QOL DATA COLLECTION Clause Samples

QOL DATA COLLECTION. QLQ-C30 questionnaires must be filled out at the hospital when the patients comes to the hospital for a scheduled visit. The questionnaire will be handed out to the patients by the investigator or a study nurse prior to seeing the doctor for clinical evaluations. Patients will be asked to fill out the questionnaires as completely and accurately as possible. The average time to complete the entire questionnaire is approximately 10-15 minutes. The compliance of the QoL assessments will be reviewed twice a year and will be a part of the descriptive report by Data Center for the Group's plenary sessions. Mastercopies of the QoL questionnaires (EORTC QLQ-C30, the QLQ-LC13, and the EORTC Health Thermometer) will be sent to the institution together with CRF's. The clinical forms will include a question whether the QoL forms have been filled in -and if not, the reason why. Guidelines for the administration of QLQ-C30 and QLQ-LC13 questionnaires are added in Appendix III. 42/102 60 [LOGO] The SILV▇ ▇▇▇dy --------------------------------------------------------------------------------