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The mission of the Research Compliance Program (RCP) at Cincinnati Children’s Hospital Medical Center is:
The RCP achieves this mission primarily through supporting the other program areas within ORCRA by providing the necessary and independent internal compliance auditing and investigation functions. The RCP also collaborates closely with ORCRA’s Research Education Program to identify and facilitate many of the institution’s research-related education and training needs.
The Research Compliance Program consists of auditing and QA oversight for the following functional areas:
Audits are performed on studies of research involving human participants. Audits serve two primary functions: (1) to provide support to investigators in the process of research and (2) to identify difficulties with the conduct of research at the earliest possible moment to proactively institute individual and system level changes to ensure that all human subjects research is conducted to the highest ethical standards and in compliance with all applicable federal, state and institutional requirements.
How are studies chosen for audit?
Regulations / Standards
21 CFR 50 Protection of Human Subjects21 CFR 54 Financial Disclosure by Clinical Investigators21 CFR 56 Institutional Review Boards21 CFR 312 Investigational New Drug Application21 CFR 812 Devices45 CFR 46 Protection of Human Subjects (HHS)AAHRPPICH E6: Good Clinical Practices
Quality assurance oversight is provided for the areas of Cincinnati Children’s that are obligated to comply with these regulations including the Cancer and Blood Diseases Institute’s Translational Core laboratories: Cellular Manipulations Laboratory (CML), Vector Production Facility (VPF) and Translational Trials Development and Support Laboratory (TTDSL).
Regulations / Standards
21 CFR 210 and 211 Good Manufacturing Practice21 CFR 1270 and 1271 Good Tissue Practice
Quality oversight is provided for the areas of Cincinnati Children’s that are subject to these additional standards, including the following three laboratories at the Oak Campus: Laboratory for Specialized Clinical Studies (Division of Infectious Diseases), Central Laboratory (Division of Pathology and Laboratory Medicine) and Laboratory for Applied Pharmacokinetics and Therapeutic Drug Management (LAPTDM).
Regulations / Standards21 CFR 58 Good Laboratory Practice for Non-clinical Laboratory Studies
For additional information regarding the Cincinnati Children’s Research Compliance Program, including consultation regarding compliance planning or determining how to handle / manage compliance concerns, contact the ORCRA and ask to speak with the research compliance program director.
The Office of Research Compliance and Regulatory Affairs provides training programs, seminars and events that improve compliance with federal regulations and institutional policies governing research, while promoting research integrity and best practices for research professionals.
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