VCOM Institutional Policy and Procedure Manual

Edward Via Virginia College of Osteopathic Medicine

Effective Date: October 15, 2009

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

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ VCOM Procedure on Reporting of Compliance Audit Review Standard Operating Procedure ____________________________________________________________________________________ 1. P URPOSE The purpose of the Reporting of Compliance Audit Reviews Standard Operating Procedure is to describe the process to be followed by the VCOM IRB to disseminate the findings and define the outcome(s) of the compliance audit reviews performed by the IRB, in accordance with VCOM policy on compliance auditing, during the post approval monitoring (PAM) period(s). 2. S COPE This Standard Operating Procedure (SOP) applies to all Compliance Audit Reviews performed by designated VCOM IRBR member(s). 3. R ESPONSIBILITY The IRB Chair Person, and in the absence of Chair Person, the Co-Chair Person will present the results of the compliance audit review to the IRB. The IRB will review the report(s) and decide upon one of the following levels of outcome and necessary action to be taken. This SOP must be reviewed annually by the Associate Vice President for Research. REGULATIONS To ensure the compliance with human subject protections requirements, PAM will be in accordance with and under the authority of 45 CFR 46.103 of the HHS regulations which states that each institution engaged in non-exempt human subjects research must comply with HHS requirements, as designated by the Office of Human Research Protections (OHRP) Federalwide Assurance. 4.

5.

DEFINITIONS Keywords as defined by ICH E6

Good Clinical Practice : A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported