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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:

Upon receipt of the above notifications and forms, the Principle Investigator is to complete the required information and return to the QA coordinator.