The customizable bioinformatics system designed to accelerate your research.
BRICS 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.
A system for data sharing and collaboration.
Building on concepts originally developed for the National Database for Autism Research (NDAR), BRICS began as a joint effort between the Department of Defense (DOD), Department of Health and Human Services (HHS)/National Institutes of Health (NIH): National Institute of Neurological Disorders and Stroke (NINDS), and the Center for Information Technology (CIT). Since then, it has continued to evolve over a rich 10-year history, through collaborations with partners like the Parkinson’s Disease Biomarkers Program (PDBP) and the Federal Interagency Traumatic Brain Injury Research (FITBIR).
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:
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 will soon be 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 2 identity providers, a NIH PIV/CAC card, or an account with Login.gov. If you have a NIH PIV/CAC card please use it, otherwise, please use Login.gov.
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.
Data can be collected remotely using a patient self-report module (PSR), or offline using the Offline System for Trials and Research Information Collection and Housing (OSTRICH) app (compatible with iOS, Android and Windows), a BRICS application that facilitates offline data collection and ingestion into ProFoRMS once online connectivity is available. OSTRICH is currently available for iOS devices in the Apple App store and for Android devices in the Google Play store. Please go to the respective app store and search OSTRICH data collection. Please install the app. When the app first launches, please select the instance that the user will be using (i.e. Production or Demo). To change instance in the future, please remove OSTRICH and reinstall. For the Windows version of OSTRICH, please contact the support team. The system also offers electronic consenting capabilities and features to allow anonymous survey collection, if needed. Moreover, ProFoRMS includes important functionality including: question skip logic, auto calculations, reporting, data validation and more.
As part of the 21 CFR Part 11 compliance, ProFoRMS has complete audit trails for data collection and inbuilt data auditing capabilities. Subsequently, electronic records and electronic signatures within BRICS are considered trustworthy, reliable, and equivalent to paper records.
The 21 CFR Part 11 system documentation contains the following documents: System Design Document, E-Signature Security Policy, Master Test Plan, Report on 21 CFR Part 11 Compliance, Software Development Process, System Requirements Specification, System Access Logs and User Guidelines. ProFoRMS also has the capability to integrate with EHR system databases.
At the NIH, this system is integrated with BTRIS and researches are able to obtain clinical data, seamlessly. In addition, FHIR connectivity is supported.
a. System has digitized versions of common protocol logs (monitoring visits, delegation of authority, screening – enrollment, subject identification, training, deviations, UADE, UP)
b. E-binder is available with audit trail
c. System can support multi-site clinical trials and research protocols
d. There is full role-based control for access to the system’s features
e. Raw data export can be filtered and accessed in real-time – helpful for DSMB reporting.
f. Anonymous survey capabilities – remote data collection
g. Ability to perform randomization of subjects, blind/unblind users, control randomization based on eligibility criteria
InET (*In*vestigator *E*xperience and *T*raining) - This is the application for assigning new training, tracking current training, licenses and compliance requirements for managing user credentials to ensure compliance with research and clinical trials conduct.
The Clinical Trials Management System (CTMS) is designed for the management of Clinical Trials. This module enables insight into trial performance (recruiting, compliance, adverse events), management of regulatory documents and FDA compliance requirements, tracking of protocol changes and other important milestones and required information.
Data Dictionary: Data Elements, eFORMS, Form Structures
A well-designed, intelligent clinical research data dictionary created in close collaboration with NINDS CDE project, NIH CDE repository, CDISC, LOINC, FHIR, UMLS and other controlled vocabularies/terminologies. Also supports:
- OMOP 6.0
- Conversion of CDEs to REDCap format
- Mapping tool from UMLS concepts to BRICS CDEs
BRICS data dictionary is equipped with terminology and services which enable any BRICS system to comply with diverse vocabulary standards and exchange of clinical research data, received in all of its various formats and terminologies from diverse systems and sources. When embedded into an informatics system infrastructure, BRICS dictionary helps promoting FAIR principles and allows to:
- Support standardization of clinical research data across various projects by incorporating standard controlled vocabularies;
- Describe clinical research data in a structured way and remove ambiguities;
- Enable users to effectively find, query, and report data;
- Support exchange and comparison of research data between independent informatics systems.
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.
The BRICS Meta Study module is a flexible data store allowing for management and storage of primary and secondary data from research studies. Each Meta Study 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 Meta Study 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.
The two main use cases for the BRICS Meta Study module are as follows:
- Meta Analyses
- Facilitates aggregation of data from other studies within the BRICS Repository module for meta analyses
- Facilitates aggregation of data from other studies within the BRICS Repository plus accommodates upload(s) of data external to BRICS to be included in meta analyses
- Data Store/Repository
- Facilitates storage of data from studies that do not have requirements to upload data to the BRICS Repository module
- Supports NIH Data Management and Sharing Policy
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.
*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.
The National Institute of Neurological Disorders & Stroke (NINDS), in conjunction with the National Institute of Aging (NIA) and the National Center for Advancing Translational Sciences, and the Common Data Repository for Nursing Science (cdRNS) and Parkinson’s Disease Biomarkers Program (PDBP), have successfully collaborated to develop a Multi-Tenant ‘Global Unique Identifier’ (GUID) solution for participant sharing across institutes and studies, known as the NINDS Centralized GUID solution.
1. Management of study participants through the generation of a secure, random alphanumeric identifier (GUID)
2. Mapping of study participants to study data for more efficient/comprehensive analysis
3. Visibility to matching study participants/GUIDs across institutes and studies
4. Collaboration amongst researchers to share study data (offline) about participants
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 foundationally 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.
BRICS 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 (https://bids.neuroimaging.io/), 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/
VolView in the BRICS Query Tool
BRICS integrates VolView (https://volview.kitware.com/) into the Query Tool for users to view high-quality, interactive cinematic volume renderings and tri-planar visualization of the image volumes returned by their queries into the data repository. VolView is an open source radiological viewer developed for clinical professionals, offering 2D and 3D controls, measures, and annotations.
STAMS is an 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 provides the path to container storage locations (e.g. freezer) that guides the user to the specific container and sample. STAMS supports custom containers of any shape (box, circular or Pie configuration) and size to meet the user’s specific requirements.
a. Any sample type (fluid, tissue etc.)
b. Bar codes can be printed from within the system (currently Zebra printers are supported)
c. Bar codes can be scanned directly into the system
d. Samples can be linked to subject information in ProFoRMS
e. Sample quantities and use can be tracked and monitored
f. Ability to retrieve subject data (imaging, clinical data, and samples) in a comprehensive manner.
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 will be 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).
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.