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Pediatric Clinical Research Office
Quality Assurance
The purpose of the Pediatric Clinical Research Quality Assurance System within the Department of Pediatrics is to:
- Provide adequate resources for research operations to meet the research goals of the department “to be a leader in basic and clinical research”
- Be recognized for our expertise in public health care
- 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
- Meet the goals and expectations of the Department of Pediatrics Research Quality Policy
- Establish standards or performance
- Provide recommendations on improving the clinical research process within the Department of Pediatrics
Assurance of compliance is accomplished by:
- 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:
- Notification of Review Letter
- Pre-Audit Information Form
- An explanation of the Quality Assurance Review Process
Upon receipt of the above notifications and forms, the Principle Investigator is to complete the required information and return to the QA coordinator.
PCRO