Migrating Data to Veeva Submissions

The primary use case for a Veeva Submissions migration is a legacy migration. A Submissions migration commonly involves migrating data, correspondence documents and source documents. This guide covers the most common aspects of migrating data and documents to a Submissions Vault.

Migrating Submissions Data

The RIM product model offers some flexibility with the RIM objects that are typically populated, which are used by the application and any associated documents. For Veeva Submissions customers, these objects consist of the core product hierarchy, core study data, and application objects.

In addition, consider the following objects:

Site (clinical_site__v)
Therapeutic Indication (therapeutic_indication__v)

Special consideration should be given when migrating into the objects Application, Regulatory Objective, Submission, and Health Authority Interaction.

Considerations

Application

Each Application record contains a superset of all information regarding a request made to a Health Authority for approval. This approval is necessary to market a product or conduct a trial in a particular country or region that falls under that Health Authority’s jurisdiction.

You should give special consideration when populating the following Application object fields:

Region: This field is required and used to constrain the Lead Market and Application Type values available.
Lead Market: This field is required, constrained by the selected Region, and used to constrain the Application Type values available.
Application Folder Name: This field is auto-defaulted and optional, but has a downstream effect on Veeva Submissions, Publishing and Submissions Archive processes by allowing users to successfully navigate links in Submissions Archive documents that are targeted within or across applications.
Application Type: This field is required and if incorrectly provided, will not constrain the Submission Type on a Submissions page to the correct list, as they are limited by regional constraints.
Content Plan Template: This field defines the submission structure used to assemble, publish, and submit documents to the Health Authority under this Application. When populated on an Application, this value is defaulted on subsequent Submissions.
Dossier Format: This field is required to upload a sequence into Veeva Submissions Archive and determine how a Submission is published with Submissions Publishing. When populated on an Application, this value is defaulted on subsequent child Submissions.
Procedure Type: When applicable, this field is used to drive functionality unique to a specific procedure, such as Centralised Procedure.
Enable Active Dossier Generation: This field determines whether a submission's documents are tracked in the Active Dossier.
Active Dossier Template: When applicable, this field indicates the Active Dossier hierarchy in which a submission's documents should appear.

After you have created an Application record, you should associate it with the other reference records by creating the appropriate Application detail records:

Application Countries
Application Contact
Application Product Families
Application Products
Application Pharmaceutical Forms (only for Swiss Applications)
Application Active Substances
Application Inactive Ingredients
Application Indications
Application Clinical Study
Application Nonclinical Study
Application Extended eCTD Keywords (for eCTD 4.0)
Application Organization
Application Site Contact
Application Site Role
Application Packaging*
Application Shelf Life or Condition*
Application Product Characteristic*
Application Packaging Characteristic*
Application Authorization*
Application Nomenclature Code*
Application Regulatory Text*
Related Application

* These details are not necessary for Veeva Submissions, but are used for Registrations.

The usage of several Application detail objects is dependent on the Enable Application Relationships application setting. These detail records will be reused in future Regulatory Objectives and Submissions using the Submission Wizard. You should review and plan any relationships to prepare for the use of the Submission Wizard for Publishing.

Regulatory Objective

Regulatory Objectives identify goals for active and future registration data, group submissions that were sent to the Health Authority to achieve similar goals, and track approval of these goals. These objectives are a prerequisite for Veeva Registrations and Active Dossier functionality and also support the automation of many activities across the Veeva RIM application family.

You should give special consideration when populating the following Regulatory Objective fields:

Lifecycle State: This field defines what state the Regulatory Objective is in.
Planned Approval/Authorization Date: This field determines when a Health Authority approval is anticipated, but is not critical for previously approved products.
Actual Decision Date: This field determines when a Health Authority has completed their approval and is required if using the Chronology report. However, this field is not required for previously approved products.

After you have created the Regulatory Objective record, you should associate it with the other reference records by creating the appropriate Regulatory Objective detail records:

Regulatory Objective Products
Regulatory Objective Active Substances
Regulatory Objective Inactive Ingredients
Regulatory Objective Indications
Regulatory Objective Clinical Study
Regulatory Objective Nonclinical Study
Reg Objective Extended eCTD Keywords (for eCTD 4.0)
Regulatory Objective Organization
Regulatory Objective Site Contact
Regulatory Objective Site Role
Regulatory Objective Packaging*
Regulatory Objective Shelf Life or Condition*
Regulatory Objective Authorization*
Regulatory Objective Nomenclature Code*
Regulatory Objective Regulatory Text*
Application Regulatory Objectives

* These details are not necessary for Veeva Submissions, but are used for Registrations.

These detail records are most important for the planned and in-progress Regulatory Objectives you plan to work with after the migration. You should populate the Application Source field on applicable detail records to reference their corresponding Application detail for the Submission Wizard to enforce control as intended.

Before creating Submission records, you should understand the relationship between the Submission Type and Application Type, as the Application Type value constrains the Submission Type values.

You should give special consideration when populating the following Submission fields:

Dossier Format: This field, when populated, is an entry criteria on the In Progress lifecycle state, and thus Archived state (for Veeva Submissions Archive). It’s also required to upload a sequence into Submission Archive and determine how a submission is published with Submissions Publishing.
Sequence ID: This field is required for the Submission to enter the Sent to Health Authority lifecycle state. Depending on the Applicable Product Type value, it will not allow a sequence to be imported into Submission Archive.
Planned Submission Date: This field is required for the Submission to enter the In Progress lifecycle state and is only important for upcoming and in-flight Submissions.
Actual Submission Date: This field is required for the Submission to enter the Sent to Health Authority lifecycle state, preventing the record's advancement to the Archived state.
Submission Type: This field is constrained by the Application Type.
Submission Sub Type: This field is optional and constrained by the Submission Type.

After you have created the Submission record, you should associate it with the other reference records by creating the appropriate detail records. Without them, it would restrict the ability to correctly generate Submission Content Plans and prevent some of the wizards (specifically the Create Registrations wizard) from running. These Submission detail records are:

Submission Countries
Submission Languages
Submission Contact
Submission Products
Submission Pharmaceutical Forms (only for Swiss Applications)
Submission Active Substances
Submission Inactive Ingredients
Submission Indications
Submission Clinical Study
Submission Nonclinical Study
Submission Extended eCTD Keywords (eCTD 4.0)
Submission Organization
Submission Site Contact
Submission Site Role
Submission Regulatory Objective
Submission Packaging*
Submission Shelf Life or Condition*
Submission Product Characteristic*
Submission Packaging Characteristic*
Submission Authorization*
Submission Nomenclature Code*
Submission Regulatory Text*
Related Submission

* These details are not necessary for Veeva Submissions, but are used for Registrations.

These detail records are most important for the planned and in-progress Submissions you plan to work with after the migration. You should populate the Application Source field on applicable detail records to reference their corresponding Application detail for the Submission Wizard to enforce control as intended.

For a customer with Veeva Publishing, ensure Submissions are migrated into the Planned state.

Typically, Submissions are migrated into the Planned state and are moved through the Submissions lifecycle as needed. This is most relevant when importing Submissions for archive. It will be necessary to fire off any entry actions as the records move through their states. Bulk actions can be used to move all or many submissions to the appropriate end states, such as Archived or HA Received.

State changes should take place after any submission archives are imported.

Health Authority Interaction

For Health Authority Interactions, we recommend creating records for the following objects to help drive searchability and reporting on previous questions and commitments:

Health Authority Questions
Commitments
Health Authority Meetings (optional)
Correspondence Documents

After you have created the Health Authority Questions, Commitments, and Health Authority Meetings records you should associate them with the other reference records by creating the appropriate Health Authority Interaction detail records:

HA Question Product Family
HA Question Application
HA Question Reg Objective
HA Question Submission
HA Question Commitment
Commitment Clinical Study
Commitment Nonclinical Study
Commitment Application
Commitment Regulatory Objective
Commitment Submission
HA Meeting Product Family (optional)
HA Meeting Regulatory Objective (optional)
HA Meeting Clinical Study (optional)
HA Meeting Commitment (optional)
HA Meeting HAQ (optional)

Submissions Document Migration

To migrate documents, you must review your particular submission documents and map them to the most appropriate Type > Subtype > Classification in Veeva RIM. For each document type, you have the option to associate it with existing object data by setting applicable object fields.

Clinical Document Objects:
- Clinical Study, Clinical Site, Product Family, Therapeutic Indication
Nonclinical Document Objects:
- Nonclinical Study, Product Family
Quality Document Objects:
- Product Family, Active Substance, Manufacturer, Product, Product Variant, Inactive Ingredient
Regulatory Document Objects:
- Applications, Submissions, Product Family, Country, Health Authority Questions, Commitments, Regulatory Objectives
Labeling Document Objects:
- Applications, Submissions, Product Family, Products
Pharmacovigilance Document Objects:
- Product Family
Literature Reference Objects:
- Product Family