Manage Organizations

View and manage standard and custom Organizations.

About Organization Records

Organizations are biopharmaceutical sponsors, partners, agencies, sites (and more) that 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 to which you will submit ICSRs.

Safety comes with a number of standard Organizations by default. You can add custom Organizations as required.

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

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

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

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.
7. In the Address section, add 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.
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 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.
7. In the Address section, add 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.
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

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.
5. Select Save.

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. Note: By default, Vault restricts the FDA Agency to use the FDA ICSR Reporting Rule Set and the EMA Agency to use the EMA ICSR Reporting Rule Set. If you require either of these Agencies to use a custom Safety Rule Set, your Admin can update the Organization object to remove the corresponding restriction from the field-level validation rule on the Agency object type.	Agency
Cross Report Priority	Select one of the following values to determine the priority of generated cross reports in the event that multiple cross reports are generated for the same Destination: Marketing (default) If both a marketing Submission and an investigational Submission would be generated, then Vault will select 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, then Vault will generate the investigational Submission. Investigational If both an investigational Submission and a marketing Submission would be generated, then Vault will select 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, then Vault will generate 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. If the field is left blank, Vault uses default option (Marketing). In the event that an Agency has both X→Investigational and X→ Marketing reporting obligations then Vault prioritizes which Submissions to an agency are generated based on the value of this field as follows:	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

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.

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.
4. 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.
4. Select Continue.

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 to use for the Agency.
   • Localization: Select the Localization record corresponding to the Agency’s region.
   • Cross Report Priority: Select the Cross Report Priority for the Agency.
   • Cross Reporting Substance Lookup Method: Select the Cross Reporting Substance Lookup Method for the Agency.
   • Blinded Product Selection: Select how Vault evaluates blinded Products 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 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.