in picklists are configurable from Admin > Business Admin > Picklists and picklists associated with studies show Study next to their names.

By default, you can associate a given document with multiple studies. However, an Admin can also restrict the Study document field to one value by checking the Enable Restrict Study to Single Value box at Admin > Settings > Application Settings > Document Fields. This setting affects all documents in your Vault, and once it is enabled, users can only update a given document’s Study field to reduce the number of studies to one or less.

Study Countries

To view Study Country records in your Vault, navigate to the Study Country object from Admin > Business Admin or a custom tab. When configured, you can also view the Study Countries for a single Study in the Study Countries related object section of the Study object record details page. From here, you can view, add, edit, or delete study countries and study country information.

How to Create or Edit Study Countries

To create or edit a study country:

1. Navigate to the Study object record with which you want to associate the Study Country. Scroll to the Study Countries related object section.
2. Optional: You can choose to instead navigate to the Study Countries object record list page from Admin > Business Admin or a custom tab.
3. Click Create, or click into an existing Study Country record and click Edit.
4. Fill in Study Country fields as necessary.
5. Select a Country object record that corresponds to the Study Country record. If enabled, Vault automatically populates the Study Country Name field based on the Country you select.
6. Click Save.

Enabling System-managed Study Country Names

To enable Vault to automatically set the Study Country Name field on a Study Country record, navigate to Admin > Business Admin > Settings > Application Settings and select the Enable Study Country system-managed Name field checkbox. When this checkbox is selected, users cannot edit the Name (name__v) field on the Study Country record.

If you deselect the Enable Study Country system-managed Name field checkbox, users can edit the Name (name__v) field on new and existing Study Country records. Admins can also modify the default expression so that Vault sets the Study Country Name field based on another value.

Study Sites

To view Study Site records in your Vaults, navigate to the Study Site object from Admin > Business Admin or a custom tab. When configured, you can also view study sites for a single Study in the Study Sites related object section of the Study record’s Details page. To access study sites associated with a specific study, click into a Study or a Study Country and scroll to the related object section for Study Sites. From Admin > Business Admin, a custom tab, or the Study record’s Details page, you can view, add, edit, or delete study sites and study site information.

Vault displays an orange “connected” icon () in the Connected field of Study Sites that use SiteVault and have an active Agreement in place. This icon indicates that you can transfer documents and data to that site’s target Vault via Veeva Site Connect.

How to Create or Edit Sites

To create or edit a site:

1. Navigate to the Study object record you want to associate the Study Site with, either from Admin > Business Admin or a custom tab. Scroll to the Study Sites related object section.
2. Optional: You can choose to instead navigate to the Study Sites object record list page from Admin > Business Admin or a custom tab.
3. Click Create, or click into an existing Study Site record and click Edit.
4. Fill in details about the site. You must select an Organization with a valid USN in order for Vault to transfer data to target Vaults via Veeva Site Connect.
5. Optional: Create a Study Person record in the Study Site Personnel section. If you select the Principal Investigator in the Study Team Role field, Vault automatically adds that person to the Principal Investigator field in the Details section of the Study Site record. Note that this does not occur if the field is already populated or if the site is in an Archived lifecycle state.
6. Click Save.

Options in picklists are configurable from Admin > Business Admin > Picklists. Options for the Location picklist are editable in the Locations object records page and picklists associated with sites show “Site” next to their names.

Study Organizations

The Study Organization object allows users to assign specific roles to an organization at the Study, Study Country, or Study Site level. This helps keep track of various organizations’ performance during a study, and what each organization’s role is throughout the course of a study by creating a relationship between the Organization and Study objects. To view Study Organizations, go to the Study Organizations object from Admin > Business Admin, or from a custom tab.

How to Create or Edit Study Organizations

To create or edit a Study Organization record:

1. Navigate to a Study, Study Site, or Study Country details page.
2. Under the Organizations heading, click Create if you want to create a new Study Organization, or click into an existing Study Organization to edit.
3. Select the Organization from the picklist.
4. Click Save.
5. Optional: Add Study Organization Roles.

Study Organization Role

The Study Organization Role section of the Study Organization object allows users to assign and keep track of an organization’s role throughout a study. For example, Organization A may be responsible for quality assurance, while Organization B is responsible for patient recruitment. You could assign each organization its respective role, creating a record of how each organization relates to the study.

SIV Dates (Study Startup)

If Site Activation Progress is enabled, your Vault uses the Planned SIV Date to group sites into Overdue, Due In the Next X Days, and Planned categories and the Actual SIV Date to group sites into SIV Complete.

Site Feasibility (Study Startup)

If site feasibility is enabled, your Vault includes standard configuration elements that allow you to easily collect key investigator and facility data, and help you to manage the review and qualification process to select study site candidates.

Study Products

The Study Product object allows users to associate one or more products to a study. This helps keep track of all the products used across the course of a study.

How to Create or Edit Study Products

To create Study Product records:

1. Navigate to a Study record.
2. Under Products, click Create to create a new Study Product record, or click into an existing one to edit.
3. Select the Product and Study Role, for example, “Placebo.”
4. Click Save.

Study Product Role

The Study Product Role object tracks the different roles that products fill during the course of a study. For example, a study might employ the Cholecap product as the “Lead Agent”, while the WonderDrug product’s role is “Placebo”. You can create Study Product Role object records from Admin > Business Admin to track any role the products in your study require.

Study Product Defaulting

Vault automatically defaults a document’s Product field to the Study Products of “Lead Agent” Study Product Roles related to all studies in the Study field.

You can modify the defaulted values in the Product field on documents that are not reused across studies. However, you cannot save changes if you attempt to add invalid Products.

Vault does not default the Product field on documents classified to profile-related Document Type Groups.

About Statuses & Archiving Studies

To change the status of a Study, select Active, In Migration, or Archived from the Actions menu of a Study object record.

• Active indicates that a study is still open.
• In Migration indicates that a study is currently being migrated from another system to Vault.
• Archived indicates that a study is completed and there is no further work to be done on it.

Note that sites that are not marked as Inactive inherit the study’s current status. When the study is Active, you can set each site’s status individually to Active or Inactive.

Study Status and Site Status are object fields that apply to studies and sites, respectively. You can modify the statuses from Admin > Business Admin > Picklists.