Research Compliance Assessment
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About Audits
§ Types of Audits
The types of audits we do depend on the source of the request for the audit. Directed Audits are those that are requested to be done by an internal or external committee or individual. Requests may come from the Vice Provost for Research, the IRB, or other committees within the University. Additionally, audits requested by regulatory agencies such as OHRP, would also be done by our group. Routine audits are of those studies that are selected for audit by pre-determined criteria based on assessment of regulatory risk. Some examples of those criteria are funding source, number or type of studies being done by any one investigator, and studies involving vulnerable populations.
§ What to Expect
Research standards used in the audit process are the federal rules and regulations governing human subject research, the Code of Federal Regulations 45CFR and 21CFR, state regulations and University policies and procedures. The Research Compliance Officer assigned to conduct the audit will contact the Principal Investigator and arrange a time for the audit. At the beginning of the audit, an initial meeting with the Principal Investigator, sub-PI and/or Study Coordinator will be held to review the audit schedule, procedures and plan. The audit consists of a review of all documentation pertinent to the study. All informed consents will be reviewed. A selection of subject records will be reviewed as well as study documents and correspondence. A tour of the facility may be performed, and/or interviews may be conducted with the research staff and any other procedures necessary to understand the conduct of the study. At the conclusion of the audit, a closeout meeting or exit interview will be held to discuss audit findings and answer any questions. The audit report will then be prepared by the Research Compliance Officer, issued to the Principal Investigator and the Chair of the Department, the report, and any response received, is forwarded to the HSRO and the Office of Research.
§ How to Prepare
Once the Research Compliance Officer selects a protocol for review, the Principal Investigator will be notified. The Principal Investigator and/or study staff should then gather all study related material, request medical records for enrolled subjects as well as review and organize study material. It is helpful to have study records will organized. However, the investigator or the study staff should not attempt to create or correct records prior to the audit.
§ How to Respond
When the audit report is issued the findings will be categorized as having a High, Medium or Low significance.
High: A finding considered by the Office of Research Compliance Assessment to:
Medium: A finding which is a deviation and/or deficiency in compliance with any appropriate regulations and guidelines, the protocol, and/or university policies, or a finding that may call into question the integrity of the data.
Low: A finding which does not indicate a breakdown or deficiency in compliance, but may, if not given attention, lead to a breakdown or deficiency. Any action taken should lead to an improvement in the quality of systems in place.
All findings of High or Medium significance require responses. You may respond to findings of Low significance, but it is not required. Responses should include the following:
Please submit your response directly to the RCA auditor, preferably electronically. If a response is not received within one week from the time the report is issued, the report will be forwarded to the Human Subjects Research Office (HSRO). You may then submit your response to the HSRO or they will contact you for follow-up. If your response to the findings is incomplete and/or unsatisfactory, you will be contacted by the HSRO.
§ Common Findings
Major audit findings have been related to informed consent, documentation, IRB related issues and protocol compliance.
Informed Consent:
Documentation:
IRB-related Issues:
Protocol Compliance:
