The Submission Wizard guides you through creating Submissions, Regulatory Objectives, and their relationships based upon the related Application.
Note: This feature is available for all RIM Vaults. See RIM Application Settings & Configuration Options for enablement details.
About the Submission Wizard
Submissions and Regulatory Objectives are core RIM objects which drive the creation and management of Registrations, Content Plans, XML generation during publishing, and filtering in the Submissions Archive Viewer.
A record’s scope is determined by the numerous Submission and Regulatory Objective relationship records containing metadata, such as Submission Clinical Study and Regulatory Objective Clinical Study. These relationship records are a subset of the Application relationship records (for example, Application Clinical Study), which collectively contain all Application metadata to be used in a related Submission or Regulatory Objective.
The Submission Wizard streamlines the process of defining the Submission and Regulatory Objective records and their relationships by allowing users to select from a controlled list of Application relationships, which Vault copies to the selected Submission or Regulatory Objective. This improves the data quality and data consistency of these records.
Using the Submission Wizard
You can launch the Submission Wizard from an Application, Submission, or Regulatory Objective record. You also have the option to create a Submission or Regulatory Objective within the wizard prior to selecting the relationships to add to these records.
To manage relationships from an application, submission, or regulatory objective:
- Navigate to an Application, Submission, or Regulatory Objective record.
- In the Actions menu, select + Submission Wizard. Vault launches the wizard to the Start page.
- Select or create a Submission. When you launch the wizard from a Regulatory Objective, this selection is optional. If you do not make a selection, the selected relationships are copied to the Regulatory Objective only.
- Optional: Select or create a Regulatory Objective.
- Select one or more Relationships. Vault displays all relationships to which you have permission, and for which at least one record exists for that relationship on the current Application.
- Click Next.
- Begin to Define Relationships selected in the wizard by checking the box next to each record you wish to add to the Submission and/or Regulatory Objective. Vault also pre-selects the records defined for the selected Regulatory Objective records for you. When complete, click Next. Repeat for each relationship page.
- Once you have defined all relationships, click Save. Vault begins processing the request. When finished, you’ll receive a Vault notification and email with request details and a link to the output file.
When configured by an Admin, you can override the Submission Pharmaceutical Form Name field value with its XML equivalent to accommodate scenarios where the module value is different from the XML envelope value. See Working with CH Regulatory Submissions for more information.
To view the XML value overriding the Submission Pharmaceutical Form Name in the wizard, add a column for the XML Submission Pharmaceutical Form Name field.
Managing Submission and Regulatory Objective Relationships
About the Application Source Field
The Application Source field within the Submission and Regulatory Objective relationship objects maps records to the Application relationship records from which they were created. When the Enable Application Relationships and Enable Relationship Triggers admin settings are enabled, any updates to the Application Source field will trigger Vault to update the relationship record fields mapped to the indicated Application Source, maintaining data consistency across the object records.
Once the Enable Application Relationships admin setting is enabled, Vault updates Submission and Regulatory Objective relationship object fields to be system-managed. This restricted editability enforces data consistency by requiring any updates to be made to the Application relationship, or by changing the Application Source value to the record which contains the correct values. Then, Vault copies these values to the applicable Submission or Regulatory Objective relationship record.
Sample Use Case
Wonderdrug’s RIM Vault contains the below records and metadata:
For Application Clinical Study:
|Application Clinical Study Name||Application||Clinical Study||Clinical Study Type||Clinical Study Subtype|
|CS-12345-01||EU Wonderdrug MAA||12345||Pharmacodynamics||Healthy Subject PD and PK/PD|
|CS-12345-02||EU Wonderdrug MAA||12345||Safety||Patient PK and Initial Tolerability|
For Submission Clinical Study:
|Submission Clinical Study Name||Submission||Clinical Study||Clinical Study Type||Clinical Study Subtype||Application Source|
|12345||0010 - New indication||12345||Pharmacodynamics||Healthy Subject PD and PK/PD||CS-12345-01|
A user sees that the Submission Clinical Study record’s Clinical Study Type and Subtype should be “Safety” and “Patient PK and Initial Tolerability”, respectively. Since Wonderdrug’s RIM Vault Admin has enabled the Submission Wizard and these fields are no longer directly editable, the user can leverage the Submission Wizard, or change the Application Source field value to make the update.
The user’s permission set allows them to delete the Submission Clinical Study record and, using the Submission Wizard, add the correct Application relationship record to the submission.
However, the user opts to update the Submission Clinical Study record’s Application Source field value from “CS-12345-01” to “CS-12345-02”.
This results in the following metadata:
|Submission Clinical Study Name||Submission||Application Source||Clinical Study||Clinical Study Type||Clinical Study Subtype|
|12345||0010 - New indication||CS-12345-02||12345||Safety||Patient PK and Initial Intolerability|
As the submission has an existing Content Plan, the user also:
- Re-creates the related study section within the Content Plan.
- Updates the Clinical Study Type and Subtype fields for the Content Plan records in the new section using a bulk action.
Managing Application Relationships
When the Enable Application Relationships, Enable Relationship Triggers, and the Exclude Submission Lifecycle States settings are enabled, the following Vault behavior applies to Application relationship record creation and update:
- Duplicate records within an Application are not allowed, and only one unique relationship record can be created per Application.
- Application relationship records referenced as the Application Source of a Submission relationship record cannot be edited or deleted while the Submission is in a lifecycle state configured within the Exclude Submission Lifecycle States setting. When an Application relationship record is Superseded or Withdrawn, Veeva recommends inactivating the record and creating a new one with the updated details.
- Vault copies changes made to an Application relationship record to the Submission and Regulatory Objective relationship records which reference that record as the Application Source. This behavior applies only when the Application record’s related Submission is not restricted by its lifecycle state as configured in the Exclude Submission Lifecycle State setting.
Generally, you must have a permission set with Read permission on the Application object and its relationships, in addition to the ability to Create object records of the relevant Submission object types. See Submission Wizard Administration for more information.