Strict protocol adherence and production of data requiring minimal monitoring time and sponsor data queries require a multi-faceted approach to quality assurance. Patient care staff undergoes rigorous training that includes inservices on specific protocol requirements, and other topics related to mental illness, psychiatric medications, side effects, and good clinical practice in research. We have unique and aggressive programs in place to train staff, to self-monitor/ audit our site, and to insure that our site produces clear data for clean CRF completion and reporting. We would be glad to discuss in detail these programs. We employ a full-time regulatory specialist, Kathleen Embry, who centrally handles all IRB issues for the study coordinators.