# Manage Organizations You can view and manage standard and custom _Organizations_. Organizations, such as biopharmaceutical sponsors, partners, agencies, and sites, direct transmissions and regulatory submissions to agencies such as the FDA and EMA. _Organization_ records contain data about organizations and security controls. _Inbox Items_, _Cases_, and documents all require linking to an organization. Vault restricts user access to information by role in each organization. Setting up _Organization_ records is a key step in setting up access control. You must set up your Vault with the following _Organizations_: * Your organization (Vault Customer). * Sponsors for which you will process information. * Trading partners with which you will exchange Individual Case Safety Reports (ICSRs). * [Agencies][1] to which you will submit ICSRs. Safety includes a number of [standard _Organizations_][2]. You can add [custom _Organizations_][3] as required. ### Standard Organizations {#standard-organizations} Standard _Organizations_ come preconfigured in each Vault, including _Vault Customer_ and several worldwide health authorities. For a complete list of these standard _Organizations_, navigate to **Business Admin > Objects > Organizations** in your Vault. You can identify standard _Organizations_ by the `__v` in the _API Name_ field. Vault protects standard _Organizations_ from changes that could cause functional issues, which is why you cannot edit the _API Name_ or delete _Organizations_ that contain `__v` in the _API Name_.
### Custom Organizations {#custom-organizations} Configure custom _Organizations_ for any organization involved in case processing or distributions that is not preconfigured in Vault. For example, add the following _Organizations_: * If your organization is a CRO, add each sponsor for which you will process cases and information. * Add each organization to which you will send and receive information, such as cases, reports, and documents. You cannot configure custom _Organizations_ with `__v` in the _API Name_, which identifies a standard _Organization_. ## Set Up Vault Customer {#setup-customer} _Vault Customer_ is a standard _Organization_ record that comes preconfigured in each Vault. To enable FDA gateway _Submissions_, you must configure the _Vault Customer_ for your organization. You can identify the _Vault Customer_ record by the `vault_customer__v` _API Name_. ### Set Up Vault Customer as a Contract Research Organization {#cro} 1. Go to **Business Admin > Objects > Organizations**. 2. Find the _Organization_ record named _Vault Customer_. If there are multiple pages, use the **Next Page arrow** button to move through the list. 3. Hover over **Vault Customer**, and then select the **All Actions** menu. 4. Select **Change Type**, and then in the **Select New Organization Type** drop-down list, select **CRO**. 5. In the **Change Organization Type** window, select **Continue**. 6. On the **CRO: Vault Customer** page, in the **Details** section, update the [_Organization_ fields][4]. 7. In the **Address** section, [add contact information][10]. For organizations that manufacture and report on medical device products, this section is required to populate device fields on the MedWatch 3500A form. 8. (Optional) In the **Localized Organizations** section, for Japan reporting destinations other than PMDA, you can create a _Localized Organization_. 9. In the **Transmission Profiles** section, add the _Organization_'s _Transmission Profiles_ to facilitate ICSR _Transmissions_. 10. (Optional) In the **Distribution Lists** section, create a _Distribution List_ using your _Organization_'s _Reporting Family_ type. This enables generating _Distributions_ for each partner or site with which you must transmit ICSRs. 11. Select **Save**. **Next Steps** [Add secondary _Organizations_][11] for each sponsor for which you will process cases and information. ### Set Up Vault Customer as a Sponsor 1. Go to **Business Admin > Objects > Organizations**. 2. Find the _Organization_ record named _Vault Customer_. If there are multiple pages, use the **Next Page arrow** button to move through the list. 3. Hover over **Vault Customer**, and then select the **All Actions** menu. 4. Select **Change Type**, and then in the **Select New Organization Type** drop-down, select **Sponsor**. 5. Select **Continue**. 6. On the **Sponsor: Vault Customer** page, in the **Details** section update the [_Organization_ fields][4]. 7. In the **Address** section, [add contact information][10]. For organizations that manufacture and report on medical device products, this section is required to populate device fields on the MedWatch 3500A form. 8. In the **Studies** section, add _Studies_ that your _Organization_ monitors and reports on. 9. In the **Products** section, add _Products_ that your _Organization_ monitors and reports on. 10. In the **Combination Products** section, add _Combination Products_ that your _Organization_ monitors and reports on. 11. (Optional) In the **Distribution Lists** section, create a Distribution List using your _Organization_'s _Reporting Family_ type. This enables generating _Distributions_ for each partner or site with which you must transmit ICSRs. 12. In the **Transmission Profiles** section, add the _Organization_'s _Transmission Profiles_ to facilitate ICSR _Transmissions_. 13. (Optional) In the **Localized Organizations** section, for Japan reporting destinations other than PMDA, you can create a Localized Organization. 14. Select **Save**. ## Add an Organization {#add-an-organization} Set up _Organization_ records for any sponsors for which you process cases and any organizations to which you send and receive information. 1. Go to **Business Admin > Objects > Organizations**. 2. Select **Create**. 3. On the **Create Organization** window, select the _Organization_ type, and then select **Continue**. 4. Complete the applicable [fields][4]. 5. Select **Save**. ### Organization Fields {#organization-fields} The following fields may appear:
Field Description Organization Types
Name Enter the name of the organization. All
Organization UID Code Enter the Unique Identification (UID) Code of the organization. Vault uses this value to assign Case UID numbers. Registration Holder, Sponsor
PV Agreement

Select the type of Pharmacovigilance Agreement. Select Agent if your organization acts on behalf of sponsor organizations, as agreed to in the pharmacovigilance contract.

This field impacts how Vault imports the Receipt Date and New Info Date from inbound E2B Transmissions.

 CRO
Sender Type

Select the type of Sender Organization or Individual.

This field is used in E2B report generation for Sender Type (A.3.1.1/C.3.1).

 Agency, CRO, Partner, Sponsor
Submission Rules

Select the Safety Rule Set associated with the Agency.

For more information about Safety Rule Sets, see Standard Reporting Rule Sets and Create Custom Safety Rule Sets.

 Agency
Cross Report Priority

Select Marketing, Investigational, or Marketing and Investigational to determine the priority of generated cross reports when Vault is generating multiple cross reports for the same Destination. If this field is blank, Vault applies Marketing as the priority.

When an Agency has both X→Investigational and X→ Marketing reporting obligations, Vault prioritizes which Submissions to an agency are generated based on the value of this field as follows:

Marketing (default)

If both a marketing and investigational Submission would be generated, Vault selects the marketing Submission. If there are multiple marketing Submissions, Vault generates the marketing Submission with the earliest Due Date.

If there are no marketing Submissions but there is an investigational Submission, Vault generates the investigational Submission.
Investigational

If both an investigational and marketing Submission would be generated, Vault selects the investigational Submission. If there are multiple investigational Submissions, Vault generates the investigational Submission with the earliest Due Date.

If there are no investigational Submissions but there is a marketing Submission, Vault generates the marketing Submission.
Marketing and Investigational Vault generates the Submission with the earliest Due Date. If there are multiple Submissions with the earliest Due Date, Vault selects the Submission with the earliest created registration.
Agency
Cross Reporting Substance Lookup Method

Specifies the Substance lookup match criteria when considering cross reporting obligations to this Agency based on the Substances contained in the Case Product.

Select one of the following options to specify when Vault reports to the Agency based on Case Product Substance:

Cross Reporting Substance Lookup Method Conditions for Reporting to the Agency
Subset Matching (default)

The cross-reportable Product includes all of the Substances within the Case Product. The cross-reportable Product may include additional Substances in this scenario.

Subset Matching includes Exact Matching scenarios.

Exact Matching The cross-reportable Product includes the exact same Substance list as the Case Product.
Partial Matching

The cross-reportable Product includes at least one of the same Substances as the Case Product.

Partial Matching includes both Subset Matching and Exact Matching scenarios.

If the field is left blank, Vault uses the default option (Subset Matching).

See Cross Reporting for more information.

 Agency
Base Clinical Trial Expectedness On

For Clinical Trial Study Cases, specify which date Vault will use to evaluate adverse event expectedness: New Info Dates on Cases or Onset dates on Case Adverse Events. If this field is blank, Vault evaluates expectedness based on adverse event onset dates.

When the evaluation basis is Onset date:

  • Vault expectedness calculations consider the active date range of the MedDRA Term on Study Core Datasheets and Study Product Datasheets.
  • Expectedness is not recalculated when an Inbox Item is merged to an in-flight Case or promoted to a Follow-up Case.

When the evaluation basis is New Info Date:

  • Vault expectedness calculations do not consider the active date range of the MedDRA Term on Datasheets.
  • Expectedness is recalculated whenever new information is added to the Case through merging to an in-flight Case or promoting to a Follow-up Case.

To use this field, your Admin must enable Agency-Based Auto-Expectedness for Clinical Trial Study Cases.

 Agency
Inv.-Marketed Product Expectedness Select a Datasheet type to base expectedness evaluations on when determining the reportability of marketed products within the country of the agency used in clinical trial Studies. If left blank, Vault uses the associated study core Datasheet for expectedness evaluations. Agency
Localization

Select the Localization corresponding to the organization's region.

The Localization option, along with the reporting rules configured for the Organization, control the translations generated for Cases reportable to this Organization.

 All
Manufacturer Site Number Enter the manufacturer's site number. All
EUDAMED Number Enter your EUDAMED number. This field is used for generating EU MIR reports. Agency
Single Registration Number (SRN) Enter the Single Registration Number (SRN). This field is used for generating EU MIR reports. All except Agency and Ethics Committee
Blinded Product Selection

Select how Vault evaluates Case Assessments with blinded Products for the Agency:

  • Blank (Default) or Unblinded Only: Evaluate Case Assessments with open label Products and unblinded Products only. This option does not evaluate Case Assessments with blinded Products.
  • Blinded Only: Evaluate Case Assessments with open-label Products and blinded Products only. This option does not evaluate Case Assessments with unblinded Products.
  • Unblinded (if available): Evaluate Case Assessments with open-label Products, blinded Products, and unblinded Products. If a blinded Case Assessment and an unblinded Case Assessment exist for the same Product-Event combination, evaluate the unblinded Case Assessment. Otherwise, evaluate the blinded Case Assessment.

For more information on Case blinding and unblinding, see Manage Case Blinding.

Agency
## Add an Organization Address {#add-organization-address} Once you add an _Organization_, complete the **Address** section to specify contact information. For organizations that manufacture and report on medical device products, this section is required to populate device fields on the MedWatch 3500A form. ## Add a Manufacturer Site {#manufacturer-site} On _Organizations_, you can add _Manufacturer Sites_ to assist in tracking how many issues occur at specific sites each year. You can link _Manufacturer Sites_ to _Product Registrations_ for the FDA. For _Cases_ involving devices, Case Processors can select a _Manufacturer Site_ for applicable _Case Products_. To add a _Manufacturer Site_, select **Create** and complete the following fields: * _Site Name_ * _Site Number_ ### Site Report Number {#site-number} When you add a _Manufacturer Site_, Vault generates a _Site Report Number_ section. Each time a user generates a _Transmission_ to the FDA for a _Case Product_ with a _Product Registration_ linked to a _Manufacturer Site_, Vault generates a _Site Report Number_ record and adds a link to it in the _FDA Manufacturer Report Number_ field of the _Case Product_. Vault maps this information when generating FDA eMDR and FDA MedWatch 3500A report formats. Vault names _Site Report Number_ records using the format `{SiteNumber}-{CurrentYear}-{Count}`. For example, if the _Site Number_ on the _Manufacturer Site_ is 00003, the current year is 2026, and there are 11 _Site Report Number_ records for the _Manufacturer Site_, Vault names the next record `00003-2026-00012`. When the year changes, the count restarts to `00001`. If a _Transmission_ for a _Case Product_ becomes _Inactive_ or _Withdrawn_, Vault updates the _Site Report Number Status_ of a _Site Report Number_ to _Not Submitted_. The next time Vault generates a _Site Report Number_, Vault reuses the number from the _Not Submitted_ record. ## Edit an Organization 1. Go to **Business Admin > Objects > Organizations**. 2. Hover over the _Organization_, and then select the **All Actions** menu. 3. Select **Edit**, then make the required changes to the _Organization_. 5. Select **Save**. ## Delete an Organization
1. Go to **Business Admin > Objects > Organizations**. 2. Hover over the _Organization_, and then select the **All Actions** menu. 3. Select **Delete**. A dialog box appears asking you to confirm the delete action. 5. Select **Continue**. ## Manage Agencies {#manage-agencies} Safety comes with a number of regulatory authority agencies out-of-box. You can edit these _Agencies_ or add custom _Agencies_. ### Add a Custom Agency 1. Go to **Business Admin > Objects > Organizations**. 2. Select **Create**. 3. In the **Select Organization Type** drop-down, select **Agency**, and then select **Continue**. 4. Complete the following fields on the **Create Agency** page: * **Name**: Enter the _Agency_ name. * **Sender Type**: Select **Regulatory Authority**. * **Submission Rules**: Select the [_Submission Rules_][9] to use for the _Agency_. * **Localization**: Select the [_Localization_][5] record corresponding to the _Agency_'s region. * **Cross Report Priority**: Select the [_Cross Report Priority_][6] for the _Agency_. * **Cross Reporting Substance Lookup Method**: Select the [_Cross Reporting Substance Lookup Method_][7] for the _Agency_. * **Blinded Product Selection**: Select how Vault [evaluates blinded _Products_][8] for the _Agency_. 5. Select **Save**. ### Update Agency Country Jurisdiction To add an _Agency_ to the countries over which it has jurisdiction: 1. Go to **Business Admin > Objects > Countries**. 2. Select the country to which you want to add the _Agency_. 3. Select **Edit**. 4. In the **Agency** field, select the _Agency_. 5. Select **Save**. **Result** If you selected [_Submission Rules_][9] for the _Agency_, _Cases_ with _Products_ or _Studies_ registered to this country will follow the selected _Safety Rule Set_ and auto-generate _Transmissions_ as appropriate. **Next Steps** To enable reporting to this agency, configure a _Transmission Profile_ for the _Agency_. You can configure a _Manual_ _Transmission Profile_ or _AS2 Gateway_ _Transmission Profile_. [1]: #manage-agencies [2]: #standard-organizations [3]: #custom-organizations [4]: #organization-fields [5]: #localization [6]: #cross-report-priority [7]: #cross-reporting-substance-lookup-method [8]: #blinded-product-selection [9]: #submission-rules [10]: #add-organization-address [11]: #add-an-organization