The Clinical Research Computing Unit (CRCU) is an Academic Clinical Research Organization within the Center for Clinical Epidemiology and Biostatistics (CCEB) in the Perelman School of Medicine at the University of Pennsylvania. Since its inception in 1997, the CRCU has been expertly providing the full range of services essential for the conduct of clinical research projects, including Phase I-IV, multi-center, randomized, clinical trials, registry, and cohort studies utilizing state-of-the-art technology and tools to ensure superior data quality. The CRCU provides expertise in project management, data coordination and research computing tailored to meet your project requirements. The CRCU project teams partner with the BAC in the project design phase to plan accurate and precise data collection modules and to structure project reports for steady oversight. We specialize in study design and development, site management and training, data collection, processing, quality control, regulatory requirements and reporting, database development, administration, security, data storage and proposal development.
Speiser, Florence, M.S.
Role: Manager, Project Proposals and Accounts, 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."
A vast variety of databases and specialized database modules are developed to support a vast variety of projects ranging from simple cohort studies and registries to extremely complex multi-site Clinical Research Networks that require Data Coordinating Centers (U01, U10) to conduct multiple concurrent clinical trials.
In many cases, several products like REDCap, Oracle, and Oracle Clinical are all used on one complex project to perform multiple functions required to support the project.
All databases and special database modules (subject tracking,
screening, eligibility, and randomization, data discrepancy resolution, data validation, validation rule violation resolution) are used to support all activities of all Units within the CRCU and the studies that CRCU is supporting.
* 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)
Services include consultation on design and informatics and data coordination strategies for research proposals and pilot studies. Services are often provided by CRCU members from the divisions of Research Technologies, Clinical Data Management, Project Management, Operations and Compliance, and Biomedical Research Computing, who have expertise across a wide range of technologies and extensive experience working with biomedical and clinical investigators in diverse disciplines. This expertise and experience includes development and implementation of studies of all sizes from small pilot studies to large-scale, multicenter clinical trials, collaborative clinical and patient-oriented research, and multi-institutional health services research projects.
"The CRCU has extensive experience providing design, development and project and technology support services to the entire Penn Medicine clinical and translational research enterprise."
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