VCOM Institutional Policy and Procedure Manual

d. If the PI response is not received within the 14 day time period, the IRB Coordinator will contact the PI by phone or email, requesting submission of a written response. e. If after an additional seven days, the PI has not responded, an additional letter will be sent to the PI and copied to the appropriate institutional officials. 3. Level III Protocol is found to be non-compliant with HHS Regulations, in accordance with GCP, with multiple deficiencies or unacceptable degree of risk to human subjects, as is determined throughout the compliance audit review. a. The IRB Coordinator will assimilate a list of deficiencies, as identified by the IRB. b. The IRB will determine at convened meeting if the research is able to continue, in the best interest of the subjects, be temporarily suspended, or terminated. c. The PI will be notified by telephone immediately by IRB Chair Person that deficiencies were identified and the outcome of the convened meeting. d. The PI will receive a follow up letter within two business days, as to the findings of the compliance review, with a detailed description of deficiencies, as well as requirements requested for protocol compliance, and/or protocol suspension or termination. e. The PI will be required to submit a written plan of compliance to the IRB Coordinator within 5 business days, with stipulated time frames for initiation and adherence of compliance activities. f. The IRB Coordinator will distribute the plan for compliance to the IRB for further review and action. g. A hard copy of the compliance findings/responses/plans will be kept on file with VCOM IRB. h. The PI will be notified by letter, after seven days of receipt of written plan, if additional information or recommendations for revision to the plan are necessary and requested by the IRB. i. Appropriate Institutional Officials will be notified of all reviews found to be in non compliance with good clinical practice. j. Member(s) performing the initial audit review will conduct further review for compliance within six to eight weeks after formulation of a written plan of compliance, to ensure adherence. k. A follow up report will be reviewed at the next convened meeting. 7. D URATION OF P OLICY The VCOM Procedure on Reporting of Compliance Audit Review Standard Operating Procedure established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean.