VCOM Institutional Policy and Procedure Manual

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A5 Effective Date: November 1, 2007

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ Addendum to VCOM IRB Policy No. R004 VCOM Policy on Compliance Auditing ____________________________________________________________________________________ P URPOSE OF A UDIT The purpose of Institutional Review Board (IRB) auditing is to provide guidance to investigators to help ensure compliance with VCOM IRB and federal policies as well as to assist investigators with self monitoring to assure the protection of human subjects in VCOM IRB approved research studies. The components herein are part of the routine compliance audit conducted by VCOM. There may be additional requirements depending on the approved study stipulations. D EFINITION Audit: A proactive and systematic inspection of a research protocol to include related activities and documents to determine whether the research study has been conducted, the data recorded and accurately reported, according to the protocol specifications and applicable regulatory requirements. G OALS OF A UDIT The following goals of auditing are in accordance with and under the authority of section 45 CFR 46.103(a) of the HHS regulations which states that each institution engaged in non-exempt human subjects research must comply with HHS requirements, as designated in Office of Human Research Protections (OHRP) Federalwide Assurance. An assurance approved by OHRP commits the institution’s designated IRB and research investigators to full compliance with the HHS regulations. 1. Audits will provide a mechanism of procedure for VCOM IRB to monitor compliance with human subject protection requirements. 2. Audit procedure will serve to ensure protocol or study compliance with VCOM IRB policy, the International Conference on Harmonisation (ICH) Good Clinical Practice, the Food and Drug Administration (FDA), and the Department of Health and Human Services (DHHS) OHRP Regulations and Guidelines to ensure subject safety and improve the quality of human subject research protections. 1. 2. 3.