Data management
The eCRF will gather both clinical data and quality of life questionnaire (EQ-5D, Voice Handicap Index, SWAL-QOL, SF 36, and STAI) data.Data collected will be managed in the Biostatistics and Epidemiology unit at Gustave Roussy.The data collected through the eCRF will be the source data for the analysis. All the statistical analyses will be performed at the Biostatistics and Epidemiology Unit of Gustave Roussy. Therefore, no data transfer will be needed.In order to guarantee the authenticity and the credibility of the data in conformity with good clinical practices, the Sponsor has installed a quality assurance system which includes:Trial management in accordance with the procedures at Gustave Roussy,Quality control of data at the investigating site by the Clinical Research Assistant (CRA) in accordance with the monitoring plan,Possible auditing of investigating centres.