Regulatory Knowledge and Support Program (RKS)
CTSI Office of Regulatory Affairs
The Office of Regulatory Affairs (ORA) can assist with:
- Data and Safety Monitoring Board (DSMB)
- Internal monitoring and auditing
- Preparation for an FDA or sponsor inspection
- Guidance on clinicaltrials.gov registration and results reporting
- Scientific review
See complete details on the ORA services page on CTSI ResearchGo.
Contact: CTSI Office of Regulatory Affairs at ctsiora@mednet.ucla.edu
