Zenith Rosa Silvino
Brazil
Research Article
Measuring Workload of Clinical Trials: Transcultural Adaptation and Validation to Portuguese Language of Ontario Protocol Assessment Level (OPAL)
Author(s): Roberta Monteiro Batista Sarmento and Zenith Rosa SilvinoRoberta Monteiro Batista Sarmento and Zenith Rosa Silvino
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.
Aim: To perform a transcultural adaptation and validation of the instrument in terms of the Portuguese language.
Method: This is a methodological research, whose chosen scenario was the clinical research center of the Brazilian National Cancer Institute, located in Rio de Janeiro. The subjects .. View More»
DOI:
10.4172/2155-9627.1000308