The customizable bioinformatics system designed to accelerate your research
BRICS, an enterprise solution, is a collaborative and extensible web-based system to support the collection of research studies and clinical trials, using a set of modular components that cover all stages of the research life cycle. Importantly it's also a comprehensive integrated, end-to-end platform for clinical trial management, which allow investigators to design, conduct and manage studies easily and securely. And because BRICS is un-branded and un-associated with a particular disease or organization, it can be customized to meet your research objectives. This web-based application is 21 CRF Part 11 compliant, secure, and intuitive to use. In addition, users with programming expertise can use an application programming interface (API) for more dynamic data analysis including Artificial Intelligence and Machine Learning (AI/ML) applications. BRICS is actively used across the NIH and by the DoD for data warehousing, and clinical trials research.
BRICS: The Software - Plug and play components for the entire research life cycle
BRICS offers researchers a secure platform and a suite of tools to promote standardization, communication, and collaboration across the research community and a data repository to hold genetic, phenotypic, clinical, and medical imaging data. These plug-and-play modules can be shared across disease categories or deployed and branded independently, depending on the needs of your program. Together, they provide a combination of web-based functionality and downloadable tools that support data definition, data contribution, and data access throughout the research life cycle.
Account Management
This is the application for creating, approving, and managing user accounts, including management of access controls, roles, permissions groups, and authorization to other BRICS modules. The traditional username/password Log in flow for BRICS has been replaced by NIH's Researcher Auth Service (RAS). This change will require all users to follow a set of steps to Log in/sign up for RAS and link your BRICS account to your RAS account. RAS supports 3 identity providers, a NIH PIV/CAC card, an account with Login.gov, or an ID.me account. If you have a NIH PIV/CAC card please use it, otherwise, please use Login.gov or ID.me.
Clinical Trials Management System (CTMS)
The Clinical Trials Management System (CTMS) provides critical support for the planning, and execution of clinical trials, provides reporting functions and management of important study documentation, correspondence, compliance and milestones. The CTMS provides users with a centralized location that is accessible for the storing and retrieval of study documents, with versioning. The CTMS tool integrates with the NIH PROTRAK system and is able to import, IRB documentation, milestones, dates and many other critical study information seamlessly.
Data Dictionary: Data Elements, eFORMS, Form Structures
The BRICS data dictionary is a well-designed and intelligent tool, created in close collaboration with key projects and organizations such as the NINDS CDE project, NIH CDE repository, CDISC, LOINC, FHIR, UMLS , and other controlled vocabularies/terminologies. It is equipped with terminology and services that ensure compliance with various vocabulary standards, enabling the seamless exchange of clinical research data in diverse formats across systems and sources.
Data Mapping And Transformation (DMT) Tool
The Data Mapping and Transformation (DMT) tool is an application used to translate data from users’ systems, that may not have consistently used BRICS CDEs, to CDEs used in the BRICS system. In addition, the system translation tool saves the translated data into a BRICS compliant CSV that can then processed by the Validation tool.
Data Repository: Study Management, Data Validation And Submission
The Data Repository is the central hub of the BRICS system, providing functionality for defining and managing study information, and for contributing, uploading, and storing the research data associated with each study. In the pursuit of making information discoverable for the research communities that the BRICS system serves, the following attributes have been incorporated into the Data Repository. ORCID identifier (ORCID iD) is a unique, personal, persistent identifier for researchers that distinguishes them from every other researcher. The BRICS system allows a researcher to include their ORCID iD. The Office of Science and Technical Information (OSTI) maintains a ** DOI ** minting service called the "DOE Data ID Service." Each BRICS study, using the OSTI DOI minting service (DataCite) can create a unique DOI. In addition, the BRICS system has implemented the Data Tag Suite (DATS) model to support the DataMed data discovery index with the goal to be for data what PubMed has been for the scientific literature.
Forum
Forum is a discussion board for account users for posting messages, interacting with each other, and discussing various topics. It is organized into categories or topics, with each thread containing posts and replies from multiple users. It is moderated by operations team members to ensure that the posts and comments have appropriate content. This is currently enabled on FITBIR (on both Portal and Public Sites), cdRNS (on both Portal and Public Sites) and NEI (only on Portal).
GUID: Global Unique Identifier - A Privacy Preserving Record Linkage System
The GUID is a Global Unique Identifier for each study participant that allows researchers to aggregate and share a participant’s data without exposing personally identifiable information (PII). The GUID is made up of random alpha-numeric characters and is not generated from PII/PHI.[1]
[1] Johnson SB, Whitney G, McAuliffe M, Wang H, McCreedy E, Leon Rozenblit L, Evans CC. Using Global Unique Identifiers to Link Autism Collections. J. Am. Med. Inform. Assoc., Vol. 17, No. 6, 689-695, 2010. PMCID: PMC3000750.
*Note: Since the time of publication, the term GUID has taken on a more general meaning – “An implementation of the universally unique ID”. In the context of the BRICS system, the GUID process could now be better identified as a Privacy Preserving Record Linkage (PPRL) system. However, since the BRICS GUID system has been using the GUID term in documentation and software for more than a decade and it is familiar to our community, we will continue to use it for now.
Imaging Tools: MIPAV Imaging Data Submission Tool
The MIPAV (Medical Image Processing, Analysis, and Visualization) application enables quantitative analysis and viewing of medical images, such as PET, MRI, CT, or microscopy. A MIPAV plugin is used to package and submit image data of many formats (i.e. DICOM, NIFTI, BIDS, Analyze, AFNI and many others) into BRICS.
"Focusing on open source components, MIPAV is the best candidate for 3D imaging as well as DICOM communication" (http://link.springer.com/article/10.1007%2Fs10278-015-9833-1)
For more information on MIPAV, visit https://mipav.cit.nih.gov/
Investigator Education and Training (InET)
Research often requires the management and tracking of personnel trainings, licenses, and related documentation (i.e. CVs, on boarding, roles, position, credentials, etc.). Some items such as trainings and licenses have predefined validity periods and need to be updated. In addition, the process of onboarding new personnel, or offboarding existing personnel often involves documentation and the coordinated effort across the study team, PI and other groups such as study monitor etc. The goal of InET Is to provide an effective solution for the management of the various required study personnel trainings and documentation in a central location that is accessible. In addition, InET is able to generate lists of specific trainings based on role (Physicial vs Post bac) or function (clinical research with patient contact vs sample management), and InET is able to track document versions and notify users of pending items or expiring trainings or documents. InET helps to ensure that users are continuously in compliance with research and clinical trials.
Datastore
The BRICS Datastore module is a flexible data store allowing for management and storage of primary and secondary data from research studies. Each Datastore is assigned a unique persistent identifier (a digital object identifier (DOI)) to support data discovery and provides controlled access (permission based) to datasets and metadata which coexist within the module. With the new NIH Data Management and Sharing Policy coming into effect January 25, 2023, utilization of the BRICS Datastore module aligns with NIH’s mandate to use a quality data repository that improves the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data.
ProFoRMS: Protocol Management And Data Capture
The ProFoRMS tool serves as the main module for electronic data capture, subject management, and scheduling. ProFoRMS’s electronic case reports forms (eCRFs) support both standard and custom eforms using the CDE library. In addition, this module includes support for the PROMIS API, empowering access to a state-of-the-art assessment system for self-reported & adaptive measures, which seamlessly integrate into the BRICS common semantic model.
Query And Export Data
The Query Tool provides access to harmonized data submitted by researchers. The efficiency of the application sifts through data by filtering on data elements and form structures. Moreover, Boolean operators (AND, NOT, OR), specificity (inclusive and exclusive), and joins across multiple form structures provide additional data exploration. The Query Tool API is an extension of the capabilities of this powerful tool which allows users to access data (JSON or CSV format) using their preferred IDE, such a Jupyter notebooks, and programming languages such as R and Python. The API allows researchers/data scientist to write Python code, incorporating Python’s extensive AI/ML libraries/ecosystem to provide AI/ML data analysis. Importantly, since the BRICS data dictionary/CDEs are a foundational aspect of BRICS, the CDEs provide accurate and rich metadata for each data point furthering the programmatic AI/ML analysis on both on-premise and cloud instances of BRICS.
STAMS: Specimen Tracking And Management System
STAMS is a comprehensive application for the tracking and management of samples that provides the ability to record complete sample information, including sample history and can be easily adapted to support a number of different sample types. STAMS pro vides the options for physical freezer and container inventory management and storage organization, and can be customized to match the physical dimensions of the freezer, tray and storage box. The integration with commercial barcode scanners and barcode printers facilities efficiencies with biosample collection, storage, management and retrieval. STAMS also has an intergrated brain pathology tool that is specifically designed for the management of brain repositories to include the ability for clinical recording of stains, brain slice annotation, next of kin interviews and the generation of pathologist reports. STAMS is integrated with the NIH medical records system via BTRIS and is able to ingest and display patient medical record information, and also has active support for ICD diagnosis codes.
