Description of Services

The Office of Regulatory Affairs (ORA) provides a broad spectrum of support for Clinical Investigators and their study teams in the conduct and navigation of clinical research regulatory requirements.

Services provided by this office include: Scientific and Feasibility Review, Data and Safety Monitoring, internal monitoring and auditing support, FDA and Sponsor inspection/audit preparation and guidance, ClinicalTrials.gov registration and results reporting assistance, FDA IND/IDE guidance and support, regulatory binder preparation, and more.

The mission of the ORA is to guide and support the UCLA clinical research community through the different compliance requirements associated with the conduct of clinical research.