The Research Data and Technology Group is a small, agile and fully certified team of programmers and network administration personnel who excel in developing and implementing innovative database and technology solutions with a fast turnaround. We have expertise in data capture, integration, and conversion; study management; tracking databases, public data releases; and web-based applications. Coordinating Center computer systems are hosted on a high-speed, secure network that includes two dedicated data centers, 24/7 network monitoring, and back-up redundancy. Our systems are implemented following a 21 CFR-compliant validation process.
Research Data System©
RDS© is the data collection and study management system used by our multi-center studies and clinical trials. RDS© uses TeleForm® for data collection form design, with a web-based front end and SQL back-end for data tracking, querying, editing, reporting, and study administration.
RDS© integrates scannable forms with Internet capabilities to provide rapid and timely access to highly accurate and clean data. Data are collected and transmitted to the Coordinating Center's network by remote clinical sites. Once received, the data is checked for quality via automated and manual processes. Queries run hourly to check for data discrepancies, which are posted on a secure study website so that clinic staff can resolve them. Designated site staff can change data in real time with all changes being captured in an audit trail. Data from outside sources such as reading centers or core labs can be integrated into the study database.
The standard system includes a study website for administrative coordinating and data operations. The typical study website has several distinct components: administrative (meeting planner, document archives), data system support (user manuals, Q&A), forms tracking, querying and editing reports, and other types of reporting (recruitment, retention, editing).
Key Features:- Variety of input options (fax, scan, web entry)
- Powerful and flexible data dictionary and subsequent ongoing query generation
- Real-time access to study data
- Real-time audit trail and meta-data audit trail
- Comprehensive reports for effective study management
- Web-based support for the publications process
- Compatibility with SAS for ease of data analysis
- Fast, reliable, and secure network
- Flexible and rapid start-up – 3 months, once data collection forms have been designed and approved
- Universal, low-tech requirements make it easy for sites to implement – one or more PCs equipped with recent version of an internet browser and a fax machine or scanner
- User training and documentation provided
- Eliminates delays in identifying and resolving data issues – real-time reports enable more efficient workflow
- Allows monitoring of study progress in real-time
- Reduces costs
- Rapid database lock
Medical Inventory Forms©
MIF interfaces with RDS© and allows studies to track and adjudicate medications.
Adjudication Tracking System©
Adjudication tracking databases are used for outcome ascertainment studies. Studies can assign adjudicators and track, bill, and monitor adjudication events. If desired, databases can interface with RDS© to share data and initiate event adjudication in real time.
For additional information about data systems services available including cost estimates please fill out this online form, or contact [email protected] for more information.