Shared high speed workstation with dual Xeon 3.6 GHz processors, 4 GB of SDRAM, over 800GB of high speed storage, digital tape backup, and a DVD read/write drive. Five Dell 2.4 GHz computers with 40 GB hard drives and 512 MB DDR RAM; one Dell 2.4 GHz Xeon with 120 GH hard drive and 1 GB RDRAM; 2 Dell Pentium 2 GHz laptops with 100GB hard drive and 1GB SDRAM.
Statistical, Mathematical and Database Software
SAS, Minitab, S-PLUS, LogXact, StatXact, EGRET, SOLAS, WinNonlin, Nquery, Mathcad, DIGITAL Visual Fortran Professional, DBMSCopy, SigmaPlot, Excel, Access, MS SQL, OmniForm, Oracle, MS Visual Studio, Resampling Stats.
Networking and Internet
Dell PowerEdge 4600 file server with a 2GHz Xeon CPU, 2GB of DDR SDRAM, six 18GB SCSI Hard Drives in a RAID 5 configuration, 200GB digital tape backup system. Novel Netware 5.1 Network Operating System; Internet Explorer 6; GroupWise email; Internet 2 access through KUMCs LAN.
The Department also has two Dell PowerEdge 1850 production servers as well as a Dell PowerEdge 1850 server test environments for their Informatics initiative. A Dell PowerVault tape backup is also located in the server room along with a cooling system to maintain optimal conditions for optimal server performance. Tape backups are performed daily on modified data and full tape backups are performed weekly and stored off-site for 9 weeks.
The Department of Biostatistics and Center for Biostatistics and Advanced Informatics continues to provide informatics support to the KU Cancer Center and various components related to this center, the General Clinical Research Center (GCRC) and is currently developing a comprehensive prostate cancer database for the Kansas City Veterans Affairs Medical Center and other VAMCs. The Department has been involved in the development an implementation of an online submission and review process for GCRC protocols. The Department has been involved in the development of over 60 Access study databases as well as several databases developed using Omniform. Department staff has developed a number of touch screen kiosk programs which allow for data collection in the community. In addition to touch screen kiosks, Department has developed touch enabled tablet pc and pocket pc (PDA) programs which further enable novel individual interventions and data collection.
The Department is able provide support related to data capture form design and database design and development as well as administrative informatics support for various grants and projects. Support includes, but is not limited to; training of research investigators and staff, data collection form construction, data management, security and maintenance, system administration and oversight, web and online review processes, generating ad hoc queries and reports, creating interfaces to integrate third-party data as well as exporting data to the biostatisticians for analysis.
A major informatics initiative of the Department in partnership with the KU Cancer Center is the implementation of a comprehensive clinical trials management system. This system will support research activities and information related to: patient recruitment, study monitoring, trial design, protocol management, and data safety monitoring; case report form construction and dissemination; integration of tissue and clinical information; clinical trial execution and query management; and integration with third party clinical systems. The comprehensive clinical trials management system is HL-7 compliant system and is configured to easily integrate with internal as well as third-party lab systems, Electronic Medical Record systems, etc., through one integrally-designed system. The comprehensive clinical trials management system has included in its software programming to maintain compliance with CFR Part 11 as well as various industry and federal standards. The system can support multi-center, cooperative group and investigator-initiated research through advanced technology and security features, all contained in one comprehensive environment. Through utilization of this comprehensive system great improvements in the research productivity, efficiency, collaboration and integrity of data can be achieved.
The Department continues to work with investigators to determine their information management needs. The Department offers a secure web-based Clinical Information Management System such that data and protocol information can be entered efficiently and in a standardize format compliant with various reporting standards. Data is entered by site personnel according to established protocols for each project. Data is collected and entered according to Quality Assurance and Quality Control Standard Operating Procedures of the Department as well as in compliance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in order to protect the privacy of research participants. All electronic and paper data is kept in secure, password protected electronic files/systems or in locked file cabinets. Access to these records is strictly limited to persons whose research responsibilities make it absolutely necessary.
Some data are collected electronically and sent to the Department directly, eg lab data, are merged with this clinical information. All manual data entry is performed by study specific personnel and if double data entry is required, this is available through the Department at a minimal charge. Data is verified by edit, logic, range, and missing data checks. Queries on these checks are sent to the site of data acquisition for resolution. Once all of these checks have been passed and/or resolved the data is downloaded into the specific projects central database. Data collected in laboratories via computing systems also go through range, edit, logic, and missing data checks as developed in collaboration with the Department and the investigator(s). Again, once all checks are passed the data is downloaded into each projects central database.
Data will continue to be downloaded to each projects central database as it is acquired and meets all checks. The central analytic databases are SAS databases and are collections of the raw data from each data source. Specific identifiers will be established to insure linkage of all data on an individual or animal within a study database. Functions of variables will be added to each database upon the approval of the projects primary investigator and Dr. Mayo. If investigators wish to have their databases in a format other than SAS, the Department can convert them into over 80 different formats.