Background
The Clinical Research Computing Unit (CRCU) was established on April 1, 1997 to develop research computing and data management capabilities within the Biostatistics Unit to facilitate the conduct of clinical and patient-oriented research at Penn Medicine. This new unit allowed CCEB faculty to compete successfully for Data Coordinating Centers (DCCs) of federally funded, large-scale, multi-center clinical trials and epidemiological studies. The CRCU staff and their supporting technology resources also gave CCEB faculty the ability to provide essential collaborative clinical research support for University investigators throughout the wide array of basic science and clinical departments, centers, and institutes. The new level of services from the CRCU thereby enhanced the likelihood of funding success for many research projects.
On July 1, 2002, the CRCU expanded its focus in response to overall research project growth within the CCEB and the University. The CRCU moved from within the Biostatistics Unit of the CCEB to a CCEB-wide organizational service center for both the Biostatistics and Epidemiology divisions. The CRCU now has two Faculty Co-Directors representing each of these divisions. These two Directors ensure that the overall strategy and goals of the service center are aligned with the goals of the CCEB.
Overview
CRCU personnel are directly responsible for the clinical data management systems (DMS) and research computing associated with multiple National Institutes of Health-sponsored multi-center, multi-study registry and clinical trial networks. The CRCU is fully capable of conducting studies in accordance with FDA Bioresearch Monitoring Program and International Conference on Harmonization (ICH) guidelines. The necessity for compliance with these guidelines is determined in collaboration with PIs according to the scientific goals, sponsorship, and content of the study.
