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Biomedical/ Clinical Information Technology Solutions

DCU provides state-of-the-art computer technology solutions in internet-based connectivity for clinical trial investigators and participants. DCU has kept innovating our system to allow for reliable and efficient data capture, transfer, and management by adopting several types of breakthrough computer technology.

If you want to know about the benefits and specific features of our latest system addition - WebDCU™, please go to Case Study page.
DCU’s medical informatics services include:

Integrated Solution

SRR Station: Subject Registration and Randomization System
Since the World-Wide-Web has become an essential tool in the performance of clinical trials, DCU information systems experts have designed a web-based clinical trial subject registration and randomization system. The SRR Station website provides increased speed, efficiency, and ease of use for the study coordinators. The website features subject eligibility checks, registration, screening logs, instantaneous receipt of treatment assignment under pre-specified randomization schemes, site-specific tracking of visit dates and specimen collection, and oversight of accrual by appropriate trial personnel. Full and partial blind control is included.
Rule-based Data Validation Process for High Data Quality and Integrity
In order to deliver the hightest level of data quality and integrity to the clinical trial and biomedical research arena, DCU has introduced rule-based data checking processes to our systems.

Data rules, including data range checks, data consistency checks and cross field/form logic checks based upon the data dictionary, are programmed into the system for automatic data checks. Automatic notification of rule violations (i.e., Warning, Error or Rejection) is displayed on the data entry screen for quick and efficient resolution at the site.

Although this requires intense programming in the initial stages of the study, the overall efficiency of being able to resolve data queries at the data entry phase and at the site level with a full audit trail proves to be a valuable system. All violations require resolution or explanation prior to data submission to the central database.

WebMonitor: Internet-based Study Monitoring System
The WebMonitor is designed for site research staff and project monitors to retrieve the most up-to-date information on the progress of studies they are involved in. Information available on this website includes subject registration, randomization and termination, CRF collection, data entry, data validation, data clarification request processing, and case report form tracking. The website helps the site research staff better manage their research activities and increases their awareness of the data management activities within DCU. The website provides services for multiple projects with project-limited user data access control.
Study Calendar: Subject Visit Scheduling Process
The future of site coordination will surely include the tools DCU can provide with our website. Patient-specific visit calendars can be generated based on predefined protocol schemes, as each patient is randomized. Clinical alerts and study notifications can be distributed seamlessly to sites and investigators over a secure password-protected web page accessible only to appropriate study staff.
WebDCR: Internet-based Data Clarification Request System
After entering data into the DCU information system, DCU may perform additional data quality checks, such as cross-form and cross-visit logic checks. Data managers review discrepant items and submit data clarification requests (DCRs) to the site via the web. The site replies to the web based requests and corrects the data, as needed. All changes to the data are tracked via an audit trail. By adopting this web based tool, DCU can convert the traditional time-consuming and cumbersome paper-based data cleaning into an efficient and accurate process.
Alternative: Traditional Database System
An alternative to DCU's web-based information system is the combination of traditional paper CRFs with web-enabled study management tools. This system houses the data in Clintrial®, an industry leading data management software and DCU's primary processing software. DCU uses Clintrial® as the primary paper-based data processing software and Oracle® as the back-end database system.

Double data entry, rule-based data validation and standardized coding algorithms are used to ensure high data quality. The Clintrial® database contains field types that are most conducive to capturing data and are identical to the CRF. This minimizes data entry errors, streamlines the database development process, and allows for increased communication between the site personnel and the DCU Data Manager. Upon completion and review of a CRF, the researcher transfers the original CRFs to DCU for processing while retaining a copy for the study file.

DCU has developed a process for tracking CRFs that has proven to be efficient without decreasing quality. The progress of individual CRFs is tracked through DCU's Trial Tracking System (DCU's own comprehensive trial management database). The system consists of sophisticated programs that are tied to DCU's barcoding system (each CRF is given a unique number), which allows for immediate CRF status reports that are easily accessible. This system offers full management of trial metrics during all stages of a study and for multiple studies, which makes DCU well prepared to conduct data management for several ongoing single and multicenter protocols (similar to the DCU's web-based system).

 
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