About Active Dossiers (RIM)

The Active Dossier structure in RIM Submissions and RIM Submissions Archive Vaults helps sponsors maintain a list of current documents for a given product and market. Vault automatically populates the Active Dossier structure for a given submission, and calculates the current status for a regulatory objective and its related submissions based on source content in your Vault. In countries where submissions must be provided to the Health Authority in the local language, Vault also includes the translation source files in the Active Dossier structure. For Vaults which also have RIM Registrations licensed, Vault automatically populates the Active Dossier structure and calculates the current status when a Global Content Plan is dispatched.

You can use the Active Dossier Viewer to see content that is currently approved and the Active Dossier Editor to add new documents directly into the hierarchy. See Working with Active Dossiers for more information.

Active Dossier Objects

The following objects support the Active Dossier and capture the structure, product-related metadata, and the status of a specific document within a given market or country:

  • Active Dossier Template contains the outline of the Active Dossier. Active Dossier Template records are provisioned and maintained by Veeva. Users can only edit the Status and Document Type fields on these records. Vault supports Active Dossier Template records for Quality (M3) documents only.
  • Active Dossier Structure contains the outline of the Active Dossier with corresponding metadata based on the Active Dossier Template. Vault creates these records automatically based on unique combinations related object reference fields, for example, a unique combination of Active Substance and Manufacturer.
  • Active Dossier Item captures each individual document and version and the current state of the document per country, as well as the metadata related to the document. Users cannot edit the Country field or any fields related to the document.
  • Active Dossier Item Detail is a child object of Active Dossier Item that captures the in-progress status of the document in a specific country. Users cannot edit the Country field or any fields related to the document.
  • Active Dossier Loader is a raw object available for creating Active Dossier records for migration purposes. To expedite the initial migration to use Active Dossier, Admins can use Vault Loader to load records of this object to quickly create Active Dossier Item, Active Dossier Item Detail, and Active Dossier Structure records in bulk. See Active Dossier Configuration for more information.

About the Active Dossier

Vault represents the Active Dossier structure in a common dossier format based on the specified Active Dossier Template. Sections within the template relate to source document types in Vault that are relevant for the Active Dossier. Vault automatically creates and populates the Active Dossier Structure based on changes to Submission and Regulatory Objective records.

Submissions Archive Source Document Detection

Vault automatically populates the Active Dossier with documents based on source content in your Vault. When you import a submission, Vault creates a Source References relationship between the source document and the Submissions Archive-type document when the file’s checksum matches. If an active Content Plan Item record in the submission content plan has a Published Output Location that corresponds to a file location in the current import, Vault uses the matched document as the source for the Submissions Archive-type document as well.

How Vault Creates & Updates the Active Dossier

When a Submission record enters the Health Authority Received state, Vault automatically creates the Active Dossier structure based on the source documents and document types within Submissions Archive and matched documents from Submission Content Plans. If a source document’s type corresponds to a document type defined in the Active Dossier Template, Vault includes the document in the Active Dossier.

Vault creates and updates records asynchronously. When a candidate document is available in both Submissions Archive and the Submission Content Plan, Vault prioritizes adding the Submissions Archive document.

From a Global Content Plan Dispatch

When creating or updating the Active Dossier from a Global Content Plan dispatch, Vault:

  • Retrieves the relevant active Activities related to the Event with a Local Disposition value that is configured in one of the disposition categories on the Global Content Plan dispatch user action.
    • Records are created per Activity, and are set with the Related Application, Regulatory Objective, and Related Submission values on the Activity
    • Records are only created for Activities where the Global Content Plan was successfully dispatched to create a Submission Content Plan or comparison for the target submission. Currently, Vault does not create records when there is no target Submission, or the dispatch skips a target Activity if, for example, they are set with a Local Disposition of “No Action” or “Not Applicable”.
  • For each relevant Activity, only considers documents matched to Global Content Plan Items or Content Plan sections that meet the following criteria:
    • Document Set is blank, or the selected value matches the Document Set on the Activity.
    • Lead Market Country and Region are blank, or the selected value matches the Impacted Market or the Impacted Market’s region on the Activity
    • The matched document appears within a section that is within the dispatch scope.
    • An active Content Plan Item does not have a “Delete” XML Operation value.
    • If Copy Relationships is disabled for the dispatch, only documents within sections referencing Submission Product, Submission Active Substance, and Submission Inactive Ingredient relationships that exist on the target Submission’s relationships are considered.
    • If Ignore Content Plan Template Constraints is disabled for the dispatch, only documents matched to records that are not excluded by template constraints on the target submission are included.
  • Retrieves the relevant active Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship records from the Global Submission to create corresponding Active Dossier Structure records based on the Active Dossier Template
  • Retrieves the source document based on the matched documents in each Content Plan Item in the Submission Content Plan. Matched documents must be version locked on the Content Plan Item to be considered.
  • Creates the Active Dossier Item record based on the metadata from the Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship record referenced on the Content Plan where the document is used.
    • For documents within Content Plan sections that do not have a Submission Product, Submission Active Substance, or Submission Inactive Ingredient defined, records are created based on matching values between the document’s Product Family and the Application’s associated Product Families.
  • Records are created in either “Pending Current” or “Dispatched” status, depending on the Activity’s Local Disposition.
    • For records created in “Pending Current”, Vault performs a calculation using the document version tree to set Active Dossier Item Details for older versions to Pending Superseded (if Current) or blank (if Pending Current or Dispatched). If there is a later version of the document to be proposed as Pending Current that is already Current or Pending Current, the Active Dossier status of the earlier version is cleared instead of being set to Pending Current. The Originates From relationship allows you to relate the documents that the current document version should replace/supersede in the Active Dossier.
    • Documents that have been dispatched but not submitted are set to Dispatched, Not Submitted.

The diagram below provides a high-level illustration of how Vault sets Active Dossier Item Detail record fields according to the dispatched Activity’s Local Disposition field.

active dossier from GCP dispatch flow

From Submissions Archive

When creating or updating the Active Dossier from Submissions Archive, Vault:

  • Retrieves any active Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship records to create corresponding Active Dossier Structure records based on the Active Dossier Template
  • Determines the ID and version of each document within the Submissions Archive dossier
  • Retrieves the source document for each Submissions Archive-type document based on the Source References relationship
  • Adds to the Active Dossier source documents whose metadata (Product, Product Variant, Manufacturer, Active Substance, Inactive Ingredient) match a Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship record.
    • For eCTD submissions, the XML fields on the Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship record must also match the XML metadata for the leaf in Submissions Archive.
    • Vault creates or updates the Active Dossier Item record using the metadata from the matching relationship record.
    • For documents with only Product Family defined, Vault creates records based on the match with the Application’s associated Product Families.
  • Populates or updates the Active Dossier Status field to Submitted, as well as setting the Document field with the Submissions Archive document, within any newly-created or updated Active Dossier Item and Active Dossier Item Detail records.
  • Updates Needs Submission to “No” (false) if set to “Yes” (true) on updated Active Dossier Item Detail records.

From a Submission Content Plan

When creating or updating the Active Dossier from a Submission Content Plan, Vault:

  • Retrieves any active Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship records to create corresponding Active Dossier Structure records based on the Active Dossier Template
  • Retrieves the source document based on the matched documents in each Content Plan Item in the Submission Content Plan. Matched documents must be version locked on the Content Plan Item to be considered.
    • Vault ignores items that are inactive or have a “Delete” XML Operation.
  • Creates or updates the Active Dossier Item record based on the metadata from the Submission Product, Submission Active Substance, or Submission Inactive Ingredient relationship record referenced on the Content Plan where the document is used.
    • For documents within Content Plan sections that do not have a Submission Product, Submission Active Substance, or Submission Inactive Ingredient defined, records are created or updated based on matching values between the document’s Product Family and the Application’s associated Product Families.
  • Populates or updates the Active Dossier Status field to Submitted, as well as setting the Content Plan and Content Plan Item fields, within any newly-created or updated Active Dossier Item and Active Dossier Item Detail records.
  • Updates Needs Submission to “No” (false) if set to “Yes” (true) on updated Active Dossier Item Detail records.

About Translation Documents

In countries where submissions are provided to the Health Authority in the local language, Vault identifies the translation source document for inclusion within the Active Dossier. Vault includes the document in the English language as the Active Dossier Item record, and captures the non-English language document as an Active Dossier Item Detail record that you can reference.

If the Language document field is populated with a value that is not English, Vault uses the Translation document relationship type to retrieve the English language source document. Vault creates Active Dossier Item and Active Dossier Item Detail records for each source document in the Translation document relationship of the non-English document.

Configuring the Update Active Dossier Entry Action

The Update Active Dossier entry action is configurable within a Regulatory Objective lifecycle state. Two configuration options are available when the Update Active Dossier system action is configured.

Decision/Status

The Decision/Status picklist has the following options:

  • Current
  • Rejected
  • No Decision
  • Withdrawn

When Current is configured on the entry action:

  • For each document included in the submission’s archive or relevant content plan with an operation that is not Delete, Vault sets the Active Dossier Status to Pending Current.
    • If Vault finds that there is already an Active Dossier Item Detail with a Current or Pending Current status that has a later version in the document version tree than the document included in the Submission’s Archive or Content Plan, the status for the Active Dossier Item Detail record is cleared instead of changed to Pending Current. The status of the record for the later version in the document version tree is unchanged.
  • Vault attempts to determine superseded document versions to set the Active Dossier Status to Pending Superseded or blank for prior document version Active Dossier Item Detail records that meet the following conditions:
    • Set with the relevant Application that the calculation occurs in
    • Metadata matches any of the related Regulatory Objective’s relationships

    • Active Dossier Status of Current or Pending Current

      • If the Active Dossier Item Detail record has a status of Pending Current, Vault clears the status.
    • Is seen as a previous document version either via version tree calculation or using the Originates From document relationship:
      • Version tree calculation: Document with the same document ID and an earlier version within the document version tree than the version that is being set to Pending Current. For example, if a document with ID of 1234 and version of 5.0 is calculated as Pending Current, an Active Dossier Item Detail with ID of 1234 and version of 3.0, Active Dossier Status of Current, and that meets the above conditions is set to Pending Superseded.
  • Originates From document relationship: Document that is a direct or indirect target of the Originates From document relationship by the document that is being set to Pending Current. For example, document F is set in the Originates From document relationship of document G, and document G is set in the Originates From document relationship of document H. An Active Dossier Item Detail record for document H will be set to Pending Current. An existing Active Dossier Item Detail record for document F with a Current status that meets the above conditions is set to Pending Superseded.

When Rejected is configured on the entry action:

  • Active Dossier Item Details for all Submissions associated with the Regulatory Objective where the entry action is initiated are moved to the Rejected Active Dossier Status.

When No Decision is configured on the entry action:

  • Active Dossier Item Details for all Submissions associated with the Regulatory Objective are moved to the No Decision Active Dossier Status.

When Withdrawn is configured on the entry action:

  • Active Dossier Item Details for all Submissions associated with the Regulatory Objective where the entry action is initiated are moved to the Withdrawn Active Dossier Status

Approval Type

When the Decision/Status is set to Current, the Approval Type is available for configuration. The Approval Type picklist has the following options:

  • Explicit Approval
  • Implicit Approval
  • Partial Approval

The Approval Type configuration is only available if the Decision/Status is set to Current.

  • When Explicit Approval is configured, the Approval Type field is set to Explicit Approval on the relevant records related to the Regulatory Objective.
  • When Implicit Approval is configured, the Approval Type field is set to Implicit Approval on the relevant records related to the Regulatory Objective.
  • When Implicit Approval is configured, the Approval Type field is set to Implicit Approval on the relevant records related to the Regulatory Objective.

eCTD Submissions

  • For eCTD submissions with a Leaf Operation of Replace, Vault locates the target document of the Replace operation and sets the status of the Active Dossier Item Detail record for that document as Pending Superseded as long as the target document’s Active Dossier Item Detail record has a status of Current, the same Submission Metadata, and the same Application. If the target document’s Active Dossier Item Detail record has a status of Pending Current, Vault clears the status.
  • For eCTD submissions with a Leaf Operation of Delete, Vault locates the target document of the Delete operation and sets the status of the Active Dossier Item Detail record for that document as Pending Deprecation as long as the target document’s Active Dossier Item Detail record has a status of Current, the same Country, and the same Application. If the target document’s Active Dossier Item Detail record has a status of Pending Current, Vault clears the status.