**Source URL:** https://clinical.veevavault.help/en/gr/4345/index.md # Managing Studies & Study Related Objects 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 {#page} 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 {#editstudy} 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 {#enable-study-country-auto-naming} 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 {#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 (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 {#createsite} 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 {#study-org} 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 {#create-edit-study-org} 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. Optional: If configured, select **Yes** or **No** in the _Separate Payment Request_ field. 5. Click **Save**. 6. Optional: **Add** _Study Organization Roles_. For Vaults using the _Separate Payment Request_ field, the field controls if the _Generate Payment Request_ action combines the _Payable Item_ for the _Study Organization_ record with _Payable Items_ for other _Study Organization_ records tied to the same _Organization_. ### 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 {#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 {#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 {#managing-archived-studies}
To change the status of a single _Study_, select **Active**, **In Migration**, or **Archived** from the **Actions** menu of a _Study_ object record. You can only update the migration status of multiple _Study_ records using Vault API. Learn more about how to bulk update studies' migration status in the Veeva Vault Developer Portal. The following statuses are available: * **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. 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**. [1]: #page [2]: #editstudy [3]: #enable-study-country-auto-naming [4]: #study_sites [5]: #createsite [6]: #study-org [7]: #create-edit-study-org [8]: #study-product-role [9]: #product-defaulting [10]: #managing-archived-studies