The Vault RIM family of applications is a comprehensive, cloud-based platform used to manage product and registration information, submission documents, and published dossiers. Vault RIM provides a seamless and integrated approach to regulatory information management. RIM applications can be used alone or together within a single Vault.
- Registrations is an end-to-end application for planning, tracking, and reporting of product and registration information, management of Health Authority interactions, and generation of IDMP messages.
- Submissions helps users 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.
- Submissions Archive is designed to import, archive, and view published submissions that were previously submitted to Health Authorities. Regulatory Affairs users can easily import submissions into Vault, where those submissions are accessible by any user, anywhere across the globe. An integrated eCTD Viewer allows for quick review of content in each application and its submissions, as well as providing information on what other applications’ or submissions’ content was used.
- Submissions Publishing provides an end-to-end publishing process to manage content planning, publishing, and finalizing submissions content in preparation for submitting to Health Authorities.
Brexit Impact
The United Kingdom (UK) formally withdrew from the European Union (EU) on January 31, 2020. The transition period began on February 1, 2020 and will end on December 31, 2020. As of January 1, 2021, Great Britain will be considered a third country to the EU. See Brexit Impact in RIM Vaults for more information, including some actions customers can take in their Vaults to continue licensing or to license new products in either the UK or the EU.
Data Model
RIM applications share a common data model, which allows you to consolidate data for all of these applications in one Vault. All objects appear in all RIM Vaults, but some will be unused if your Vault does not include all applications. Your organization can generate a Vault Configuration Report to see all objects in your Vault.
“Supporting objects” contain data that is mostly static or provided by health authority sources. Typically, users will not create records for these objects on a day-to-day basis, but the data contained in these records is critical for defining the context of other records in the system.
Key Shared Objects
This is not a complete list of shared RIM objects but provides some explanation of some important objects in the data model.
- The Application object contains all information regarding a request made to a Health Authority for approval to market a product or to conduct a trial in a particular country or region that falls under that Health Authority’s jurisdiction.
- The Submission object, child of Application, contains information about documents that are submitted to Health Authorities as part of an application. Information stored on this object includes: submission type and subtype, various dates that are applicable to the documents in the submission, and tracking numbers.
- The Product Family (
product__v)* object describes the product family at the highest level, combining its aliases, indications, studies that were done on it, substances that constitute it, and more. - The Product (
drug_product__v)* object describes the product formulation, specifically dosage form. Complex drug products may be modeled as a combination of multiple simple drug products. - The Product Variant (
product_detail__v)* object, child of Product, describes the different form strengths of a drug product. - The Controlled Vocabulary object contains a variety of controlled lists of values (supplied by Health Authorities and other public entities) that are used throughout the RIM family of applications. Examples include dosage forms, XEVMPD authorization status, application types, submission types, and routes of administration.
- The Regulatory Objective object allows users to group submissions that all support the same objective, regulatory activity, or change.
- The Commitment object allows your organization to store any commitments made to Health Authorities, including dates, related submissions, and links to any correspondence documents that pertain to the commitment.
Registrations Objects
The Registrations application uses the following objects in addition to those listed above. These appear in all RIM Vaults but are only used in Vaults that include Registrations.
- The Registration object contains all information regarding the approval to market a product in a particular country or region, specifically product, application, submission, registration authorization holder, impacted markets, and multiple dates indicating the status of the registration.
- The Event object holds information about Regulatory Events that may have an impact on a product’s registration status and approval to be sold in certain markets. There are several types of these, such as Manufacturing Events, Labeling Events, Safety Events, etc.
- The Activity object is a child of the Event object, and its records house the individual country (or affiliate) action with respect to the parent event. While an event in one market might trigger a submission based on the Health Authority’s regulations for that market, the same event in another market may not require any action.
- The Medicinal Product object represents the product as it is sold in a specific market. The medicinal product is ultimately what is registered for sale (as recorded in the Registration object) in a particular market.
- The Packaging object contains any information pertinent to packaging details of the product.
There are numerous other objects that make up the Registrations data model. These are all available for use and configuration within your Vault. In order to accurately maintain the real-world relationships between these data elements, the data model includes several many-to-many and parent-child relationships linking objects together.
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*In Vaults created after the 19R1 release, the following objects are relabeled to support medical devices:
In existing Vaults, Admins can update these objects manually. |