Rehabilitation Dataset Directory: Repository Profile

Traumatic Brain Injury (TBI)

The Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System is a biomedical informatics system and data repository for Traumatic Brain Injury (TBI) research. It is a collaborative effort involving the NIH Institutes and Centers (ICs) and the US Army Medical Research and Development Command (USAMRDC). 

The FITBIR System is an informatics platform for TBI relevant data including medical imaging, clinical assessment, environmental and behavioral history, etc. and a wide variety of data types (text, numeric, image, time series, etc.). FITBIR has developed a data dictionary system allowing investigators to define additional TBI data elements and measures. The system was developed to share data across the entire TBI research field, facilitate collaboration between laboratories, and interconnectivity with other informatics platforms. The platform allows the sharing of data, methodologies, and associated tools, allowing re-analysis of data, as well as re-aggregation, integration, and comparison with other data, tools, and methods. It utilizes common data definitions and standards with comprehensive and coherent informatics approaches. 

Traumatic brain injury (TBI)

National Institutes of Health (NIH) and the

US Army Medical Research and Development Command (USAMRDC)

Clinical data, Survey, Phenotypic data, Imaging data, Genomic data, Behavioral data

Primarily North America

Primarily United States 

• Extensively documented
• Standardized definitions: the FITBIR data dictionary incorporates the Common Data Element (CDE) definitions developed by the NINDS (National Institute of Neurological Disorders and Stroke) CDE Workgroup. It also allows investigators to define the data they submit as well as provide alternate terms (aliasing) and translation rules for the same element. The data dictionary provides those who access the data with standardized clear and precise information about the available data.
• Data Validation tools at the submission stage help ensure data quality.
•  A wide variety of tools are available to enable researchers to identify data of interest (see Tools section below)
• FITBIR repository allows researchers to view details of each study that has been submitted. Data can be downloaded from each study exactly as it was uploaded.
• A Global Unique Identifier (GUID) allows participant data to be linked across different projects/studies. 

Some data designated as "private" and may not be available.

https://fitbir.nih.gov

List of repository studies:

https://fitbir.nih.gov/content/submitted-data

Data visualization:

https://fitbir.nih.gov/visualization

• Data Dictionary: Allows users to search for Common Data Elements (CDE), create and manage Unique Data Elements (UDE), browse, define, use and re-use electronic forms (eCRFs) and form structures across the studies.
• Data Mapping and Transformation (DMT) tool: supports data definition, data mapping, data transformation, and data access.
• Data Repository Tool: allows users to create, edit, manage, view and search for studies.
• Data Validation Tool: provides submission tools to assist  with the validation and upload of data into the repository and ensure data follows the required format and values as defined in the Data Dictionary. 
• Download Tool: for downloading selected datasets from the repository to your local machines, also available from the Query Tool.
• Global Unique Identifier (GUID): enables data to be associated with a research participant without exposing or transferring the research participant’s personally identifiable information (PII). The code generated allows linking of individual data between studies.
• Imaging Submission Tool : Streamlines image upload, download and validation to ensure formats and range values are appropriate.
• Meta Study module: Allows users to create and view findings from other studies in the system that have been aggregated by researchers to conduct additional analysis
• Protocol and Form Research Management System (ProFoRMS): A web-based data collection/research application based on NICHD’s Clinical Trail Database (CTDB). It includes modules to assist researchers to manage individual studies, subjects, eCRFs (electronic Case Report Forms), data collection, define electronic case report forms, schedule, and collect clinical data, and then export, analyze, and report on the data.
• Query Tool: Pulls the data from the repository and allows data filtering and manipulation based on the research question of interest. The data can be downloaded after applying the filters.

For more information on these tools see: https://fitbir.nih.gov/content/user-guides

All researchers submitting data must have a FITBIT account and complete a submission request form. Data submitted must follow all the validation criteria. The form is then reviewed by the Data Access Quality Committee.

See: https://fitbir.nih.gov/content/contribute-data

To assist in estimating the effort for a person responsible for submitting data to FITBIR (such as a data manager), a FITBIR Submission Cost Model is available. 

https://fitbir.nih.gov/jsp/contribute/fitbir-costs.jsp

Data access account required and is reviewed and approved by the Data Access Quality Committee.

Data access instructions:

https://fitbir.nih.gov/content/access-data

Data Use agreement, No cost 

Comprehensive user guides cover each of the following topics/tools:

https://fitbir.nih.gov/content/user-guides

• Data Dictionary
• Data Mapping
• Data Repository
• Data Validation
• Download Tool
• Global Unique Identifier (GUID)
• Imaging Submission Tool
•  Meta Study User Guide
• Protocol and Form Research Management System (ProFoRMS)
• Query Tool
  

Recent publications reusing FITBIR data:

https://fitbir.nih.gov/content/publications 

Common Data Elements and Federal Interagency Traumatic Brain Injury Research Informatics System for TBI Research

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4704986/

Progress in Developing Common Data Elements for Traumatic Brain Injury Research: Version Two – The End of the Beginning

https://www.liebertpub.com/doi/full/10.1089/neu.2013.2938