Vault RIM Submissions is an end-to-end application to manage the authoring, review, approval, and assembly of regulatory submissions content, such as clinical study reports, manufacturing information, nonclinical reports, summaries, and labeling. Vault Submissions also includes binder templates that allow assembly of content into defined submissions structures, such as the eCTD.
Vault Submissions includes pre-configured document types and fields based on the DIA EDM Reference Model standard. A complex data model allows organizations to store additional data about submissions and documents. The application also provides several review and approval workflows to use for documents stored in the Vault.
Submissions is part of the Vault RIM family of applications. Within a single Vault, your organization can have one, two, or all of these applications. These applications share a common data model, but each provides additional pieces of functionality to help manage Health Authority applications.
Vault Submissions is built on the Vault platform and includes the features described in the platform help topics. In addition, it includes these capabilities and configurations specific to managing documents for medical information inquiries:
- Document Types: To facilitate quick on-boarding for new customers, new Vaults include a variety of default document types, subtypes, and classifications. The default document types are aligned with the required content for regulatory submissions, i.e., Clinical, Nonclinical, Quality, Regulatory, Pharmacovigilance and Literature.
- Lifecycles & Workflows: Vault Submissions includes lifecycles and associated workflows to facilitate authoring, review, and approval of content and of submission binders.
- Advanced Data Model: To allow content sharing globally or locally for a specific market, and to provide rich metadata on each document, Vault Submissions provides objects that store pertinent information and support reuse and searching of that data across multiple products and documents.
- Country- & Market-Specific Actions: To allow for different review and approval processes globally, Vault Submissions supports configurable document lifecycle and workflow actions based on a variety of document fields, including country.
- Content Planning: With submission content planning, customers can move away from spreadsheets and quickly create a list of all documents they expect to collect as part of a submission in Vault. The Content Plan object tracks all submission-specific information about each document.
- Active Dossier Viewer & Editor: The Active Dossier Viewer lets sponsors see a document’s status across multiple markets, while the Active Dossier Editor helps sponsors maintain a list of current documents for a given product and market.
- Report Level Content Plans & Publishing: The Report Level Content Plan object lets customers compile and publish reports outside of a submission, such as Clinical Study Reports, Nonclinical Study Reports, Periodic Safety Reports, and Investigator’s Brochures.
- Dynamic Linking: When publishing report level content plans, customers can create cross-document permalinks within the source document that target bookmarks and destinations within Vault. In Microsoft Word™ documents, links that you create can persist even as content changes during the authoring process. During publishing, Vault converts these links to standard relative PDF links.
- Publishing Status Indicator: A status icon informs users if there are outstanding publishing or validation jobs. This ensures that users only review and submit content after it has been published and validated.
- CRF and Dataset Import: Users can quickly and easily file all final subject CRFs and datasets into Vault. Vault automatically assigns the imported documents to the correct study/site and sets them to Approved status and major version 1.0.
- SPL Rendition: Vault can create PDF viewable renditions from uploaded SPL submission ZIP files.
- 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.
The daily Delete Inactive Content Plans job deletes unused, inactive Content Plan and Content Plan Item records, reducing the number of unnecessary records which can cause performance issues in some Vaults. This is especially relevant in Vaults where users prefer to assemble a content plan by starting with inactive records, then activating select records as needed.
Each time the job runs, Vault deletes up to 50,000 records that meet the following criteria:
- Status is Inactive
- The Content Plan Item’s All Document Count (
all_doc_count__v) equals zero (0) or is blank
- For submission content plans, the Submission record’s Actual Submission Date (
actual_submission_date__rim) is at least 365 days earlier than the current date
- For report level content plans, the Last Published Date (
last_published_date__v) is at least 365 days earlier than the current date
- For global content plans, the Event Complete Date (
event_complete_date__v) is at least 365 days earlier than the current date
Vault logs the deleted record details in a CSV file you can download from the Job Status page.
Activating the Job
The Delete Inactive Content Plans job is inactive in RIM Submissions Vaults by default. To schedule it, set the Job Definition Status to Active.
We recommend Admins activate the job in most Vaults. However, the job can remain inactive in Vaults where automatic record deletion is deemed to interfere with any custom processes, configurations, or integrations.
Configuring & Using the Cleanup Status Field
The Delete Inactive Content Plans job uses the Cleanup Status picklist field to determine which records are eligible for deletion.
To view a record’s Cleanup Status, you can add it as a column in the Content Plan Hierarchy Viewer. Optionally, you can also add the field to the page layouts of the following Content Plan object types:
- Report Level Plan Clinical Study
- Report Level Plan Nonclinical Study
- Root Content Plan
As the job runs, Vault references the Root Content Plan’s Cleanup Status field to determine whether to process the content plan records within the Root in the operation:
- When the Root Content Plan record has a status that is blank or In Progress, the records within the content plan are eligible for deletion when the deletion criteria is met.
- When the root record has Skip or Error status, the job does not process the records within the content plan.
- When only some of the inactive records have been cleaned up within a root record, Vault sets the status to In Progress. This is most likely to occur when the job reaches the limit of records it can delete during the current run.
- When Vault encounters an error deleting records within a root record, it sets the field to Error.
- When Vault successfully deletes all of the valid inactive records within a root record, it sets the field to Success.
All details are captured in the job log, which you can use to locate and review the Error status records. Once you’ve resolved the error, you can clear the field on the Root Content Plan record to allow Vault to assess it again during the next job run. Similarly, you can manually set the field to Skip to prevent the job from processing the records within the Root Content Plan during the next job run.
Validation Results Archival
The daily Validation Results Archival job allows users to reference validation results without cluttering their Vaults with unnecessary records. The job:
- Creates an archive package ZIP file for a Report Level Content Plan’s validation results 365 days after the Last Published Date
- Adds the archive package as an attachment on the Report Level Content Plan record
- Deletes the archived Submission Validation Results records
RIM to Clinical Operations Vault Connection
This connection between a RIM Submissions Vault and a Clinical Operations eTMF Vault automates data sharing between the two applications, supporting automatic transfer of Product, Study, and Site data and documents. See details about the RIM to Clinical Operations Vault Connection.
RIM to PromoMats Vault Connection
This connection between a PromoMats vault and a RIM Submissions vault automates compliance package generation and submission to the FDA through the gateway. See details about the RIM to PromoMats Vault Connection.
- Configuring Submission Content Plans
- Using Submission Content Planning
- Configuring Report Level Content Plans
- Configuring Report Level Publishing
- Using Report Level Content Plans
- Using Dynamic Linking
- Viewing Publishing Progress
- Using the Content Plan Hierarchy Viewer
- Configuring Constraints
- Content Plan Filtering
- Create a Document from Template for Content Plan Items
- About SPL & XML Renditions
- Configuring Cascading Review & Approval for Binder Content
- Managing Content Plans with a Lifecycle
- Creating Content Plan Templates
- Configuring a Workflow for Matched Documents
- Copying Into Content Plans
- Using Keyboard Shortcuts in the Hierarchy Viewer
- Starting a Workflow in the Content Plan Hierarchy Viewer
- Using Saved Views
- About the Progress Icon Field
- Configuring Cascading State Changes for Content Plans
- Configuring the RIM to Clinical Operations Vault Connection
- About the RIM to Clinical Operations Vault Connection
- Setting Up CRF & Dataset Import
- About the RIM & PromoMats Vault Connection
- Configuring the RIM & PromoMats Vault Connection
- Using CRF & Dataset Import
- Configuring Form 2253 Generation for Submissions
- Generating Form 2253
- About Active Dossiers
- Active Dossier Configuration
- Working with Active Dossiers