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    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, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) E6, as applicable. CPMC IRBs also conduct reviews in compliance with other applicable federal and state laws and regulations governing IRBs and research with human beings.

    The CPMC IRBs are registered with OHRP/FDA, CPMC’s parent organization number is IORG0000141. Our Federalwide Assurance number is FWA00000921. The registration number for CPMC IRB#1 is IRB00000239; the registration number for CPMC IRB#2 is IRB00005842.

    If you have any questions or need further information, please do not hesitate to contact us.

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