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      Statement of Compliance

      Covenant Health Institutional Review Board (IRB)

      FWA00003297 (exp date: 07/22/2011)

      The above mentioned is a duly constituted Institutional Review Board and is organized and operates according to applicable laws and regulations. The CHS IRB has written procedures for initial and continuing review of clinical trials, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process, in compliance with 45 CFR 46, 21 CFR Parts 50 and 56 (Code of Federal Regulations), ICH (International Conference on Harmonization) guidelines and GCP (Good Clinical Practice).

      Respectfully,
      Becky Roberts, MS, CIP
      CHS IRB Administrator

      © 2009 Covenant Health
      100 Fort Sanders West Blvd.
      Knoxville, TN 37922
      (865) 374-1000