Data Management & Information Systems
The DM&IS Core develops state-of-the-art systems that can be accessed from any electronic device.
Data Management and Information Systems Core
We develop state of the art data management systems that can be accessed from any electronic device. We customized each data management system that is designed to facilitate the workflow of the study. We work with the investigative team to develop the case report form and an integrated tracking system. All of our data management systems have the capability to incorporate electronic health record data. All of our systems are developed using .NET 2.0 to create the interface and SQL for the database.
Our team can create a data management system that adheres to current data security practices, including the guidelines for FDA's Title 21 CFR Part 11 federal regulations.
In addition to the data management system, to design a web presence that helps investigators disseminate information or recruit participants.
Examples of Services for Research Studies:
- Forms consultation and design
- Paperless data collection including dynamic validation for range and logic checks and missing value
- Paper-based data collection including double data entry verification
- Automated randomization for clinical trials
- Interactive tracking for recruitment, screening and follow up
- Customized interfaces for researchers and/or participants
- Customized online and printed reports for recruitment, tracking and follow up
- Customized user documentation such as data dictionary and codebook
- Customized user training on data management and tracking systems
- Mass emailing
- Automated email reminders
It is the Data Management Core’s responsibility to develop and maintain state of the art data management systems that can be used securely from any electronic device. Each data management system is designed to facilitate the workflow of the study, and the Data Management Core works with the project team to develop, program, and maintain a unified application that meets the data collection, data integrity and tracking needs of the entire project.
- Information Systems Manager
The Information Systems Manager oversees all data management projects, meets with potential investigators and other clients to provide cost estimates for their projects, supervises systems programmers and other data management staff, and provides technical support to faculty, staff, and investigators.
The Systems Programmer works independently or with a Data Management Coordinator to determine project requirements and develop and maintain a quality application that fulfills the project needs, in a timely and effective manner and within the guidelines of best practices of research and programming standards. The programmer is responsible for ongoing support of the application in the event that modifications are required. All Systems Programmers are also responsible for monitoring requests that come in through the DCWEB help desk. Typically the programmer assigned to the source project will pick up the request and info the others s/he has taken responsibility for the request. Requests must be monitored and resolved in a timely manner. In the event that an urgent request is made when assigned personnel are unavailable, available DC personnel will temporarily take responsibility for the request and resolve if possible and feasible. All programming related requests are sent to email@example.com so that DC programming staff can see the request and handle appropriately.
Cutting Edge Server Resources
The CRHC DC maintains numerous servers and personal computers, which provide access to both the Internet and the CRHC DC intranet. Servers are located in a secure server room, which contains an alarm system, temperature control, and a double lock on the main door with a tracking key card entry system. All servers use hardware fault tolerance methods to assure the continued availability of data.
The CRHC Data Center maintains (Server Details):
Web servers utilizing 128-bit SSL security for online real time data entry.
SQL servers, for database and data storage, with 128-bit SSL security and limited access via network firewall.
Web site and database development servers located behind a firewall accessible only to developers on the intranet.
Data warehousing and file sharing servers only accessible by individuals on the intranet.
High-end servers dedicated to statistical analyses, containing 8 Xeon processors and 32 GB RAM with stripped raided SCSI high end performance hard drives.
Data Security Matters.
Data security is an important factor to consider in the data collection process. Making sure that data is secure from unauthorized changes or access is important to ensure the data’s accuracy and integrity. In this vein, the Food and Drug Administration (FDA) developed guidelines (Title 21 CFR Part 11) for electronic records to ensure the integrity and reliability of the electronic data. Our database systems adhere to the FDA’s Part 11 guidelines.
Some of our unique policies include:
Access to data is controlled through password and authentication policies
- Only approved individuals have access to data
- Password policies control the length and variability of the user password selection
- Audit trails implemented to log date, time, individual, changed values, and rationale for all data changes
Validation is programmed directly into the project application in order to reduce the possibility of errors in all phases of the study
Additional tools for verifying the data are
- error checking reports
- double data entry
- and verification for paper forms
Backup & Version Control
Our dedicated SQL server, which is used for database and data storage, offers 128-bit SSL security
- Our dedicated web site and database development server is located behind a firewall with only developers on the intranet having access
- The Data Center programmers use version control software, TortoiseSVN, to manage changes made to databases and websites.
- All revisions are kept and can be accessed by the programmer