Quality Assurance
The purpose of the Pediatric Clinical Research Quality Assurance System within the Department of Pediatrics is to:
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Provide adequate resources for research operations to meet the research goals of the department “to be a leader in basic and clinical research”
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Be recognized for our expertise in public health care
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Assure that clinical research is in compliance with FDA, DHHS domestic regulations, Clinical Practice Guidelines (GCP), Research Clinical Billing Standards and local and federal human subjects standards
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Meet the goals and expectations of the Department of Pediatrics Research Quality Policy
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Establish standards or performance
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Provide recommendations on improving the clinical research process within the Department of Pediatrics
Assurance of compliance is accomplished by:
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Providing routine Clinical Study Quality Assurance Reviews (audits) and Research Clinical Billing Reviews that consist of an in-depth analyses of review findings covering a variety of areas associated with standards of performance and mandated regulations
When a principal investigator is notified of a Clinical Study Quality Assurance Review, the investigator will receive:
Upon receipt of the above notifications and forms, the Principle Investigator is to complete the required information and return to the QA coordinator.