Quality assurance for interventions in clinical trials. Multicenter data monitoring, data management, and analysis.
Quality assurance for the management of multicenter clinical trials requires timely patient and data accrual and consistency with design parameters. Data from central pathology review, treatment modality, and follow-up as well as trial end points direct the selection of appropriate compliance measures. To integrate these data to monitor group performance on a specific protocol, to monitor discipline performance, or to monitor an institution's performance is a formidable task. This is especially true for a group such as the Pediatric Oncology Group, where there are a large number of protocols, many diseases, and widely differing protocol requirements. Quality assurance methods for the Pediatric Oncology Group are discussed.
Department of Pediatrics, University of Florida, Gainesville.
B H
BH
Pollock
D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection; D003627:Data Interpretation, Statistical; D005260:Female; D006751:Hospital Information Systems / Q000458:organization & administration / Q000592:standards*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards*; D011785:Quality Assurance, Health Care; D012107:Research Design