First Steps for SafetyDocs Administrators

Learn how to set up your environment to get started with Vault SafetyDocs.

Sections in this article

Set Up Organizations

As all records require linking to an organization for security, the first task you should complete as an Administrator is to set up Organization records.

Set up your organization using the Vault Customer record. You can identify the Vault Customer record by the vault_customer__v API name. If your organization is a CRO, you must also create secondary Organization records for each sponsor.

  • Add a Contract Research Organization as Vault Customer
    1. Go to Business Admin > 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 edit-cell-button
    4. Select Change Type, and then in the Select New Organization Type dropdown 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. Note that fields appear based on your vault's configuration.
    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 Submissions and Distributions.
    10. (Optional) In the Distribution Lists section, create a Distribution List using your Organization’s Reporting Family type. This enables automatically generating Distributions for each partner or site with which you must transmit ICSRs.
    11. Select Save.

    Next Steps

    Add secondary Organization records for each sponsor for which you will process cases and information.

  • Add a Sponsor as Vault Customer
    1. Go to Business Admin > 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 edit-cell-button .
    4. Select Change Type, and then in the Select New Organization Type dropdown list, 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 automatically 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 Submissions and Distributions.
    13. (Optional) In the Localized Organizations section, for Japan reporting destinations other than PMDA, you can create a Localized Organization.
    14. Select Save.
  • Add Secondary Sponsor Organizations
    1. Go to Business Admin > Organizations.
    2. Select Create.
      The Create Organization window appears.
    3. On the Create Organization window, select the organization type, and then select Continue.
    4. Complete the fields that appear.
      The following table describes the Organization object fields that may appear, depending on your vault's configuration:
      Field Description
      Name
      (name__v)
      Enter the name of the Organization.
      Organization UID Code
      (organization_uid_code__v)
      Enter the Unique Identification (UID) Code of the Organization. The system uses this value to assign Case UID numbers.
      By default, this field appears only for Sponsor-type Organizations.
      PV Agreement
      (pv_agreement__v)

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

      By default, this field appears only for CRO-type Organizations.

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

      Sender Type
      (sender_type__v)

      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).

      Submission Rules
      (submission_rules__v)
      Select the submission ruleset associated with the Organization.

      Note Submission Rules are intended for use with Agency-type organizations only, and populating this field assigns a reporting ruleset to the Agency. For more information, see Regulatory Agency Reporting Rules.

      Cross Report Priority
      (cross_report_priority__v)

      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
      • Investigational
      • Marketing and Investigational

      The system will assume the default option (Marketing) if the Cross Report Priority field is left blank.

      Note Please contact Veeva Managed Services if you need to enable this functionality in your vault prior to the 22R3 release (December 2022).

      In the event that an Agency has both X→Investigational and X→ Marketing reporting obligations then the system prioritizes which Submissions to an agency are generated based on the value of this field as follows:

      Marketing (default value)

      If both a Marketing Submission and an Investigational Submission would be generated, then the system will select the Marketing Submission.

      If there are multiple Marketing Submissions, the system generates the Marketing Submission with the earliest due date.

      If there are no Marketing Submissions but there is an Investigational Submission, then the system will generate the Investigational Submission.

      Investigational

      If both an Investigational Submission and a Marketing Submission would be generated, then the system will select the Investigational Submission.

      If there are multiple Investigational Submissions, the system generates the Investigational Submission with the earliest due date.

      If there are no Investigational Submissions but there is a Marketing Submission, then the system will generate the Marketing Submission.

      Marketing and Investigational The system generates the Submission with the earliest due date. If there are multiple Submissions with the earliest due date, the system selects the Submission with the earliest created registration.

      This field is only supported for Agency-type Organizations.

      Localization
      (localization__v)
      Select the Localization record 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.

    5. Select Save.

Read More


Set Up User Accounts

Vault Safety restricts user access to data by role per organization. After configuring organizations, add users and configure one or more roles for each user for the organizations that they must be able to access.

  • Add a User

    Note Vault Online Help provides more information on creating and managing users.

    1. In the Admin area, go to the Users & Groups tab and select Create Button.
    2. On the Create User page, select an existing Domain User from the picklist to auto-populate some general information fields.
    3. If a Domain User does not already exist, select the Create Domain User option from the picklist. Complete the following fields on the Create Domain User window and select Save:
      Field Description
      First Name Enter the user's first name.
      Last Name Enter the user's last name.
      User Name Enter the user's user name.
      The system formats the user name as an email address with the vault domain name. For example, if you enter john.smith in the User Name field, the system saves the user name as john.smith@domain.com.
      Email Enter the user's email address.
      Language Select the user's preferred language.
      This option controls localization options for the user (number and date formats and label language respectively).
      Locale Select the user's preferred local.
      This option controls localization options for the user (number and date formats and label language, respectively).
      Timezone Select the user's time zone.
      Vault stores time and date information in UTC (Coordinated Universal Time), but displays that information to users in their own time zones.
    4. In the Details section, complete the following fields:
      Field Description
      License Type Select the type of license to assign the user.
      Manage License Types describes license types.
      Security Profile Select the type of security profile to assign the user.
      Manage Security Profiles describes security profiles.
      Domain Admin Select this field if the user is a domain administrator.
      Security Policy (Optional) Select a password security policy for the user.
      Federated ID (Optional) To associate the user with an external user ID for single-sign-on or other system integration purposes, enter the external user ID.
      Application Licensing Select the license type for each application that the user has access to.
    5. Select Save.
    Result

    The system creates the user. View and manage the user on the Users & Groups > Vault Users page.

  • Assign User Roles by Organization
    1. Go to Admin > User Role Setup.
      The Create User Role Setup page appears.
    2. In the User field, select the user that you want to assign the role to.
    3. In the Role field, select the Application Role that you want to assign the user.
      Manage Application Roles provides information on the default application roles.
    4. In the Organization field, select the organization that the user should have access to with the application role.
    5. In the Status field, to make the Role Assignment record active, select Active. To save the Role Assignment for future use, select Inactive.
    6. Select Save.
    Result

    The user is granted access to documents and workflows for the organization, according to their application role.

Read More


Add Products

Add each product that your organization monitors and reports on to Vault Safety’s internal Product library.

  • Create a Product Record
    1. Go to Business Admin > Products.
    2. On the Products page, select Create.
    3. In the Create Product window, select the product type, and then select Continue.

      Note When you select a product type registered in the FDA's jurisdiction, the product type determines how the system automatically generates submissions to the FDA. See FDA Report Formats for more information.

    4. Complete the fields on the Create Product page.
    5. Select Save.

    Product Fields

    Field Description
    Organization
    (organization__v)

    Select the Organization to which the product belongs.

    When adding a Case Product, the Case must be associated with this organization to allow users to select this product.

    Product Name
    (name__v)

    Enter the primary name of the product. Vault Safety references the product using the name that you enter in this field.

    When a Case Product references this Product record, the system uses this field to generate the Case Product Name.

    Abbreviation
    (abbreviation__v)

    Enter the abbreviated name for the product.

    This field is for reference only.

    Generic Name
    (generic_name__v)

    Enter the generic name for the product.

    For Device-type products, this field is used in report generation for FDA E2B (R2), FDA VAERS E2B (R3), and FDA MedWatch 3500A report formats.

    Vaccine Type
    (vaccine_type__v)

    If the product is a vaccine, select the vaccine type.

    When a Vaccine-type Case Product references this Product record, the system snapshots this field to the Case Product.

    International Birthdate
    (international_birthdate__v)

    Enter the date when a regulatory authority first granted marketing authorization for the product.

    This field is used in report generation for the FDA MedWatch 3500A format (G.5 Pre-1938).

    Expiration Date
    (case_product_expiration_control__v)

    Enter the expiration date for the product. Partial dates are supported and the minimum precision required is the year.

    The system snapshots this field to the Case Product. For Device-type products, this field is used in report generation for FDA E2B (R2) (B.4.k.2.4.FDA.1).

    Manufacturer
    (manufacturer__v)

    Select the organization that manufactures the product, if it is different from the one selected in the Organization field.

    For Device-type products, this field is used in report generation for FDA E2B (R2), FDA VAERS E2B (R3), and FDA MedWatch 3500A report formats.

    Core Datasheet
    (datasheet__v)

    Select the Core Datasheet for the product family.

    Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.

    API Name
    (api_name__v)

    Enter a unique identifier that can be used with the Safety Rule "Product" parameter to define a specific Product for a reporting rule.

    To learn more, see Reporting Rule Parameter Reference.

  • Add Product Registration Details

    Add product registration details for each country the product is registered in.

    1. Go to the Product record page.
      Find Product records on the Business Admin > Products page.
    2. Under Registrations, select Create.
    3. Complete the Create Product Registration page.
    4. Select Save.

    Product Registration Fields

    Field Description
    Organization
    (organization__v)

    The system automatically populates this field with a reference link to the Organization on the Product parent record.

    The system snapshots this field to the Registration Holder field on a Case Product.

    Product
    (product__v)
    The system automatically populates this field with a reference link to the Product parent record.
    Registration Name
    (name__v)
    (Required) Enter a name for the Product Registration. Vault Safety references the registration using the name that you enter in this field.
    Product Type
    (product_type__v)
    The system automatically populates this field with the product type of the Product parent record.
    Combination Type
    (combination_type__v)

    If the product is a combination product, select the combination type.

    The system snapshots this field to the Case Product and is used in report generation for the FDA VAERS E2B (R3) format.

    Registration Number
    (registration_number__v)

    Enter the product authorization or application number for the country where the product is marketed.

    For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

    The system snapshots this field to the Case Product and is used in report generation for E2B, FDA MedWatch 3500A, and PADER formats.

    Registration Date
    (registration_date__v)

    Enter the date when the product was registered.

    This field is for reference only.

    Registration Type
    (registration_type__v)

    Select the registration type.

    This field is used in report generation for FDA MedWatch 3500A and PADER formats.

    This field is needed to correctly match Transmission Profile Scope records for any Organization which has multiple Transmission Profiles for the same destination Agency.

    Country
    (country__v)

    Select the country where the product is registered and authorized.

    The system snapshots this field to the Registration Country field on a Case Product and is used in report generation for E2B formats.

    Route of Administration
    (route_of_administration__v)

    Select the route of administration TermID code.

    This field is for reference only.

    Compounding Type
    (compounding_type__v)

    If the product is a compounded product, select the compounding type.

    The system snapshots this field to the Case Product and is used in report generation for E2B formats.

    Agency
    (agency__v)

    Based on the Country selected on the Product Registration, the system automatically populates this field with the Agency assigned jurisdiction over that country.

    If configured, reporting rules generate Submissions to this Agency when a Case Product references this Product Registration.

    Transmission Profile
    (transmission_profile__v)

    To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.

    Local Datasheet
    (datasheet__v)

    Select the Local Datasheet for this product registration. A Local Datasheet is specific to a country or region, listing expected adverse events that apply to that product registration.

    Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.

    MAH
    (reporting_organization__v)

    This field may also be named Reporting Organization depending on your vault's configuration.

    If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.

    Note Removing the last remaining MAH/Reporting Organization from an MAH Distribution List will also delete the MAH Distribution list.

    Warning Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.

    Transmission Product Type
    (transmission_product_type__v)

    Select the product type for this registration.

    The system snapshots this field when generating Transmissions for this registration, then uses that value to determine whether Device-type Combination Product Constituents are exported in E2B transmissions.

    See Exclude Device Constituents from E2B Exports for more information.

    This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

    Strength
    (strength_number__v | strength_unit__v)
    Enter the strength of the product.
    In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.
    MPID
    (mpid__v)

    Enter the Medicinal Product Identifier (MPID) for the product.

    Note You can specify only one type of product identifier. Do not specify a MPID if you have entered a PhPID.

    The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

    PhPID
    (phpid__v)

    Enter the Pharmaceutical Product Identifier (PhPID).

    Note You can specify only one type of product identifier. Do not specify a PhPID if you have entered a MPID.

    The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

    National Drug Code
    (ndc__v)

    Enter the US National Drug Code (NDC) or unique identifier for the product.

    This field is used in report generation for the FDA MedWatch 3500A format.

    Product Code
    (product_code__v)

    Enter the device Product Code.

    The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A report formats.

    Local Product Code
    (local_product_code__v)
    Enter the region-specific Medicinal Product Identification (MPID) code. This field is used for Localized Cases.
    Trade Name
    (trade_name__v)
    The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2) (B.4.k.20.FDA.1).

    PMDA Fields

    Use the PMDA section on a Product Registration to set up information for a Japanese Product Registration. Add a Japan Product Registration provides information on the PMDA fields.
  • Product Registration Fields

    Product Registration Fields

    Field Description
    Organization
    (organization__v)

    The system automatically populates this field with a reference link to the Organization on the Product parent record.

    The system snapshots this field to the Registration Holder field on a Case Product.

    Product
    (product__v)
    The system automatically populates this field with a reference link to the Product parent record.
    Registration Name
    (name__v)
    (Required) Enter a name for the Product Registration. Vault Safety references the registration using the name that you enter in this field.
    Product Type
    (product_type__v)
    The system automatically populates this field with the product type of the Product parent record.
    Combination Type
    (combination_type__v)

    If the product is a combination product, select the combination type.

    The system snapshots this field to the Case Product and is used in report generation for the FDA VAERS E2B (R3) format.

    Registration Number
    (registration_number__v)

    Enter the product authorization or application number for the country where the product is marketed.

    For U.S. Registrations, ensure that the value you enter in this field adheres to the FDA E2B format requirements for element B.4.k.4.1 (Authorisation / Application Number).

    The system snapshots this field to the Case Product and is used in report generation for E2B, FDA MedWatch 3500A, and PADER formats.

    Registration Date
    (registration_date__v)

    Enter the date when the product was registered.

    This field is for reference only.

    Registration Type
    (registration_type__v)

    Select the registration type.

    This field is used in report generation for FDA MedWatch 3500A and PADER formats.

    This field is needed to correctly match Transmission Profile Scope records for any Organization which has multiple Transmission Profiles for the same destination Agency.

    Country
    (country__v)

    Select the country where the product is registered and authorized.

    The system snapshots this field to the Registration Country field on a Case Product and is used in report generation for E2B formats.

    Route of Administration
    (route_of_administration__v)

    Select the route of administration TermID code.

    This field is for reference only.

    Compounding Type
    (compounding_type__v)

    If the product is a compounded product, select the compounding type.

    The system snapshots this field to the Case Product and is used in report generation for E2B formats.

    Agency
    (agency__v)

    Based on the Country selected on the Product Registration, the system automatically populates this field with the Agency assigned jurisdiction over that country.

    If configured, reporting rules generate Submissions to this Agency when a Case Product references this Product Registration.

    Transmission Profile
    (transmission_profile__v)

    To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.

    Local Datasheet
    (datasheet__v)

    Select the Local Datasheet for this product registration. A Local Datasheet is specific to a country or region, listing expected adverse events that apply to that product registration.

    Datasheets are used to automatically detect expectedness for an adverse event and the suspect or interacting Case Products.

    MAH
    (reporting_organization__v)

    This field may also be named Reporting Organization depending on your vault's configuration.

    If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.

    Note Removing the last remaining MAH/Reporting Organization from an MAH Distribution List will also delete the MAH Distribution list.

    Warning Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.

    Transmission Product Type
    (transmission_product_type__v)

    Select the product type for this registration.

    The system snapshots this field when generating Transmissions for this registration, then uses that value to determine whether Device-type Combination Product Constituents are exported in E2B transmissions.

    See Exclude Device Constituents from E2B Exports for more information.

    This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

    Strength
    (strength_number__v | strength_unit__v)
    Enter the strength of the product.
    In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.
    MPID
    (mpid__v)

    Enter the Medicinal Product Identifier (MPID) for the product.

    Note You can specify only one type of product identifier. Do not specify a MPID if you have entered a PhPID.

    The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

    PhPID
    (phpid__v)

    Enter the Pharmaceutical Product Identifier (PhPID).

    Note You can specify only one type of product identifier. Do not specify a PhPID if you have entered a MPID.

    The system snapshots this field to the Case Product and is used in report generation for E2B (R3) and CIOMS I formats.

    National Drug Code
    (ndc__v)

    Enter the US National Drug Code (NDC) or unique identifier for the product.

    This field is used in report generation for the FDA MedWatch 3500A format.

    Product Code
    (product_code__v)

    Enter the device Product Code.

    The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2), FDA VAERS E2B(R3), and FDA MedWatch 3500A report formats.

    Local Product Code
    (local_product_code__v)
    Enter the region-specific Medicinal Product Identification (MPID) code. This field is used for Localized Cases.
    Trade Name
    (trade_name__v)
    The system snapshots this field to Device-type Case products, and it is used in report generation for FDA E2B(R2) (B.4.k.20.FDA.1).

    PMDA Fields

    Use the PMDA section on a Product Registration to set up information for a Japanese Product Registration. Add a Japan Product Registration provides information on the PMDA fields.

Read More


Add Studies

Add a Study record for each clinical study that your organization monitors and reports on. Before you add a Study, ensure to add the Study Product to the Product library.

  • Create a Study Record
    1. Go to Business Admin > Studies.
    2. Select Create.
    3. Complete the fields on the Create Study page.
    4. Select Save.

    Study Details Fields

    Field Description
    Study Number
    (name__v)

    Enter the sponsor study number. Vault Safety references the study using the number that you enter in this field.

    The system snapshots this field to Cases linked to this Study and uses the Study Number to generate Case Names.

    This field is also used in E2B, DSUR, and FDA 3500A report generation.

    Development Phase
    (development_phase__v)

    For Studies reportable to the PMDA (Japan), select the development phase. While Vault Safety does not currently export to PMDA E2B R3, this field corresponds to data element J2.13.r.3

    If this field does not appear on the page layout, an administrator can add it as part of the steps to enable PMDA (Japan) fields.

    Study Type
    (study_type__v)

    Select the reason the patient was administered the Study Product. The following options are available, but your vault may be configured with additional options:

    • Clinical Trial: This option corresponds to E2B code 1 for data element C.5.4.
    • Individual Patient Use: For example, compassionate use, named patient basis. This option corresponds to E2B code 2 for data element C.5.4.
    • Other Study: For example, pharmacoepidemiology, pharmacoeconomics, intensive monitoring. This option corresponds to E2B code 3 for data element C.5.4.

    The system snapshots this field to Cases linked to this Study.

    This field is used to define postmarket studies for PADER, PBRER, PSUR, CIOMS I, and FDA MedWatch 3500A reports. This field is also used in E2B report generation.

    If this field does not appear on the page layout, an administrator can add it as part of the steps to enable post market studies.

    Masking
    (masking__v)

    (Required) Select the masking level required for the study.

    When this field is set to Double-Blind, you can use the Blinded field to enable blind protection.

    Start Date
    (start_date__v)

    Enter the start date for the study.

    This field is for reference only.

    Completion Date
    (completion_date__v)

    Enter the completion date for the study.

    This field is for reference only.

    Study Name
    (study_name__v)

    Enter the study name as registered in the jurisdiction where you will submit case reports.

    The system snapshots this field to Cases linked to this Study.

    This field is also used in E2B report generation.

    Organization
    (organization__v)

    Select the Organization that sponsors the study.

    When selecting the Study on a Case, the Case must be associated with this organization to allow users to select this study.

    MedDRA Version
    (meddra_version__v)

    Select the MedDRA version for the study.

    This field is for reference only.

    Note This field does not control the MedDRA Version used by Cases associated with the Study.

    Download Dosage to Case
    (download_dosage_to_case__v)

    This field only appears when the following conditions are true on the Study record:

    1. Blinded is set to Yes
    2. Study Has Arms is set to Yes

    Select one of the following options to control how the system will snapshot Study Arm Product Dosage information to Cases involving the Study:

    • When Case is Opened: Dosage information will be populated upon case promotion.
    • When Case is Unblinded: (Default) Dosage information will be populated once the Case has been unblinded.
    • Never: The system will not snapshot Study Arm Product Dosage information to Cases.
    Blinded
    (blinded__v)
    This field appears when you set the Masking field to Double-blind. The following list outlines how to set this field:
    • Blank: Leave this field blank when the study is not a double-blind study (single-blind or open).

    • Yes: Select this option when the study is a double-blind study that is still in progress. When you select Yes, the system applies blind protection to this Study and its Cases.
      Blind protection is activated after unblinding for Case products and associated assessments.

    • No: Select this option when the study is double-blind study that has been unblinded at the study completion.

    Study Has Arms
    (study_has_arms__v)
    Select Yes if the study has arms. Once you save the Study, you can add Study Arms. Select No if the study does not have arms.
    Study Has Unspecified Products
    (study_has_unspecified_products__v)
    Select this checkbox if you want to create a Study with Unspecified Products.

    This option is mostly for organized data collection of reports from non-clinical trial studies. For example, for Patient Support Programs (PSPs) and Market Research Programs (MRPs) that may not have Study information available, such as Study Products or Study Product Registrations.

    If you select this option, the system uses Product Registrations when evaluating reporting obligations for Cases involving this Study.

    The system can not save the Study if you select this checkbox for a Study that has Study Products, Study Arms, or Registrations.

    Note If you do not see this checkbox, you must add it to the Study page layout.

    Core Datasheet
    (datasheet__v)

    Select the Core Datasheet for the Study.

    Datasheets are used to automatically detect expectedness for an adverse event reported for a Study.

    API Name
    (api_name__v)

    Enter a unique identifier that can be used with the Safety Rule "Study" parameter to define a specific Study for a reporting rule.

    To learn more, see Reporting Rule Parameter Reference.

  • Add a Study Indication
    Add a Study Indication to code the MedDRA term for the medical condition relevant to the study.
    1. Go to the Study record page.
      Find Study records on the Business Admin > Studies page.
    2. Under Indications, select Create.
    3. Specify the Indication on the Create Study Indication page.
    4. Select Save.

    Study Indication Field

    Field Description
    Indication
    (indication_meddra__v)

    Enter the reported term in the text field, then use the Auto-Code button to automatically match and code the MedDRA term. Alternatively, use the binoculars icon to open the MedDRA browser.

    To learn more, see Code MedDRA Terms.

  • Add a Study Product

    Note You must add the Product to the product library before you can add a Study Product.

    1. Go to the Study to which you want to add the Study Product.
      Find Study records on the Business Admin > Studies page.
    2. Under Study Products, select Create.
    3. In the Create Study Product window, select the product type, and then select Continue.
      Select the same product type that the Product record is set to.
    4. Complete the fields on the Create Study Product page and select Save.

    Study Product Fields

    Field Description
    Organization
    (organization__v)

    The system automatically populates this field with the Organization the Study is associated with. Products must be linked to the same Organization to be selected on the Study Product.

    Study
    (study__v)
    The system automatically populates this field with the parent Study record.
    Name
    (name__v)
    Enter a name to identify the Study Product. The name should be consistent with the relevant Product Registration.
    Study Product Role
    (study_product_role__v)

    Select the role of the product in the study. If you leave this field blank, Investigational is used by default.

    The following standard options are available:

    • Investigational (Default)
    • Active Comparator
    • Placebo
    • Device
    • Diagnostic
    • Standard of Care

    This field is used to classify products in DSUR report generation.

    Product
    (product__v)
    Select the Product from the product library. Start typing the name of the product to live search the product library.
    Product Registration
    (product_registration__v)

    Select the Product Registration associated with this Study Product. The list of records is filtered by the Product selected in the Product field.

    Dose
    (dose_number__v | dose_unit__v | dose_unit_text__v)

    Enter the amount of product that is administered in each dose. In the first field, enter a numeric value. In the second field, select a unit of measurement from the picklist or enter a custom unit.

    When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

    Frequency
    (frequency__v)

    Enter a numeric value specifying the frequency of the administered dose.

    When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

    Frequency (unit)
    (frequency_unit__v)

    Select the unit of measurement specifying the frequency of the administered dose.

    When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

    Dose Form
    (dose_form__v | dose_form_text__v)

    Select the pharmaceutical dose form of the product from the picklist, or use a custom entry.

    Vault Safety supports a selection of dose form terms, including terms from the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) and the Medicines and Healthcare products Regulatory Agency (MHRA).

    For open-label and single-blinded Studies and Study Arms, the system snapshots this field to Cases upon Case promotion.

    When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

    RoA
    (roa__v | roa_text__v)

    Select the route of administration of the product from the picklist or enter a custom entry.

    For open-label and single-blinded Studies and Study Arms, the system snapshots this field to Cases upon Case promotion.

    When a blinded Study Arm Product references this Study Product, the system snapshots this field to Cases in accordance with the Download Dosage to Case setting on the Study.

    Dosage Notes
    (dosage_notes__v)

    (Optional) Enter any additional notes about the dose.

    This field is for reference only.

  • Add Study Registration Details
    Add a Study Registration for each country the study is registered in. When a Case Report Type is Study, the system looks at the Study Registration Countries to generate Submissions according to reporting rules in your vault. Understand the Reporting Rules Engine provides more information.
    1. Go to the Study record page.
      Find Study records on the Business Admin > Studies page.
    2. Under Registrations, select Create.
    3. Complete the fields on the Create Study Registration page.
    4. Select Save.

    Study Registration Fields

    Field Description
    Organization
    (organization__v)

    The system automatically populates this field with a reference link to the Organization on the Product parent record.

    The system snapshots this field to the Registration Holder field on a Case Product.

    Study
    (study__v)
    The system automatically populates this field with a reference link to the Study parent record.
    Registration Number
    (registration_number__v)

    Enter the study identifier assigned by the registry.

    Country
    (country__v)

    (Required) Select the country where the product is registered and authorized.

    Reporting Organization
    (reporting_organization__v)

    This field may also be named MAH depending on your vault's configuration.

    If you have a Marketing Authorization Holder (MAH) that manages your ICSR reporting obligations for this registration, select the Organization. Selecting an Organization in this field creates an MAH Distribution List, and thereby a reporting obligation, for this registration.

    Warning Use caution when setting this field. Reporting Obligations are for Distributions only and override agency submission rules. Do not select an Agency such as the FDA or EMA.

    Registration Type
    (registration_type__v)

    Select the registration type.

    This field is used in report generation for FDA MedWatch 3500A and PADER formats.

    This field is needed to correctly match Transmission Profile Scope records for any Organization which has multiple Transmission Profiles for the same destination Agency.

    Transmission Profile
    (transmission_profile__v)

    To specify the Transmission Profile the system should use when automatically generating Submissions for this registration, select the Transmission Profile. We recommend setting this field when you have a Transmission Profile corresponding to this reporting destination and report type.

    Transmission Product Type
    (transmission_product_type__v)

    Select the product type for this registration.

    The system snapshots this field when generating Transmissions for this registration, then uses that value to determine whether Device-type Combination Product Constituents are exported in E2B transmissions.

    See Exclude Device Constituents from E2B Exports for more information.

    This field does not appear on page layouts by default, but can be added to Transmission page layouts by an administrator.

  • Add a Study Site

    For multisite clinical studies, create a Study Site record for each site. Study Sites are linked with Site-type Organization records.

    1. Go to the Study to which you want to add a Study Site.
      Find Study records on the Business Admin > Studies page.
    2. Under Study Sites, select Create. The Create Study Site page appears.
    3. Complete the fields on the Create Study Site page.
    4. Select Save.

    Study Site Fields

    Field Description
    Organization
    (organization__v)

    The system automatically populates this field with a reference link to the Organization on the Product parent record.

    The system snapshots this field to the Registration Holder field on a Case Product.

    Study
    (study__v)
    The system automatically populates this field with a reference link to the Study parent record.
    Study Site Number
    (name__v)
    Select the Study Site with which this Study Person should be associated. When performing intake, users must select this Study Site to be able to select this Study Person on an AER.
    Registration
    (registration__v)
    Select the Study Registration associated with this Study Site.
    Site
    (site__v)

    To specify the site, perform one of the following actions:

    • If the Site-type Organization has already been added, select the record from the list or select the binoculars to open the browser.
    • If a Site-type Organization has not been added, create one:
      1. Click into the field, and then select Create Organization from the drop-down.
      2. In the Create Organization window, select Site as the Organization Type, and then select Continue.
      3. In the Create Site window, enter the name and address of the Study Site.
      4. Select Save.

Read More


Set Up Aggregate Reporting Families

To enable aggregate report authoring in Vault Safety, you must set up the Reporting Family. The Reporting Family defines which Products and Studies to include in an aggregate report and the reporting time period.

  • Create an Aggregate Reporting Family

    Note The Base Reporting Family object type is deprecated and should not be used for aggregate reporting. We recommend that all aggregate reporting families be of the type Product Family. This recommendation applies both to creating new aggregate report tabulations and re-generating tabulations on existing aggregate reports already setup in the system.

    1. From the Business Admin tab, go to Reporting Families.
    2. Select Create.
    3. In the Create Reporting Family window, select Product Family, and then select Continue.
    4. Complete the following fields on the Create Reporting Family page:
      Field Description
      Name Enter a name for the product family.

      Note If your organization uses Reporting Families for aggregate reporting, we recommend that product family names have a maximum of 75 characters. Longer names may impact report generation.

      Organization Select the organization that is responsible for preparing the report.
      IBD Select the international birth date (IBD) for the product family. This field is informational only, and is not used in aggregate reporting.
      Reporting Period (Months) Enter the number of months that the reporting period spans. The time period you enter in this field determines the reporting schedule the system uses to automatically generate subsequent aggregate reports when the Generate Next Aggregate Report Record action is triggered.
    5. Select Save.
  • Add Products to the Reporting Family
    1. On the reporting family page, expand Products.
    2. Select Create.
      The Create Reporting Family Member window appears.
    3. In the Product field, select the Product to include in the report.
      The products that appear are filtered by the organization.
    4. Select Save.

    Result

    The Product is added to the Reporting Family. Any Studies associated with the Product are also added to the Reporting Family. Add additional Products as required.

  • Add Studies to the Reporting Family

    If the report must include a Study Product that does not share registration details with a record in the Product library, add the Study.

    1. On the Reporting Family page, expand Studies.
    2. Select Create.
      The Create Reporting Family Member window appears.
    3. In the Study field, select the Study to include in the report.
      The studies that appear are filtered by the organization.
    4. Select Save.

    Result

    The Study and associated Products are added to the Reporting Family. Add additional Studies as required.

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