# 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. Vault supports country-level control over Active Dossier generation. You can exclude specific countries from automated Active Dossier Item Detail (ADID) creation using the Exclude from Active Dossier Generation field on Application Country and Submission Country records. 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](/en/lr/71673/) 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](/en/lr/28082/), 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 Application's _Active Dossier Template_ field, the source documents and document types of matched documents from Submission Content Plans. During this process, Vault evaluates Submission Countries associated with the Submission. If _Exclude from Active Dossier Generation_ = Yes, Vault does not create ADIDs for that country. If No or blank, Vault includes the country in Active Dossier generation. 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. ### From a Global Content Plan Dispatch {#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. * Active Dossier Item Detail records are created only for submission countries that are not excluded from Active Dossier generation. If a submission country is marked as excluded, Vault skips ADID creation for that country. * For Applications where the _Enable Active Dossier Generation_ (`enable_active_dossier_generation__v`) field is set to No, Active Dossier records are not created. * 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][1] using the document version tree to set _Active Dossier Item Details_ for older versions to _Pending Superseded_ (if _Current_) or _Replaced_ (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 set to _Replaced_ 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_. * Records are automatically generated when using cross-template dispatches if the **Populate Active Dossier** checkbox on the GCP dispatch is enabled. Active Dossier records are created even for documents that are unmapped or later rejected in the comparison. * The _End Date_ field is defaulted with the current date on Active Dossier Item Details (ADIDs) that are moved to Pending Superseded/Deprecated or blank status as part of the current calculation. * The _Dispatch Date_ is defaulted with the current date on ADIDs created from a GCP dispatch. * The [_Latest for Authoring_ and _Latest for Authoring End Date_][2] fields are updated upon creation of new Active Dossier Item Details from a Global Content Plan Dispatch. 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. * Active Dossier Item Detail records are created only for submission countries that are not excluded from Active Dossier generation. If a submission country is marked as excluded, Vault skips ADID creation for that country. * 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. * The [_Latest for Authoring_ and _Latest for Authoring End Date_][2] fields are updated upon creation of new Active Dossier Item Details. When the [Disable Archive Population Path](/en/lr/71560/#disabling-submissions-archive-path-from-active-dossier-generation) setting is configured, creating or updating the Active Dossier from Submissions Archive is disabled. ### 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. * Active Dossier Item Detail records are created only for submission countries that are not excluded from Active Dossier generation. If a submission country is marked as excluded, Vault skips ADID creation for that country. * 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. * The [_Latest for Authoring_ and _Latest for Authoring End Date_][2] fields are updated upon creation of new Active Dossier Item Details. * When the **Enable Active Dossier Global Tracking** checkbox is configured on the **Populate Active Dossier** system action, Vault updates existing global Active Dossier records created from Global Content Plan dispatch from ‘Dispatched’ to ‘Submitted’ when the same document version is submitted locally, ignoring if the document was submitted under the same content plan context. * To access the system action action to enable the checkbox, navigate to **Admin > Configuration > Workflows**, select the relevant Workflow (for example, "Generate AD records from Submissions"), then select the **Populate the Active Dossier** action. When the [Disable Archive Population Path](/en/lr/71560/#disabling-submissions-archive-path-from-active-dossier-generation) setting is configured, Vault sets the Archive document fields if the document was published based on the Archive document fields linked in the Content Plan Item ### For Registration & Product Information Tracking {#registration-and-product-information-tracking} When Active Dossier Registration Tracking is [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) in a Registrations Vault and the Active Dossier is populated from a Global Content Plan dispatch or Submission Content Plan, Vault automatically creates _Active Dossier Item Detail_ relationship records for _Registrations, Product Variants_, _Manufacturers_, and _Inactive Ingredients_ based on matching fields between related _Registrations_, _Active Dossier Item Details_, and document metadata per the below logic. First, Vault determines in-scope _Registrations_ according to a record's: * Lifecycle state, where the record must be in a state which maps to a [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) state type. * Referenced _Regulatory Objective_ (via the _Registration Regulatory Objective_ relationship), or its referenced _Application_. Vault uses the referenced _Application_ when the _Active Dossier Item Detail_ record: * Has a blank _Regulatory Objective_ field, or * The record does not have any _Registration Regulatory Objective_ relationships. * Referenced _Country_ which matches an _Active Dossier Item Detail_. Depending on your Vault's [configuration](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) and the procedure type, in-scope _Country_ records can be further filtered based on [Procedure Type Country _Constraints_](/en/lr/43081/#dynamic-procedure-countries). * Relationships, where the _Registration_ must be linked to at least one _Registered Product_ and/or _Registered Active Substance_ that is in a [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) state type and matches the _Product_ or _Active Substance_ on the _Active Dossier Item Detail_. Then, Vault creates the _Active Dossier Item Detail_ relationship records accordingly, depending on your configuration. * Registrations are tracked via _AD Item Detail Registration_ records. Vault creates these records according to the same logic it uses to determine the overall in-scope _Registration_ records. * Manufacturers are tracked via _AD Item Detail Manufacturer_ records. * Vault creates these records for each _Manufacturer_ populated on _Registered Product_, _Registered Active Substance_ or _Registered Inactive Substance_, and _Registration_ records in the [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) state type. Vault only considers records set with a _Manufacturing Site Role_ value that is not excluded from Active Dossier. * The above records must also match the values set on the _Active Dossier Item Detail_ record and the related document. A blank field or record where the _Special Record Classification_ field is set matches with any value. * Product Variants are tracked via _AD Item Detail Product Variant_ records. * Vault creates these records for each _Product Variant_ populated on _Registered Product_ and _Registration_ records in the [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) state type. * The above records must also match the values set on the _Active Dossier Item Detail_ record and the related document. A blank field or record where the _Special Record Classification_ field is set matches with any value. * Inactive Ingredients are tracked via _AD Item Detail Inactive Ingredient_ records. * Vault creates these records for each _Inactive Ingredient_ populated on _Registered Inactive Ingredient_ and _Registration_ records in the [configured](/en/lr/71560/#configuring-active-dossier-registration-and-product-information-tracking) state type. * The above records must also be referenced by the _Active Dossier Item Detail_ record and the related document. A blank field or record where the _Special Record Classification_ field is set matches with any value. ## 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 does not include 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. ## How Vault Sets Latest for Authoring Vault automatically sets Latest for Authoring (LFA) when a new Active Dossier Item Detail (ADID) is created from population processes, drag and drop, or Active Dossier Loader. When setting the _Latest for Authoring_ field, Vault pulls the ADIDs for any earlier and later versions of that document to determine whether the document version that the ADID is being created for is the latest version in its document hierarchy. This can be by: 1. The document version of the document (for example, v3.0 is later than v2.0 of the same document ID) 2. Using the Originates From document relationship. If a document B originates from document A, then document B is considered to be later than document A. If Vault finds an ADID for a later version of the document the new ADID is being created for, then the new ADID will be set with LFA \= No. If Vault does not find a later version, it sets the document's LFA to Yes. Vault looks at the ADIDs representing previous versions of the document version and sets the previous version that it finds that has LFA value of "Yes" to "No". For example, if an ADID is created for v3.0,Vault sets the ADID with v2.0 that was previously LFA \= Yes to LFA \= No. In this case, Vault also sets the *Latest for Authoring End Date* with the date that the value was changed from Yes to No. Vault calculates the LFA within the scope of the same Application-, Country-, and Product-related metadata. ## Special Handling for Published Report Level Content Plan Documents During Active Dossier generation, if the document is the published output from a Report Level Content Plan (_Published by RLCP_ field is set to _Yes_), Vault retrieves the source document(s) in the _Source References_ relationship of the published report document to generate the Active Dossier Item and Active Dossier Item Detail records. The _Published Report Document_ field is populated with the published RLCP document version. The Active Dossier records are created based on the source document’s document type and not the published report document’s document type. If there are multiple documents in the Published Report Document’s Source References relationship, Active Dossier records are created for each document version reference in the relationship. [1]: #how-vault-calculates-country-status [2]: #how-vault-sets-latest-for-authoring