**Source URL:** https://regulatory.veevavault.help/en/lr/18967/

# Active Dossier Generation & Calculation Overview

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:

1. 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.  
2. 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.  
3. 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.