Stan Ahalt, MA, PhD
Javed Mostafa, MA, PhD
Larry Klein, MD
Don Spencer, MD, MBA
Stan Ahalt is the current director of Biomedical Informatics and Javed Mostafa serves as assistant director. Biomedical Informatics offers numerous services geared toward improving the feasibility and efficiency of research. The Carolina Data Warehouse – Health (CDW-H) is led by Dr. Don Spencer and is collaboration among UNC faculty, staff, and IBM personnel with expertise in health care research, informatics, and data management. Dr. Javed Mostafa has led the development of a critical CDW-H application called the Research Portal, which is a gateway for investigators to conduct searches for research cohorts and to store the transaction results for subsequent analysis and use. The Data Management Service Initiative is led by Dr. Lisa LaVange and comprises a collaborative effort between the Biostatistics Core and Biomedical Informatics Core. The Biomedical Informatics Education Initiative is led by Dr. Javed Mostafa and includes Carolina Data Warehouse – Health
, Biomedical Informatics Education Initiative
, Data Management Service Initiative
, REACH NC
, Clinical Research Management System
, IRB Process and Tools
, TraCS Central
, Internal Grants Management
, Hospital Research Billing
Carolina Data Warehouse – Health (CDW-H)
The Carolina Data Warehouse – Health (CDW-H) is led by Dr. Don Spencer and is collaboration among UNC faculty, staff, and IBM personnel with expertise in health care research, informatics, and data management. Dr. Javed Mostafa has led the development of a critical CDW-H application called the Research Portal, which is a gateway for investigators to conduct searches for research cohorts and to store the transaction results for subsequent analysis and use. Dr. Larry Klein is a collaborating faculty physician providing clinical informatics and medical record data expertise to the program.
Biomedical Informatics Education Initiative
The Biomedical Informatics Education Initiative is led by Dr. Javed Mostafa. He is actively planning the development of the Clinical Informatics Master's Degree program, certificates, and courses with partners from a wide variety of disciplines including Medicine, Public Health, Information and Library Science, and Nursing.
Data Management Service Initiative
The Data Management Service Initiative comprises a collaborative effort between the Biostatistics Core and Biomedical Informatics Core. Fully hosted, web-based solutions are available and can be customized to support local and multi-site clinical research studies. Key objectives of the initiative include (1) motivating the use of standard forms and database structures across NC TraCS protocols, (2) promoting high quality data capture & security, and (3) providing faster systems implementation with reduced overall costs.
This initiative seeks to implement a research networking interface to support identification of potential research collaborations based on keyword searching. This TraCS co-led effort was adopted by the UNC System General Administration (GA), and a pilot implementation is now live with searchable profiles for all UNC and NC State faculty. GA has obtained agreement to participate from the 14 other UNC System schools, Duke University, and Wake Forest University. (This totals over 17,000 faculty).
Clinical Research Management System (CRMS)
Our investigators have consistently identified barriers to clinical research resulting from the time required to get a study started, the lack of visibility to the total process across multiple campus offices and the need for duplicate data entry to those offices. In addition, there is an institutional need to better assess financial viability and regulatory compliance related to clinical research efforts. TraCS in collaboration with the Office of Research & Economic Development initiated development of the UNC Clinical Research Management System (CRMS). This application links isolated research support systems on campus, provides process guidance to research teams and presents an integrated view of the pre-study process, while moving legacy paper-based processes to an online environment. The initial release of the CRMS, which contains budget building and feasibility testing functionalities, was deployed in July 2010 and is being piloted by 10+ clinical research groups within the School of Medicine. Online submissions and integration within campus offices is targeted for Q1 2011.
IRB Process and Tools
Another key initiative where TraCS has partnered with the Office of Research & Economic Development to enhance research administration across UNC is an online tool for submission of IRB applications. This new tool will share data with the Clinical Research Management System to save steps in data entry and provide a unified process dashboard to investigators. In addition, the TraCS Regulatory Core has integrated the CTRC application process into the new online IRB tool. The CTRC has also streamlined its review process, opting for full reviews only in the case of an investigator initiated protocol and handling all others with a modified staff review, similar to and concurrent with that of the IRB model. Going forward, TraCS is partnering with the IRB to explore a pilot project in which selected multi-site trials will utilize external IRBs. Data from this effort will be gathered for comparison with the internal IRB.
TraCS Central – Communications Hub and Project Tracker
The goal to broaden engagement involves reaching out to local UNC staff and researchers, as well as the community-at-large, which includes other government, educational, and private sector organizations. To help facilitate this engagement, a web-based request and project tracking system, named TraCS Central, has been developed. The system enables the capture of requests via phone, email, and self-service forms on the TraCS public website. Critical data associated with requests as they evolve into projects are also collected in the database such as the initiator’s contact information, responder’s contact information (e.g., a core and personnel in the core), data approval status, and proposal submission status. The system also allows TraCS cores and programs to define customized data collection forms tailored to their specific needs. TraCS Central is a crucial tool not just for the provisioning of effective service to our community but it is also a powerful record-keeping tool for NIH/NCRR reporting needs. This system is operational and it is currently a major software application used by TraCS for project tracking.
Internal Grants Management
To enable a streamlined proposal submission and management process for external funding opportunities, UNC implemented an online application, RAMSeS, prior to the CTSA award. TraCS is now leading an effort to extend this system’s capabilities to support internal funding opportunities such as the TraCS Pilot Awards. The enhanced system will provide opportunity advertisement, proposal submission, review and scoring by faculty reviewers, and award tracking and administration. A key objective of this effort is to provide this functionality to any UNC organization unit. A pilot release of this enhanced system will be online by Q2 2011.
Hospital Research Billing
During the requirements gathering phase of the CRMS initiative, UNC Research Coordinators rated revision of the UNC Healthcare Research Fee Schedule as their highest priority for improving both the efficiency and accuracy of study financial management. Enabling accurate searches and providing clarity about matching procedures to fees were seen as critical. TraCS staff participated in a series of meetings with representatives from multiple UNC Healthcare departments, including the Compliance Office, and helped to identify a set of recommendations to address these issues. This effort has also led to a sub-project which is investigating the overall research billing processes across clinics, labs, the pharmacy, and patient accounting.