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  • Core D | Core Facilities

    Core E: Study Design and Clinical Research Core Services

    David Graham, M.D., Director
    Hashem B. El-Serag, M.D., M.P.H., Co Director
    Claudia A. Kozinetz, Ph.D., M.P.H., Co-Director

    Services and Functions Available

    Study Design Services

    Service/Function

    Description of Service/Function

    Sample size/Power Estimates

    Provides formulas, calculations, assumptions via a matrix with detailed explanation and justifications.  Provides education regarding the meaning and importance of sample size issues.  Provides training on the use of sample size/power software.

    Design and Development of data collection tools

    Provides assistance with variable selection and inclusion, coding and making sure that data collected via the tools can be subjects to statistical analysis.

    Randomization schemes

    Electronic generation of randomization lists for clinical trials.  Provides training on the used software for generating randomization lists.

    Review chance, bias, confounding

    Reviews grant applications for study design issues which should be corrected for more sound research project.

    Determine appropriate study design

    Via consultations with investigators will determine the most appropriate study design to use to address the primary research question

    Data Management Services

    Service/Function

    Description of Service/Function

    Instruction/assistance with procedures for design, development and maintenance of study-specific databases

    Discuss software available, share Manuals of Procedures for databases, create databases for users to use for data entry

    Statistical Analysis Services

    Service/Function

    Description of Service/Function

    Conduct statistical analysis

    Provide univariate and multivariate analyses as appropriate for the research question.  Provide detailed explanation and report of analyses.  Techniques include but not limited to: descriptive analysis, t-test, chi-square, ANOVA, repeated-measures ANOVA, Odds ratios, Risk ratios, survival analysis (Kaplan-Meier, Poisson), logistic and probit regression, Multiple regression, Cox regression, generalized estimating equations, Random Effects Models, Fixed Effects Models, Maximum Likelihood Estimation, Generalized Linear Models.  Conduct series of lectures on statistical analysis techniques.

    Data interpretation

    Review statistical analyses plans for appropriateness, and assist interpretation of statistical analyses conducted by users.  Suggest additional or alternative techniques.

    Biostatistical co-investigator

    Serve as biostatistical co-investigator on grant application

    IRB/Grant Preparation Services

    Service/Function

    Description of Service/Function

    Statistical analysis of pilot-preliminary data

    Assist preparation of data presentation for grant application

    Assistance with writing grant sections on plan of analysis/sample size

    In collaboration with investigative team, develop appropriate sections for IRB/grant applications.

     

    Clinical Specimen Core Services

    Service/Function

    Description of Service/Function

    Processing mapping for a project

    Assistance in development of budget, project milestones, and timeline, definition of local clinical resources, identification of key personnel, development of Q/A controls, and work flow

    Assistance in obtaining clinical specimens

    Identify the needs in terms of the type of specimen and the requirements for processing etc. to ensure it can be sued for the purpose.  Identify sites where specimens can be obtained locally, nationally, or internationally and either make the arrangements or assist in making the arrangements.

    Identify patients for specimens

    Services range from providing surveillance for appropriate patients so that they will not be missed to actual patient identification and specimen collection, processing and transport to the investigator.

    Transport of specimens locally, nationally, or internationally

    Assist in arranging for National or International shipment of specimens including obtaining appropriate approvals from the CDD or USDA as well as complying with all international and national regulations regarding shipping

    Appropriate IRB approvals

    Provide advice or actual hands on completion of the documents required to obtain IRB approval including HIPPA regulations, development of a consent form, and obtaining approval at the various sites locally and outside of our medical center if needed.  Assist in communications with the various IRB boards. Arrange for updating of the protocol annually.  Provide assistance with reporting of adverse events and protocol violations. 

    Obtain an IND or IND waiver

    If an IND or IND waiver is required, assist in preparation of the appropriate documents.  Assist in responding to queries from the FDA and in providing the required updates and reports.

    Establish a study binder

    Provide examples and help in establishing a study binder that contains all of the required documents in the appropriate format.

    Establish a database

    Assist in identifying the items that should go into the database.  The actual database construction would be done with the assistance of the statistical portion of the core.

    Construct data collection forms

    Design data collection forms that provide the needed information, such as inclusion and exclusion criteria, appropriate check points (e.g., consent signed), for the study to provide analyzable data.

    Establish a data safety monitoring board

    Assist the investigator in identifying individuals to service on a data safety monitoring board and helping establish the board as well as the SOP for the operation of the board.

    Please credit the "NIH/National Institute of Diabetes and Digestive and Kidney Disease, Center Grant P30 DK56338" in publications resulting from core usage or pilot funds.

    Core D | Core Facilities