The Data Coordinating Center (DCC) serves as a centralized resource for research teams at Children’s Hospital of Philadelphia to design and conduct multicenter research. Groups that comprise the coordinating center have significant expertise and experience in conducting clinical trials, data capture, study design, data management and analyses, regulatory issues, and project coordination and management. To request help or more information, please visit the DCC request form.
The Institutional Review Board (IRB) at CHOP reviews research involving human subjects via full board review procedures, expedited review procedures, or exempt determinations. Find regulations and policies, common templates and forms, and other documents related to data coordinating centers and multisite research on their web pages.
The data management and biostatistics groups include the Biostatistics and Data Management Core, the Data Science and Biostatistics Unit, and the Pediatrics Section of the Division of Biostatistics in the Department of Biostatistics, Epidemiology, and Informatics in the Perelman School of Medicine at the University of Pennsylvania. They partner with investigators to analyze data and apply novel methodologies to complex pediatric research questions.
REDCap is the secure Research Electronic Data Capture application specifically designed to store and manage research data. Research teams use REDCap to create online surveys and capture the resulting data, and its built-in calendar tracks subjects’ research visits. They can view data within REDCap or export data in formats suitable for statistical software.
The Investigational New Drug and Device Support Program (IND/IDE) provides sponsor support services and connects sponsors to resources for successful trial execution when an Investigational Drug Application (IND) or Investigational Device Exemption (IDE) for use of a drug or device in research is required. The IND/IDE Support Office will assist with FDA submissions, study design questions, and will provide training to study teams.
The Clinical Research Support Office (CRSO) provides high quality services to assist investigators and study teams in the start-up, execution, and completion of clinical research studies. Areas of support include research staffing, clinical trials financial management, and other areas of clinical trial support.
Arcus is a suite of tools and services for CHOP’s research community that seamlessly links biological, clinical, research, and environmental data. Arcus enables collaborative research and discovery while protecting patient privacy. The Arcus team includes seasoned digital archivists, educators, analysts, and programmers who provide researchers with education, skills, secure computing environments, management of research data, and archival storage.
The Translational Informatics Group (TRiG) tackles 'deep dive' data integration projects, primarily focusing on rare disease research, that require the collection and management of data from various sources. They routinely disseminate newly developed methods to operationalize infrastructure. The team helps researchers integrate the Arcus data program into their projects. Data privacy is assured through an electronic Honest Broker.
The Clinical Reporting Unit (CRU) consists of a combination of clinical practitioners, principal investigators, clinical database specialists, and informatics programmers who deliver actionable clinical data to researchers and provide tools for efficient data management. Within the Department of Biomedical and Health Informatics, CRU faculty and staff are experts at reconciling data capture in the clinical domain with secondary use for research purposes.