The purpose of the IRB Research Monitoring Program is to ensure the institution’s responsibility for compliance with St. John Health System’s policies and Federal Regulations governing clinical research. The ultimate goal of the program is achieving a high quality clinical research operation. The focus of the program is ongoing monitoring of clinical research studies and the education of investigators and research staff.
The IRB Monitoring Program is responsible for and has the authority to:
- Perform routine audits on randomly selected studies that have been approved by the IRB.
- Conduct directed audits referred by the IRB, for example high-risk studies or those triggered by noncompliance (e.g. late continuing review, failure to report serious adverse events, etc.).
- Perform directed audits requested by others, such as a family member, an associate, a physician, or a study site in preparation for an external audit.
Once a study is selected for audit, the principal investigator and the study coordinator will be notified of the audit by telephone. This will be followed by a written confirmation at least 10 business days prior to the site visit. The site will be asked to submit a list of all enrolled study participants of which a minimum of 20% will be reviewed. All informed consent documents will be reviewed.
Prior to the audit, the IRB study file for the selected protocol will be reviewed, including the protocol, IRB submissions and correspondence. During the audit, all study documents will be reviewed for completeness, accuracy and compliance with regulatory requirements. At completion of the audit, an exit interview will be scheduled with the investigator and the study coordinator to review the findings. Then a written report will be drafted itemizing and describing the findings. The principal investigator will be asked to respond to this report within 30 days. The IRB will review the audit report and investigator response, and decide on the action to be taken.
If you have any questions regarding the program, please contact Denise Cunningham, R.N. at 313-343-7813 or by email at Denise.Cunningham@stjohn.org. She is available as a resource and will help you with navigating the IRB system.