CPMC IRB Compliance Statement
IRB Compliance Assurance
The California Pacific Medical Center (CPMC) Institutional Review Boards (IRB) are duly constituted, have written procedures for initial and continuing review of clinical trials; prepare written minutes of convened meetings, and retain records pertaining to the review and approval process; all in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56; HHS regulations 45 CFR 46, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable.
The CPMC IRBs are registered with OHRP/FDA. Our Federalwide Assurance number is FWA00000921. The registration number for CPMC IRB#1 is IRB00000239; the registration number for CPMC IRB#2 is IRB00005842. CPMC’s parent organization number is IORG00000141 (effective through January 12, 2013).
CPMC IRBs also review in compliance with other applicable federal and state laws and regulations governing IRBs and research with human beings.
If you have any questions or need further information, please do not hesitate to contact us.
Back to top