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?

• Randomly − based on a list of approved studies within the IRB
• Directed − requested by the IRB or CCTST for oversight
• Investigation − resulting from an allegation or concern of noncompliance
• Educational / process improvement − investigators request ORCRA to perform an audit of their study

Regulations / Standards

21 CFR 50 Protection of Human Subjects
21 CFR 54 Financial Disclosure by Clinical Investigators
21 CFR 56 Institutional Review Boards
21 CFR 312 Investigational New Drug Application
21 CFR 812 Devices
45 CFR 46 Protection of Human Subjects (HHS)
AAHRPP
ICH 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 Practice
21 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: 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 / Standards

21 CFR 58 Good Laboratory Practice for Non-clinical Laboratory Studies