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Data Management

We are a multi-disciplinary team of professionals with years of experience in clinical, behavioral, and observational data management, software/web application development, and IT systems/database management.  We have invaluable experience in supporting single and multi-site studies, fulfilling data coordinating center (DCC) obligations, and collaborating with statisticians to ensure robust statistical analysis.  We follow good data management practices through a formal and systematic approach in a study’s life cycle for the collection and retention of research data in order to:  protect the data, manage its quality, prepare it for analysis and reporting, and, sustain access and preservation for use by researchers over time, "... I never have to worry about data management here at IU; I know this aspect of my work is in great and safe hands." -- S.K. Gupta

Our data managers (DMs) are the “front-liners” who collaborate with you in managing the quality of the data from study start-up through study closure.  They develop the data management plan to ensure that data collected will be consistent with the grant protocol and planned analyses.  Our DMs assist with the design of:  data collection forms, customized data management systems, and quality assurance/quality control (QA/QC) measures.  They develop REDCap project databases and surveys to support small scale projects and they leverage TELEForm® for projects that need data collected on scannable forms.  In preparation for data analysis, our DMs use SAS® and SQL to generate preliminary statistics, perform QA/QC measures, prepare summary reports, and create analysis data sets.  "... The data managers are knowledgeable, willing to learn about clinical care in order to provide more informed input into the process, and exceptionally diligent in ensuring that the data is up to research standards." -- K. Wools-Kaloustian

Our software/web application developers implement customized data collection systems specific to your study.  In addition to the functionality required to enter the core study data, they develop modules to support subject tracking and scheduling, specimen inventory and tracking, lab analysis results, overall study operational logistics and administration, on-line reports, and so forth.  Our team will work with you in defining the requirements and will seek your input during the course of the development efforts.  As the study moves from start-up to conduct, they will continue to provide technical support on an as needed basis.  Our custom web applications are primarily developed using Microsoft .Net and SQL Server Database technologies.  We have experience in developing applications for use with mobile devices and have experience with Java, MySQL, and other open source development technologies.  "... I’ve always found the staff responsive and capable, innovative, and willing to engage many, many challenges." -- J.D. Fortenberry

Our Information Technology (IT) team administers the IT infrastructure (servers, databases, software) required to support the application(s), web sites, file shares, etc., for your study and to ensure appropriate measures are implemented to secure and protect your data in accordance with HIPAA guidelines.  They consult, advise, and recommend technical solutions and will assist with researching and procuring study specific hardware and/or software.  Security protocols, data backups, and documentation are integral to our operating procedures.  "... These professionals went above and beyond what would be reasonably expected." -- S.E. Clare

Our data entry clerks provide support to your study by offering services such as printing paper forms, scanning and verifying data collected via scannable forms, i.e., TELEForm®, transcribing data from paper forms to an electronic data entry system such as REDCap, and preparing randomization envelopes.

The composition of our data management team assigned to your study would vary depending on the extent of the study.  One study may involve just one data manager but another might include multiple DMs, an application developer, and a data entry clerk.  In any case, we strive to tailor the skills and experience of our data management team to closely meet your study needs.  "... I have been very impressed by their professionalism, creativity, the wide variety of expertise available to bring to the project and the outstanding coordination and integration of various sub disciplines to achieve timely and well-crafted deliverables." -- M.K. de Groot

Department of Biostatistics | 410 W. Tenth St., Suite 3000 | Indianapolis, IN 46202 | Ph: (317) 274-2661 | Fax: (317) 274-2678