Central Repository for Clinical Trauma Research Data

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to issue a sole source award for United States Army Medical Research and Development Command’s (USAMRDC), Combat Casualty Care Research Program (CCCRP) program office for a new firm-fixed-price contract with the Coalition for National Trauma Research. The Government projects award for April 2023 using fiscal year 2022 Army funds with a funds ceiling is $1.8M. This sole source action is being authorized under the authority of FAR 6.302-5(a)(2)(i) Authorized or Required by Statute. Department of Defense (DoD) Appropriations Bill 117-88 2022, dated 15 July 2021 expressly states that award of the subject requirement be provided to (via Congressional Earmark) to Coalition for National Trauma Research (CNTR). Services include the USAMRDC CCCRP program office requiring a central repository for clinical trauma research data resulting from federally funded military and civilian trauma research. The central research

repository will be accessible via a user-friendly web-based interface application through which Government and civilian researchers will contribute and access clinical research data. Once the central repository is finalized all federally funded trauma investigators will be required to contribute data to it. The data in the central repository will be made widely accessible to the trauma research community. Repeated use of pooled data sets by that community to address new trauma research questions will decrease duplication of effort and improve efficiency and affordability of future federally funded clinical trauma research studies. The Coalition for National Trauma Research (CNTR) currently is the sole entity that possess the 64 studies of legacy data that will be used to further execute the central repository for clinical trauma research data resulting from federally funded military and civilian trauma research. Through a prior federally funded research cooperative agreement, W81XWH1520089, the CNTR (then known as the National Trauma Institute) developed and tested a scalable, limited capacity clinical trauma research data repository capable of generating pooled data sets which may be subjected to secondary analysis to answer new trauma research questions. Initial work completed by CNTR under W81XWH1520089 included establishment of a steering committee comprised of Department of Defense and civilian trauma researchers. The steering committee defined repository functional requirements and developed common data elements and data dictionary for clinical trauma research data. CNTR also initiated repository hardware and software requirements, and implemented the data management processes that allow data sets to be linked to their respective original studies. CNTR initiated data sharing policies and processes to protect the privacy of study subjects, minimize potential for misinterpretation or misuse of shared data, ensure contributing researchers are acknowledged in publications resulting from secondary analyses of shared data, and prohibit sharing of contributed data until the original contributing researchers have had opportunity to analyze the data themselves. CNTR’s resultant limited capacity trauma research repository was organized in four modules: prehospital care, inpatient care, rehabilitation, and long-term outcomes and quality of life. The repository is hosted in a secure cloud environment, and it conforms to Federal Information Security Management Act standards. Specific security controls in place for CNTR’s research repository include use of firewalls, secure sockets layer, application monitoring software and integrated cloud tools for operating system scanning and antivirus protection, password encryption technology, and security audits and inspections. The CNTR trauma research repository has 64 studies of legacy data and was built on the Biomedical Research Informatics Computing System (BRICS) at the National Institutes of Health (NIH) Center for Information Technology (CIT). The intent of the requested Congressionally mandated (earmark) follow-on sole source award is to expand the capacity of the CNTR research repository infrastructure and sustain its deployment through the DoD supported and funded Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System (IS) at the NIH, built on the BRICS, where it will receive, store, manage, process and share data from all federally funded clinical trauma research studies, both new and legacy. The legacy data that only the CNTR possesses along with new trauma data are a critical required capability that the data management system be able to accept, format and harmonize from multiple studies allowing the data to be pooled to create larger data sets suitable for secondary analysis, yet maintain a link between each datum and its original study. Any firm that has questions regarding this notice of intent (Congressional Earmark) are invited to submit written notification to the Contract Specialist NLT 12PM ET 14 December 2022. No telephone questions will be accepted. Questions received will be reviewed and responded to; however; a determination by the Government not to compete the proposed requirement (due to a mandated Congressional earmark) is solely within the discretion of the Government.