Computer Systems: Data Management Group Services
Research Data System
Research Data System (diagram) for multi-center studies is a customized hybrid of off-the-shelf software that combines decentralized data submission, centralized and remote data editing, and a centralized database structure designed to collect, transfer, and store data for epidemiologic studies.
The system integrates scannable forms with Internet capabilities to provide rapid and timely access to highly accurate and clean data. In this system, data are collected and transmitted to the DMG by remote clinical sites. After the data have been electronically received by the DMG, they are assessed for quality via automated and manual processes and then written to the study database. Every hour, queries (data discrepancies) are generated to identify potential errors in the study data. These queries are accessible via a secure study web site so that clinic staff can immediately resolve them in a timely manner. When appropriate, sites can audit data in real-time via the web site, which automatically generates a full audit trail. Data from outside sources such as reading centers data or core lab data are integrated into the study database.
The standard system includes a limited access study web site for administrative coordination and data operations. The typical study web site will have 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 query generation and resolution
- Real-time audit trail
- Comprehensive reports for effective study management
- Web-based support for the publications process
- Compatibility with SAS for ease of data analysis
Key Benefits:
- Eliminates delays in identifying missing data
- Eliminates delays in cleaning data - Real-time reports enable more efficient workflow
- Allows monitoring of study progress in real-time
- Reduces costs
- Rapid database lock
Main System Components:
- Teleform - commercial software for creating machine-readable data collection forms that can be scanned for faxed directly into the database
- StudyWeb (also called Keeptrack) - web-based study-management tool for clinics
- MAdmin - administrative website for managing StudyWeb
- Qsyst - website for creating and maintaining the Data Dictionary, format, and custom logic checks
- MIFWeb - An optional site used for tracking an adjudicating medications
- StudyOnline - An optional site that provides a public web interface to a study's data and documentation (version 4 only)
Security Features:
- Network firewall
- 128-bit encryption
- Daily back-up with twice monthly off-site storage
- User ID/password authentication
- Data access restricted by site (i.e., sites can only view their data)
- Data audit trail
- Meta-data audit trail
Implementation Standards:
| Typical time to database release to sites once data collection forms have been designed | 3.5 months (more if additional features are added to the system) |
| Site requirements |
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| Coordinating center support roles (one person may fulfill multiple roles) |
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| User training |
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Additional information on RDS is available to SFCC and WHCRC users on the InsideCC website. For pre-award assistance, contact Cary Fox.