When you populate Active Dossier, Vault creates Active Dossier Item records from documents associated with a Global Content Plan (GCP), Submission Content Plan (SCP), or Archive. During subsequent Active Dossier calculations, Vault reevaluates those records and updates their statuses based on the latest submission information.
Active Dossier Generation
Vault generates Active Dossier Items from documents associated with a Global Content Plan, Submission Content Plan, or Archive. Active Dossier Items generated from a Global Content Plan always include an Event.
Generating Active Dossier Items from Submission Content Plans
Vault adds documents from Submission Content Plans only when all of the following conditions are met:
- The document is matched and locked to a Content Plan Item (CPI).
- The Content Plan Item belongs to a parent Content Plan containing populated Submission relationship information, or for a document not matched to a Content Plan Item within a repeating section (for example, 3.2.S, 3.2.P, or 3.2.A), the document’s Product Family matches an Application Product Family.
- The document type is mapped in the Active Dossier Template or a valid RIM Reference Model used for Active Dossier.
Generating Active Dossier Items from Archive
Vault adds documents from the Archive only when all of the following conditions are met:
- The Archive document has a source document relationship.
- The source document’s document type is mapped in the Active Dossier Template or a valid RIM Reference Model used for Active Dossiers.
- Vault finds a matching Submission relationship record by comparing the metadata on the source document to the Submission’s relationships (for example, Submission Product or Submission Active Substance).
Vault compares metadata on the source document with Submission Product, Submission Active Substance, Submission Inactive Ingredient, Submission Clinical Study, Submission Nonclinical Study, or Submission Indication relationships. If a field is blank on the Submission relationship but populated in the source document metadata, then that is considered a match. The opposite is not the case: For example, when a field is blank on the source document metadata but populated on the submission relationship, then that is not considered a match. For eCTD submissions, Vault also compares the XML metadata stored in the Archive with the XML fields on the submission relationship. After identifying the matching Submission relationship, Vault populates Active Dossier Item metadata, such as Product, Active Substance, and Manufacturer.
Active Dossier Calculation
When the Active Dossier is calculated, Vault evaluates existing Active Dossier Item Details (ADIDs) and updates their statuses based on the latest submission information.
Vault collects the input ADID records for the calculation. Regardless of the submission’s dossier format (eCTD or non-eCTD), these are the records that meet the following criteria:
- ADID is set with a submission that is related to the Regulatory Objective (RO) that the calculation is triggered from or set with the RO that the calculation triggered from.
- ADID is set with metadata (product, active substance, manufacturer, inactive ingredient, clinical study, nonclinical study, indication) that is represented by a respective RO Product, RO Active Substance, RO Inactive Ingredient, RO Clinical Study, RO Nonclinical Study, or RO Indication relationship record.
- For ADIDs that only have Product Family populated, the Product Family must match a Product Family related to the RO’s Application.
Submitted Active Dossier Item Details are updated to Pending Current. Vault evaluates document version tree history or the document’s Originates From relationship to determine whether existing Pending Current items should become Pending Superseded.
Additional Calculation Logic when a Submission is eCTD
Calculation for Archive-generated Active Dossier Item Details
Vault uses XML operations to determine which Active Dossier Item Details should be marked Pending Superseded or Deprecated. Vault evaluates the Actual Submission Date to identify valid replacement targets. If the Actual Submission Date is blank, Vault uses the Import Date.
Calculation for Submission Content Plan-generated Active Dossier Item Details
Vault uses the XML Operation configured on the matched Content Plan Item to determine how Active Dossier Item Details are updated.
Veeva recommends configuring the default XML Operation on Content Plan Items as New. If the XML Operation field is blank, Vault does not update the Active Dossier Item to Pending Current.
If the XML Operation is Replace or Delete, Vault compares the XML Modified File value with the Submission Archive Leaf Tag ID to identify the appropriate Active Dossier Item Detail. This means the replacement target must be generated or updated from Archive.