Proposal Boilerplate

The FIU-STATCONSULT has the mission to enhance FIU’s research endeavor by providing infrastructure support relevant to biostatistics, bioinformatics, data management and data quality enhancement. It supports investigators and graduate students for proposal preparation, study design, data collection, data management, statistical analyses, study operations, report and manuscript preparation and going beyond the typical CTSA sponsored Biostatistics Cores at other universities.  It is integrated both in terms of drawing on expertise from and providing support to investigators across and beyond FIU.  It works in close collaboration with the Center for Children and Families (CCF) of the College of Arts and Sciences, the Herbert Wertheim College of Medicine and Nicole Wertheim College of Nursing and Health Sciences. It also collaborates with entities outside the university. All FIU-STATCONSULT personnel (faculty and staff) are required to be certified to have had training in human subjects’ research, HIPAA and data security awareness.

Since its inception, the FIU-STATCONSULT has provided support for more than 860 projects, 474 investigators, mostly FIU faculty and students, representing over 125 departments, 22 colleges and centers and 33 organizations outside FIU.  Activities range from implementing surveys and data collection using REDCap and other software packages to more in-depth support for larger, long-term projects.

Information Systems Support. Computational and information systems support—apart from the desktop machines in individual offices, we also utilize the services of the FIU Data Center of the University Division of Information Technology, which houses server support for REDCap data management software. Planning, configuration and end-user support for FIU REDCap (https://redcap.fiu.edu/) is provided by the FIU-STATCONSULT for various projects.  REDCap servers are housed in the Amazon Web Services (AWS) Cloud, which is comprised of different geographical regions and availability zones across the country to ensure scalability and redundancy in the environments.  All web-based transactions are encrypted in transit and the data at rest is also encrypted.  At Amazon, electrical power systems are designed to be fully redundant so that in the event of a disruption, uninterruptible power supply units can be engaged, while generators provide backup power for the entire facility.  People and systems monitor and control the temperature and humidity of all equipment to prevent overheating, further reducing possible service outages.  To ensure security, the REDCap environment in AWS is comprised of several security groups that act as virtual firewalls in order to control inbound and outbound traffic as well as prevent unauthorized access to the servers.  In addition to the security applied to the servers, users accessing the REDCap application must use the two-factor authentication (2FA) method, which strengthens access security by requiring two methods of authentication (password and a device) to verify their identity, which protects against phishing and password brute-force attacks as well as secures logins from attackers exploiting weak or stolen credentials.  Software engineers within FIU Data Center perform software maintenance and upgrades under the direction of, and in concert with, the CCF’s Data Manager. The Division of Information Technology Security Office (http://security.fiu.edu) provides Policies and Standards related to physical and technical security, contingency planning and incidence response that align with the University Compliance Office policies and procedures regarding Health Information Privacy.

Statistical Computing. The Center provides statistical computing, data management, and report generation support and participate as members of the teams for individual projects.  As indicated below, all the usual and expected software and computing facility are available.

Bioinformatics Core. Statistical Machine Learning Group (SMLG) in Department of Biostatistics provides Bioinformatics and Biostatistics support to researchers inside and outside of FIU. SMLG mainly analyze big and complex data using Big Data Analytics (BDA), e.g., statistical and machine learning methods. Projects of SMLG ranges from clinical translational models to gene-gene and gene-environmental interactions in chronic diseases using BDA. SMLG also closely collaborates with Bioinformatics Research Group (BioRG) under Computer Science at FIU.

Facilities, Hardware and Software. Facilities include faculty offices provided by departments as per usual university operation, one office suite including a conference area with video conferencing capability and cubicle space for 4 staff/students, and offices for four persons, all outfitted with appropriate hardware and the usual collection of office software.  Available also are the data management packages REDCap, Qualtrics, among others and the statistical software SAS, R, SPSS, STATA, Mplus, NQuery, and PASS.  All offices and cubicles have relatively new computers—we use a three-year renewal cycle—while some have the additional capability required for effective simulations, houses servers and storage equipment required for handling REDCap and other systems. SMLG has five state-of-art linux servers with 3.6GhZ CPU with RAM ranging from 32GB to 128GB suitable for computationally intensive BDA research.

Planning, configuration and end-user support for FIU REDCap (https://redcap.fiu.edu/) is provided by the Data Services Group of the CCF and FIU-STATCONSULT for non-CCF projects.  REDCap training provided to investigators/study staff to ensure integrity of electronic data capture by Recharge Center rates. REDCap servers are housed in the Amazon Web Services (AWS) Cloud, which is comprised of different geographical regions and availability zones across the country to ensure scalability and redundancy in the environments.  All web-based transactions are encrypted in transit and the data at rest is also encrypted.  REDCap environment in AWS is backed up on a daily basis with 7 days retention. This includes taking daily snapshots of the encrypted volume disks and backing up the systems via Druva should we require file level recovery. At Amazon, electrical power systems are designed to be fully redundant so that in the event of a disruption, uninterruptible power supply units can be engaged, while generators provide backup power for the entire facility.  People and systems monitor and control the temperature and humidity of all equipment to prevent overheating, further reducing possible service outages.  To ensure security, the REDCap environment in AWS is comprised of several security groups that act as virtual firewalls in order to control inbound and outbound traffic as well as prevent unauthorized access to the servers.  In addition to the security applied to the servers, users accessing the REDCap application must use the two-factor authentication (2FA) method, which strengthens access security by requiring two methods of authentication (password and a device) to verify their identity, which protects against phishing and password brute-force attacks as well as secures logins from attackers exploiting weak or stolen credentials.  Software engineers within FIU Data Center perform software maintenance and upgrades under the direction of, and in concert with, the CCF’s Data Manager. The Division of Information Technology Security Office (http://security.fiu.edu) provides Policies and Standards related to physical and technical security, contingency planning and incidence response that align with the University Compliance Office policies and procedures regarding Health Information Privacy.