FAQ

The National Trauma Research Repository (NTRR) is a collaborative effort involving the Coalition for National Trauma Research (CNTR), National Institutes of Health (NIH), and the US Army Medical Research and Development Command (USAMRDC) to develop a data repository for trauma research. This is a Department of Defense-sponsored cloud-based data repository for clinical trauma research data that supports national trauma research efforts. Investigators are encouraged to upload their data resulting from trauma research. Users access the NTRR through the same platform that supports the Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR). The system allows researchers to share their clinical research data sets and to access other study data sets for secondary analyses.

The NTRR will be a key piece of the national research infrastructure being developed to support the trauma research environment. It will eventually be a vast repository offering thousands of data points from hundreds of studies, which investigators can query for their own research. A robust research infrastructure will support trauma investigators in competing for federal research dollars.

The purpose of the NTRR is to advance trauma-related research by providing the infrastructure that enables investigators to access and use clinical research data that has not previously been available. Like other research data repositories, the NTRR will:

•     Facilitate the publication of new research using existing data, expanding the return on investments made in clinical trials
•     Enable replication of findings through secondary analyses of pooled data files
•     Optimize research participant contributions and data

The creation of a national repository for trauma clinical research data that makes data available for continuing use is a cost-effective solution to the lingering challenge of funding trauma research. 

Data stored in a fully developed and robust NTRR will cover the entire continuum of care, including injury prevention, point of injury, en route care, all phases of hospital care, and finally, rehabilitation/outcomes. This will be the central repository for clinical data resulting from both military and civilian federally funded trauma research. Data from research funded privately is also accepted. A means to upload Waveform and other imaging data will be developed soon.

The National Trauma Data Bank® (NTDB) is the largest aggregation of trauma registry data ever assembled. The goal of the NTDB is to inform the medical community, the public, and decision makers about a wide variety of issues that characterize the current state of care for injured persons. The difference between the NTRR and the NTDB is that NTDB data can be USED for research, but the data were not collected in the course of a research study. There are many additional variables collected by researchers conducting a study that are not included in the medical records typically uploaded into the NTDB. The NTRR will include all the additional variables that were collected in the course of research studies. Additionally, the NTRR will include multidisciplinary research studies that include orthopedics, neurotrauma, pediatrics, geriatrics, burns, and others.

Hospital trauma registries include de-identified information from medical records along with additional trauma information. Hospital registries do not include any additional data that is collected for a research study. The NTRR will include scrubbed, high-fidelity data with well-identified elements, uploaded from completed clinical trials.

The authors of the NASEM Report on a National Trauma Care System issued 11 recommendations including establishment of a National Trauma Research Action Plan (NTRAP) and creation of a data collection system for real-time data entry, validation, and analyses of multi-site studies—which the NTRR achieves. Once the infrastructure exists to support investigators in their work, the priorities identified in the NTRAP may be much more achievable, and the ultimate goal—zero preventable deaths—reachable.

To access CNTR’s National Trauma Research Action Plan (NTRAP) visit: https://bit.ly/NTRAPWebsite

Most federal funding sources require data sharing for funded research (e.g., NIH, DoD, NSF). Additionally, in a 2017 American Medical Association Journal editorial, the International Committee of Medical Journal Editors (ICMJE) argued that “there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.” Committed to this idea, the ICMJE now requires that manuscripts submitted to ICMJE journals reporting results of clinical trials must contain a data sharing statement; and that clinical trials enrolling participants on or after January 1, 2019 must include a data sharing plan in their registration. 

Investigators receive scholarly credit for sharing their data through the linkage to the original study’s Digital Object Identifier (DOI); they may also discover collaborations with new investigations. 

Access to the data housed in the National Trauma Research Repository is controlled through an application process. Access to data for research purposes is provided through the NTRR Data Access Subcommittee. Membership of this committee includes researchers and staff with expertise in the relevant scientific disciplines, research participant protection, and privacy. The NTRR Data Access Subcommittee reviews data access applications (which include an Investigator Information Form, a current biographical data sketch, institutional review board approval, a Data Access Request [see below] and a signed Data Use Certification) and makes a determination based on research institution affiliation and the scientific merit of the request. Investigators and institutions seeking data from the NTRR are expected to meet data security measures (such as physical security, information technology security, and user training). 

• Policies and Procedures: https://ntrr.nih.gov/policies-and-procedures

• Use the data only for the approved research; if the Recipient Investigator wants to use the data to investigate additional research questions, a second data access request form must be submitted
• Protect data confidentiality
• Follow appropriate data security protections
• Follow all applicable laws, regulations and local institutional policies and procedures for handling NTRR data
• Make no attempt to identify individual participants from whom data within a dataset were obtained 
• Make no attempt to sell any of the data elements from datasets obtained from the NTRR  
• Make no attempt to share with individuals, other than those listed in the request, any of the data elements from datasets obtained from the NTRR 
• Agree to the list of approved research uses
• Provide IRB approval memorandum and continuing reviews (if appropriate)
• Agree to report, in real time, violations of the NTRR Data Sharing Policy to the NTRR Executive Committee
• Adhere to the NTRR Data Sharing Policy with regard to publication; and Provide annual progress reports on research using NTRR data. 

The NTRR runs on the BRICS system and is compatible with FITBIR, which runs on the BRICS system. The BRICS system is Federal Information Security Management Act (FISMA) moderate compliant and implements the appropriate National Institute of Standards and Technology (NIST) security controls (NIST 800-53) and is certified for Title 21 CFR Part 11 of the Code of Federal Regulations .

NTRR as a BRICS derived system, inherits all of BRICS security and certification controls.

Yes, all data requests will be accompanied by an institutional review board approval memo for the study described in the Data Access Request. The qualifications of the requesting researcher are evaluated as described above. The Data Access Certification addresses the limited use of the data for the specific study and best security practices the investigators are expected to follow. The contributed data sets will not contain potentially identifiable data. The contributing investigators will affirm this when they submit data to NTRR.

All trauma-related applications for NIH/DOD funding are strongly encouraged to share their data with NTRR (see solicitation for specific details). Applications should include a description of the principal investigator's intent to submit data to NTRR, the type of data to be submitted, and the anticipated timeline for submissions. Clinical researchers are strongly encouraged to use the NTRR Core CDEs, in addition to the Basic CDEs that correspond to the therapeutic area as defined. To support the costs associated with data submission, include the FITBIR Cost Model into the budget of your application.

• NTRR Submission Costs
• Project Estimation Tool

The 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). GUIDs are random alphanumeric characters that are not generated directly from PII. This capability provides two primary benefits. First, it allows data about a research participant to be accumulated across projects over time, regardless of where and when that data was collected. Secondly, it enables a researcher to define a study population while supporting a research hypothesis, even if the data was not collected by the researcher. 

The Accounts Module is where users can manage their account details, such as renewing their accounts, updating their passwords, uploading documents, and requesting new module privileges.

The Protocol and Form Research Management System (ProFoRMS) module provides the tools for protocol management, data capture, and is a clinical trial/research module. Please review the ProFoRMSuser guide for additional information.

The NTRR Data Dictionary incorporates and extends the Common Data Element (CDE) definitions developed by the NINDS (National Institute of Neurological Disorders and Stroke) CDE Workgroup. The Data Dictionary also allows investigators to define the data they submit as well as provide alternate terms (aliasing) and translation rules for the same element. Occasionally, research data may not align perfectly to the Common Data Elements. In this case, researchers may extend the Data Dictionary and create unique data elements (UDEs) with permission from NTRR Program.

The Data Repository module 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.

The query tool provides the ability to aggregate and filter research data from studies located in the Data Repository.

The Meta Study module allows users to create a study that contains findings from other studies, which can be used by researchers to conduct additional analysis.

Information on the technical infrastructure is available in the System Design Document .

The BRICS Development Processes contains details for the development processes and has the following documents:  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.

NTRR is aware of the wide usage of REDCap among investigators and study teams. NTRR provides a REDCap Data Element report guide in the form of a CSV file that is in 80% alignment with the REDCap standard.  NTRR form structures allow for repeatable groups where one column can be used to collect data. For example, blood pressure taken at multiple time periods during an appointment could be recorded in NTRR using one column, whereas REDCap requires each point the blood pressure is taken to have a new column to record data. Further refinement and data cleanup of the CSV file is needed in order to upload correctly into the REDCap system.