Create a Distribution

Create a Distribution to share a case with a partner organization.

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Creating Distributions

Distributions can be created automatically during Case workflows, or manually.

The Distribution workflow depends on your vault configuration. By default, after a Distribution is created, Vault Safety assigns a task to users in the Distribution Manager role to review and approve the Transmission and Individual Case Safety Report (ICSR) document before transmitting the Distribution.

Prerequisites

  • An administrator must have already configured the Transmission Profile for the trading partner. The Transmission Profile may be one of the following types for Distributions:
  • To automatically generate Distributions, an administrator must configure Partner Distribution Rules.
  • You must have permissions to manage Transmission object records. Typically, these permissions are reserved for Distribution Manager users.

Automatic Creation

Vault Safety automatically creates Distribution records when the Evaluate Reporting Obligations action runs on the Case. By default, when a Case enters the Approved state, the system creates any necessary Distributions.

Note When Submissions are generated for a Domestic Case, the system automatically links any Localized Cases for countries within the reporting jurisdiction.

Regenerate Automatically Created Distributions

To prevent duplicate Distribution records, if Case details are changed, Vault Safety only regenerates a Distribution record if one does not already exist for the same Transmission Profile.

To regenerate a Distribution record to replace one that already exists, mark the Distribution record inactive, and then trigger the Evaluate Reporting Obligations action, for example, by moving the Case back to the Approved state.

Automatic Creation of Masked Distributions

For Cases linked to a Study or Product Family with a Partner Distribution Rule set up with content protection, when the Case enters the Approved state, Vault Safety automatically generates Distributions with data masking.

The name of the generated Distribution includes a prefix that identifies the masking option:

  • Mask PII: Distributions generated with Patient Content Protection set to Mask PII.
  • Mask E2B (Includes PII): Distributions generated with Patient Content Protection set to Mask E2B (Includes PII).
  • Blinded: Distribution generated with Study Content Protection set to Mask Unblinded Content.

Manual Creation

While the system automatically creates Distribution, you can manually create Distributions for ad-hoc reporting, such as amendments or nullifications.

Create a Distribution

  1. On the Case that you want to distribute, expand the Transmissions section, and then select Create.
  2. In the Create Transmission window, select Distribution, and then select Continue.
  3. Complete the fields on the Create Distribution page, as required.
    Distribution Fields provides more information.
  4. Select Save.

Result

The system creates the Distribution and creates a Review Submission task for users in the Distribution Manager role.

Distribution Fields

Field Description
Origin Select the organization set up as Vault Customer (vault_customer__v) for your vault.
If you select the Transmission Profile, this field is automatically populated.
Destination Select the destination to direct the ICSR.
If you select the Transmission Profile, this field is automatically populated.
Transmission Profile Select the Transmission Profile configured for trading ICSRs with the partner.
Transmission Document Type Select ICSR document format to generate for the transmission.
For Gateway Transmissions, select an E2B format. Generate a Regulatory Report provides more information on the supported formats.
Sender (User) If an administrator has configured the Transmission Profile to populate this field with a default Sender User, this field is automatically populated in the system generated transmission.

If this field is left blank on the Transmission Profile, it will be populated with the user assigned the Head of Safety sharing role.

Due Date If an administrator has configured reporting rules for distributions, the Distribution due date is automatically generated.
Reason Select the reason for sending this ICSR to the destination Gateway.
You can select one of the following options:
  • Initial: The first submission of the case.
  • Amendment: An amendment to a prior submission.
  • Follow-Up: A follow-up case.
  • Nullification: Submission of a case to report it as nullified.
Reason Text For nullification and amendments only, enter more information about the submission reason.
Follow-up Number For follow-ups only, enter the follow-up number.
Organization The system automatically populates this field when you create a Transmission from a Case.
E2B Message ID Message ID to use in the E2B message header. The system automatically populates this field with a message ID when the Submit to Gateway action is triggered.
Destination Case ID The system automatically populates this field upon receipt of the final acknowledgment (ACK) when you export E2B Submissions.
Transmission Date The date of transmission. The system automatically populates this field with time and date of submission when the Submit to Gateway action is triggered.
Auto-Submit Select Yes to enable automatic Transmissions directly from the Case.

Leave this field blank to require users to trigger the Transmission manually from the Submission or Distribution record. An administrator may need to configure this field to appear in your vault.

Auto-Submissions provides more information.

Safety Report Version

The version of the safety report. This field populates the <safetyreportversion> tag in E2B (R2) exports. The default value is taken from the Version field on the Case. This field has a two-character limit.

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

Transmission Product Type

Select the product type classification for generating the ICSR document.

For Combination Product reports, the value in this field determines whether Device-type Product Constituents are exported in the E2B file. If this field is left blank or set to Combination Product, the device constituents are exported. Otherwise, only non-device Product Constituents are exported to the E2B file.

See Exclude Device Constituents from E2B Exports for more information.

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.

Next Steps to Complete the Transmission

Once you have created the Submission record, you can proceed with handling the transmission using one of the following methods, depending on the type of Transmission Profile being used:


Create a Submission
Auto-Submissions
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