Manage Partner Distribution Lists

Set up Partner Distribution Rules for Vault Safety to automatically generate and assign Case Distributions.

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About Partner Distribution Lists

A Partner Distribution List is a type of Reporting Family that admins can configure to automatically generate Distributions for each partner or site with which you must transmit ICSRs.

When you create a Partner Distribution List, you specify the Origin and Destination pair. You must assign a Reporting Rule Set, which defines the Reporting Rules, or scenarios, for which a Distribution is generated and the due date. Once you save the Partner Distribution List, you can add Reporting Family Members to specify the Products, Studies, and Registrations to which the list applies.

The following illustration shows how Vault Safety evaluates a Partner Distribution List:

Evaluating Partner Distribution Rules for a Case
Evaluating Partner Distribution Rules for a Case
  • 1Case 00245 is entered and approved. The Case contains the primary Case Product Cholecap. The Case triggers the reporting rules engine by moving to the Approved state.
  • 2The primary Case Product Cholecap is part of a preconfigured Partner Distribution Reporting Family with a Destination Organization of Partner A.
  • 3The Partner Distribution Reporting Family is assigned a custom Parter ICSR Rule Set (provisioned by Veeva Support), which the reporting rules engine uses to match the Case with the appropriate reporting rule and create the Distribution.
  • 4The system generates a Distribution record for the Case and populates the due date and other fields on the Submission according to the reporting rule. The system generates the transmission document in the appropriate format, based on the Transmission Profile for the origin-destination pair.

Prerequisites

  • You must be an administrator to manage Partner Distribution Lists.
  • You must have already configured any Products, Studies, and Registrations for which the Distribution Rule will apply.
  • You must have already configured a Transmission Profile for the origin and destination pair.
    You can configure one of the following types of Transmission Profile:
  • To use the most conservative product selection when evaluating reporting rules for a Partner Distribution List, you must configure the product selection on the rule set.

    Note the following considerations for using the Most Conservative Product evaluation method in a Partner Distribution List:

    If the Case is matched by... Then the most conservative Case Assessment is selected by...
    • Study,
    • Study Registration
    Querying all Case Products for the most conservative1 Case Assessment.
    • Product,
    • Product Registration
    Querying only Case Assessments linked with Case Products defined in the Partner Distribution List.
    1. The definition of most conservative is described on the Configure Reporting Rules Product Selection page.

Create a Partner Distribution Rule

  1. Go to Business Admin > Reporting Families.
  2. On the Reporting Families page, select Create.
  3. In the Create Reporting Family window, select Partner Distributions, and then select Next.
  4. On the Create Partner Distributions page, complete the following fields:
    Field Description
    Name Enter a name for the Partner Distribution List.
    Organization Select the origin Organization that will coordinate outgoing Distribution.
    Destination Organization Select the destination Organization that will receive the Distribution.
    Distribution Rules Select which Reporting Rule Set to assign to this Distribution Rule.
    Reporting Rule Sets provides more information on the available rule sets. You can change the assigned rule set at any time after you create the Partner Distribution Rule.
    Patient Content Protection (Optional) To mask patient data in distributions, select a masking option.
    Mask Personal Identifiable Information (PII) describes the data masked by each option.
    Study Content Protection (Optional) To protect unblinded study data in distributions, select Mask Unblinded Content.
    Study Content Protection describes the data masked by this option.
    Exceptions to Patient Content Protection (Optional) To leave certain information unmasked when using Patient Content Protection, select one or more fields to unmask.
    Exceptions to Patient Content Protection describes the data unmasked by this option.
  5. Save the record.

Next Steps

To indicate when Vault Safety should apply this ruleset, add Reporting Family Members.

Add Reporting Family Members

Once you have created a Partner Distribution Rule, add Reporting Family Members to specify which Studies, Products, and Registrations this rule applies to.

  • Study: Apply the Distribution Rule when a Case is linked to the Study. This includes all registrations under the Study.
  • Study Registration: Apply the Distribution Rule when a Case is linked to the Study and includes the specific Study Registration.
  • Product: Apply the Distribution Rule when a Case Product links to this Product. This includes all registrations under the Product.
  • Product Registration: Apply the Distribution Rule when a Case Product links to this Product Registration.

Add Study

  1. On the Partner Distribution page, expand Studies for Distribution, and then select Create.
  2. In the Create Reporting Family Member window, select Study.
  3. In the Study field, select the Study that you want to apply the ruleset to.
    The system populates the Organization and Reporting Organization fields automatically.
  4. Select Save.

Add Study Registration

Note The system generates a Distribution to the target organization regardless of the registration country on the Case Product or Study Registration.

  1. On the Partner Distribution page, expand Studies for Distribution, and then select Create.
  2. In the Create Reporting Family Member window, select Study Registration.
  3. On the Create Study Registration page, complete the following fields:
    • Study: Select the Study
    • Study Registration: Select the Study Registration for which you want to apply the ruleset.
    The system populates the Organization and Reporting Organization fields automatically.
  4. Select Save.

Add Product

  1. On the Partner Distribution page, expand Products for Distribution, and then select Create.
  2. In the Create Reporting Family Member window, select Product.
  3. In the Product field, select the Product for which you want to apply the ruleset.
    The system populates the Organization and Reporting Organization fields automatically.
  4. Select Save.

Add Product Registration

Note The system generates a Distribution to the target organization regardless of the registration country on the Case Product or Study Registration.

  1. On the Partner Distribution page, expand Products for Distribution, and then select Create.
  2. In the Create Reporting Family Member window, select Product Registration.
  3. On the Create Product Registration page, complete the following fields:
    • Product: Select the Product.
    • Product Registration: Select the Product Registration for which you want to apply the ruleset.
    The system populates the Organization and Reporting Organization fields automatically.
  4. Select Save.

Assign a Rule Set to an Agency
Manage MAH Distribution Lists
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