Measuring Workload of Clinical Trials: Transcultural Adaptation and Validation to Portuguese Lanquage of Ontario Protocol Assessment Level (OPAL)

Abstract

Introduction: The increase number of clinical protocols with different requirements and specificities, the demand for the quality of the data according to the good clinical practices evidence the need of an instrument capable of measuring the workload of clinical protocols, and to assist the management of research centers. The object of study is the instrument entitled the Ontario Protocol Assessment Level, created for measuring the workload of the research coordinator, focusing on the complexity of clinical protocols in oncology.