OBJECTIVES: eVOBS is an international, non-interventional, observational study of clinical and economic outcomes in patients who receive VELCADE for the approved indication in multiple myeloma. METHODS: Patients who initiate VELCADE therapy for the approved indication are eligible for the study. Retrospective treatment data from 12 months prior to study entry and prospective treatment data for 36 months are collected via a secure, privacy-protected website. At study entry, submitted data are electronically screened against validation rules that have been prospectively established in consultation with multiple myeloma treatment specialists and data analysis specialists. These rules were designed to prevent missing data, duplicate data and data outside pre-established, logical ranges. Initial inputs require study center confirmation before the system uploads data to the central database. During the study, if there is any data that is inconsistent with previously submitted entries, study sites submit corrections via an audited online data change request system. Finally, an ongoing audit process is used to validate the quality of the data uploaded to the central database. This process uses monthly reports to identify potential inconsistencies within the dataset after data has been validated at entry. RESULTS: Uploaded data undergoes quality control checks, requiring adjustment by physicians to be minimal. Audit reports help to redress data entry training issues, further enhancing data accuracy. Analysis is only conducted on patients after resolution of outstanding supplemental data queries. CONCLUSION: The goal of this study is document outcomes in a generalizable, representative patient cohort. This information will broaden our understanding of the use of VELCADE in typical clinical practice, outside of the interventional clinical trial setting. This largely automated three-stage quality control process streamlines the implementation of this non-interventional, observational research and permits the inclusion of patients from a broad geographic region. The study method allows for faster analysis and presentation of robust, pragmatic outcomes data.