Study Design and Biostatistics (SDAB)
Data Management Assistance
The SDAB Core supports the investigators in making database and data management decisions and complying with regulatory issues relating to confidentiality and security of data. In this capacity, core members work directly with the ITMAT Center for Biomedical Informatics in Translation (BIIT). Appropriate data capture is crucial to the validity of not only to the overall integrity of a study, but also to statistical analysis. For example, many methods for longitudinal data analysis require repeated measurements on subjects to be in rows, rather than columns. Consultation on this type of issue at the design stage of a study can considerably reduce work required to transform datasets at the analysis stage. Core members consult with the entity that will manage the data and define clearly the statistical needs in order to later support the analysis of the data.
With the availability of REDCap, investigators are encouraged to use it or similar systems for analysis, rather than simple spreadsheets. Dr. Cucchiara serves as a consultant for investigators intending to use that resource. More complicated studies, or trials subject to a strong regulatory component, may require the use of Oracle Clinical. BAC members in the SDAB Core have extensive experience coordinating data management and analysis of data from Oracle Clinical in collaboration with BIIT, and will continue in the next period. These tasks include the overall data structure, data formats, creation of derived variables, and identification of potential data entry errors or outliers. Analysts may also be involved in the creation of validation rules at the database level, determining what types of checks and cross-form checks are needed in real time. These tasks outline an important collaboration with the BIIT, who also provide consultations in turn.