VCOM Institutional Policy and Procedure Manual

3. Investigators and research team(s) will use VCOM audit review form as an educational tool to assure compliance with ICH Good Clinical Practice Guidelines as well as regulatory and ethical responsibilities. 4. The IRB will use the audit review tool as a quality control function to proactively oversee approved research studies and to educate investigators and increase awareness of any problem areas, and to take corrective action as necessary to assure the protection of human research subjects. P ROCEDURE The audit procedure and guidelines are described below: 1. The type of audits conducted will be random with protocol selection being conducted by the IRB Chairman, with the assistance of the IRB Coordinator, from a list of all actively approved protocols. 2. Each IRB member will be asked, but not required, to complete one audit review per year in anticipation of VCOM IRB conducting 10-20 audits per year. 3. The IRB Coordinator will contact the Principal Investigator (PI) two to three weeks in advance via email or telephone to schedule the audit. At that time the audit review form will be electronically sent to the PI and/or research coordinator to ensure that the appropriate documentation is available for review. 4. A follow up email will be sent to the PI or research coordinator which will confirm the audit notice, and detail the logistics of the meeting date, time, and place. 5. Approximately 7-10 days prior to the scheduled audit, the PI and/or research coordinator will provide a list of enrolled subjects as well as their date of enrollment, ensuring confidentiality of subjects by using a unique identifying number, to the IRB Coordinator. 6. Research study subjects’ records to be audited will be randomly selected by the IRB Chairman and assigned to a designated IRB member. Depending on enrollment size, 5% of subjects will be selected for audit, or if subject population is small, all may be audited. The auditor may choose to add additional selections on-site if warranted. 7. The IRB Coordinator will inform the PI of the subjects to be audited 24-48 hours prior to audit so that research records involved will be available for review. 8. Research team members may or may not be present during the audit review but must be available for any questions that the auditor may have. The PI will interview with the auditor prior to conclusion of the audit to answer any questions or respond to any recommendations or findings that may have arisen during the audit. 9. The auditor must have access to any of the research subjects’ medical records, case report forms or any associated documents, as sited in the audit review form. 10. The auditor will complete the audit review form(s) and submit to IRB Chairman or IRB Coordinator within 3 -5 days of the scheduled audit, and the auditor will also immediately report any activity that would create cause for concern to subject safety. 11. Audit reviews will be reviewed by the IRB Chairman and a complete final audit report will be prepared and sent to the PI within two weeks following the audit. 12. The IRB chairman will present the final audit report to the Board for information and necessary action. 4.