Sponsor-investigators are responsible for the selection of qualified study monitors and ensuring that trials are adequately monitored throughout the life of the trial. At UCLA, the Office of Research Administration (ORA) offers assistance with monitoring and quality assurance auditing for investigator-initiated studies. This service helps ensure compliance with FDA, GCP, and IRB regulations, as well as UCLA Health System policies and guidance as related to clinical research. The ORA monitoring program provides a proactive (rather than “for cause”) regulatory assessment and has a strong educational component.  Investigators are required to provide monitoring findings to the IRB according to their policies. The ORA auditing program includes routine and for-cause reviews (requested by institutional officials). The purpose of routine reviews is to assist investigators with achieving and maintaining regulatory compliance. The reviews are meant to be educational rather than punitive in nature. The ORA summarizes and reports the findings directly to the investigators and the CTSI DSMB.

For more information, please visit the Internal Monitoring and Auditing webpage.

Last updated
November 17, 2023