DEPARTMENT OF EPIDEMIOLOGY & BIOSTATISTICS - SERVICES

Consulting

One of the missions of the Department of Epidemiology and Biostatistics (DEB) is to provide consulting services to assist University of Texas Health Science Center at San Antonio faculty, staff and trainees in the planning, conducting and reporting of biomedical research investigations. Significant resources and infrastructure have been developed within the Department to support this mission; however, a chargeback mechanism for consulting services is required in order to financially support the development of new research, to incrementally cover direct costs associated with this research; and to provide the added infrastructure required to accommodate the growing research base of the University. Consultative services are focused in several key areas including: study design, statistical planning, data management, statistical analysis and reporting. Collectively, the provision of these services requires diverse domain expertise represented by the disciplines of epidemiology, biostatistics and biomedical informatics. In addition, these services reflect support not only for the research mission of the University but also for the educational mission by supporting the training of UT Health Science Center faculty, staff and students in the conduct of biomedical research. The following activities characterize our service mission:

  1. Provide support for the design on new research studies/grant applications, including biomedical, clinical trial and clinical translational research study design; provide assistance in developing statistical analytic plans including definition of study hypotheses, study objectives, study endpoints; help develop safety and efficacy monitoring plans for clinical research investigations; develop sampling strategies; conducting interim and final statistical analyses; and assisting with the development of study reports, manuscripts and presentations.
  2. Provide assistance to aid junior investigators as they develop their research programs, conduct preliminary studies, publish manuscripts and prepare grant and/or career development award applications;
  3. Engage investigators in the collaborative process during the initial stage of study planning;
  4. Apply state-of-the-art exploratory and confirmatory statistical methods to optimize the reliability and generalizability of the data produced by UT Health Science Center investigators.
  5. Provide a complete range of computer informatics and data management support services, including assistance with the collection of biological (including high throughput) data, clinical data, population-based research study data; linkage with external datasets; and development of computer interfaces to assist with data entry and management operations; preparation of dataset for statistical analysis and reporting.

BIOSTATISTICS/EPIDEMIOLOGY SERVICES

A three-tiered service level classification has been established. Assignment to a tier is based on the level of expertise and complexity of support required:

  • Tier I services provide short-term consulting support for straightforward research projects that have a well-defined goal. Examples include the development of an abstract for a scientific meeting or an analysis for preparation of a manuscript. These are usually one-time research activities typically done by more junior faculty, masters-level staff or graduate students.
  • Tier II services provide longer-term support for junior and senior faculty developing and conducting individual investigator initiated grant applications or research protocols. Our expectation is that we will engage investigators early in the process of developing grant applications and protocols. For Tier 2 projects, we provide high-level advice on optimal experimental designs or study designs, development of statistical models, and comprehensive analysis plans appropriate to the research problem. We also provide sample size determinations or statistical power estimates. Typically, junior faculty will be paired with senior DEB faculty who will assume the role of mentor, as well as collaborator in order to foster career development for these younger investigators. We will continue to work with the investigator throughout the entire application process including response to reviewer comments until the grant is funded or response to protocol reviews. Once grants are funded or protocols are initiated, DEB faculty collaborators continue to work closely with the investigator to coordinate research resources, monitor study progress, and ensure that the project is executed in a sound scientific and ethical manner.
  • Tier III services expand the scope of functions to assemble and coordinate a larger array of resources for larger clinical and translational research efforts. These include provision of biostatistical core support for large, multi-site clinical trials, program project grants, and center grants.

BIOMEDICAL INFORMATICS SERVICES

DEB Information Systems (IS) staff provides support to investigators through specialized data management and software development services. The specialized nature of their work in the clinical research arena assures that IS staff are: 1) well versed with industry-standard regulatory standard techniques and procedures; 2) have met specialized local, state, and federal training requirements; and 3) ensure software and data applications conform to the necessary legal requirements. Informatics services fall into “Data Management” and “Software Development” categories.


Data Management is the development and execution of architectures, policies, practices and procedures that properly manage the full data lifecycle needs of a project, protocol, system, or enterprise. Areas of expertise include but are not limited to:

  • Data Analysis: Data analysis entails looking at and summarizing data with the intent to extract useful information and develop conclusions. Informatics data analysis is distinguished from statistical data analysis in that it is focused on determining how to structure and quantify what has already been determined to be necessary to collect. For example, IS staff work with investigators in creating and defining a protocol’s data case report forms (CRFs).
  • Database Management and Administration: Managing the software programs and servers that control the organization, storage, management, and retrieval of data in a database. Database administration is the oversight of the environmental aspects of database operations. In general, these include:
    • Recoverability—Creating and testing back-ups
    • Integrity—Verifying or helping to verify data integrity
    • Security—Defining and/or implementing access controls to the data
    • Availability—Ensuring maximum up-time
    • Performance—Ensuring maximum performance given budgetary/resource constraints
    • Development and testing—Helping programmers and engineers to efficiently utilize database resources
  • Data Modeling: Structuring and organizing the data by defining and creating data structures in the database management system. In addition to defining and organizing the data, data modeling will impose (implicitly or explicitly) constraints or limitations on the data placed within the structure.
  • Data Migration: Also known as Extract, Transform, and Load (ETL), this is the process of data warehousing that involves:
    • Extracting data from outside sources
    • Transforming data to fit business needs (which can include quality levels) through data cleansing or data scrubbing (the act of detecting and correcting or removing) corrupt or inaccurate records from a record set, table, or database, and data mapping (developing appropriate data coding translation tables)
    • Loading data into the database
  • Data Quality Assurance: profiling the data to discover inconsistencies, errors, and other anomalies in the data and performing data cleaning activities to improve the data quality

Software Development is the translation of an investigator-need into a software solution and product. The software development process is the same for all projects; however, the effort and its associated financial costs are proportional to the scope and scale of the project. With our experienced leadership, we assign the appropriate DEB IS staff to specific components of projects. The DEB software development process is not a one size fits all process. We encompass software engineering combined with understanding the research in order to develop computer software products. Software development components include:

  • Requirements Analysis: Determining the needs or conditions for a new or altered product, accounting for the possible conflicting requirements of the various stakeholders, such as beneficiaries or users. Requirements must be actionable, measurable, testable, related to identified business needs or opportunities, and defined to a level of detail sufficient for system design.
  • Project management: Organizing and managing resources (e.g. people) in a manner which ensures that the project is completed within the defined scope, quality, time and cost constraints.
  • Programming: Writing, testing, debugging/troubleshooting, and maintaining the source code of computer programs. DEB source code typically is written using Open Source tools and web-based programming language.
Table 1. Matrix of Support Activities and Services
DEB Service Activity Level I Services Level II Services Level III Services
Study Design and Statistical Analysis Limited consultations and proposal development Extensive consultations and initial advice on all projects Data analysis, study design, model development, regularly scheduled consultations, etc.
Data Training Training Seminars Focused and individualized Training Providing project specific training blocks for data collection and analytical methods. This would include the training of project staff.
Data Management Limited consultations and proposal development Ad-hoc consultations and initial consultations on all projects Building databases, cleaning data, performing data conversions, creating codebooks, regularly scheduled consultations.
Any specialized needs for data access that would require additional programming or data security measures beyond standard procedures.
Software Development Initial consultations for proposal development Standard web services related to project management and data acquisition and entry Any specialized development pertaining to interactive data entry or data access via the web.


To inquire on fees associated with any of these consulting services please send your inquiries via e-mail to the following:

Daniel Anzak
Administrator
Department of Epidemiology and Biostatistics
anzak@uthscsa.edu

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