CRCU Mission
The University of Pennsylvania aspires to excellence in all domains. The CRCU embraces these ideals as we partner with the faculty and their staffs to conduct superior medical research. Advances in healthcare and improvements in quality of life through research depend on thoughtful science and uncompromising integrity in data collection and handling. The CRCU excels in the support of biomedical and clinical research by providing expertise in all facets of research information management, and understanding the regulatory and cultural environments in which research is conducted. The CRCU fosters collaborative relationships with investigators in the CCEB, the School of Medicine, and throughout the University to take an active role in recognizing and meeting their research support needs. The CRCU is committed to continuous improvement in the expertise and services that we offer by emphasizing education and training for staff and employing leading technologies and creative solutions.Core Services of the CRCU
The CRCU provides a complete set of services to facilitate the collection, storage and management of clinical research data for any size research study conducted by University investigators and their collaborators. Whether the CRCU performs the myriad duties of a Data Coordinating Center for multi-center research networks or creates a simple database to organize cohort data, each project receives the right amount of specialized expertise and attention to ensure successful completion with accurate and reliable research data.Project Operations & Compliance:
- Cross functional coordination and training on applicable guidelines and regulations
- Project start-up regulatory consultation
- Project time line definition and management
- Research Network Development
- Identify Collaborating Members
- Establish Communication Protocols
- Coordinate Collaboration Activities
- Facilitate Results Dissemination
- Site Management
- Develop Regulatory Documentation
- Facilitate Protocol Training
- Filing and maintenance of investigator-initiated INDs/IDEs
- Informed consent review for compliance with ICH and HIPAA requirements
- Safety reporting to regulatory authorities (U.S. and international)
Clinical Data Management:
- Study Design and Development
- Study Protocol: Translation of these Materials into a Data Management Plan (DMP)
- Development of Case Report Forms (CRFs) and the Data Collection Process
- Study Management, Data Collection and Processing, and Record Keeping
- Development of Data Processing Procedures
- Specification of Source Materials and Data for the Project Data Management System (DMS)
- Development, Testing, and Validation of the Project DMS
- Data Management System Use for Data Entry and Processing
- Data Quality Control, Assurance, Monitoring, and Reporting
- Study Related Personnel Training
- Study, Site Quality and Protocol Compliance Monitoring
- Data Reporting
- Online edit checks - occur at time of data entry
- Data Validation-programmatic application of data rules run against data
- Data that violates rules initiate queries to clinical research staff to clarify, modify, or confirm with study subjects
- Clinical staff may submit change request for erroneous data
Research Technologies:
- 21 CFR Part 11 Compliant Software
- Complete Data Management Tools
- Patient Recruitment Tracking
- Data Entry (Double & Single)
- Programmatic Data Validation
- Data Editing & Electronic Audit Trails
- Electronic Data Importing
- Reporting
- Custom database application development
- Oracle Pharmaceutical Applications
- Oracle Clinical
- Remote Data Capture
- Expert application support
- Firewall protection and secure data storage
- User account administration
- Database monitoring and administration
Biomedical Research Computing:
- Unix, Solaris, Linux, Windows OS Administration
- Network and computing systems architects
- Professionally managed data center
- 100+ servers/devices
- 150+ network connections
- 55 2Gb-fibre channel high speed storage connections
- Unix, Solaris, Linux, Windows OS
- Oracle Databases
- 16+TB storage
- Business continuity planning
These core services allow the CRCU to participate in various research programs within the University, as well as with external research-related entities.
The CRCU serves as a "Core Research Facility" within the University to allow researchers and investigators access to its services across a wide range of research programs and medical disciplines.
