Center for Clinical and Translational Science

Every investigator’s pulse inevitably quickens at the prospect of an audit, yet for those investigators who have completed audits with any of the Clinical Research Support Office’s (CRSO) three auditors and implemented a Corrective Plan of Action, it is clear that the goals of the program are educational and non-punitive, aiming to make sure that coordinators and investigators have the skills, tools, and knowledge they need to accurately and safely conduct their protocols. The CRSO audit program is an initiative of the University’s NIH-supported Clinical and Translational Science Award (CTSA). The audits are conducted according to written Standard Operating Procedures (SOPs), and based on the applicable regulations and practices of the National Institutes of Health (NIH), Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), Good Clinical Practice (GCP), and the Rockefeller Institutional Review Board (IRB). Audits follow a standard set of practices that are specified in the SOPs and outlined in the audit notification letter sent to the Principal Investigator (PI).
Most audits are selected randomly, prioritized so as to insure that the protocols with greatest risk to human subjects receive the highest priority. The experience of the PI is another factor considered in prioritizing audits. Routine audits are considered "not for cause" meaning that they are conducted as part of quality assurance of our research program and not due to any specific concern. The results of "not for cause" audits are not routinely reported to the IRB, but may be reported if the audit findings merit IRB review in the opinion of the Clinical Research Officer. Most protocol deviations identified during audits are addressed rapidly by correction action plans are thus do not need to be reported to the IRB. “For Cause” audits are also conducted, and may be requested by the IRB or the PI, or prompted by a concern brought to the attention of the Clinical Research Officer, such as irregularities in the informed consent forms, research or medical records, or concerns voiced by staff. “For Cause" audits are reported to the IRB Chair for review. The CRSO does not report its audits to OHRP, the FDA, or other entities. Such reporting actions occur only through the SOPs and mechanisms of the IRB. Data obtained by CRSO audits are used to guide the Center’s educational programs for the entire staff, insuring that everyone benefits from the information obtained.

The CRSO has conducted 36 audits since the inception of the program. Of the 27 investigators and coordinators filling out post-audit satisfaction surveys, 85% of respondents expressed either positive or highly positive comments about the program. Investigators who attend the educational training programs sponsored by CRSO have fewer findings during their audits, indicating the value of these programs. These seminars review standards for study conduct and provide an explanation of the audit process. The CRSO and audit staff are available to answer questions about study conduct or audits at any time.

When a protocol is chosen for an audit, the Auditor contacts the investigator and study coordinator to notify them of the upcoming review, set the date, and answer any questions. Investigators with pending grant deadlines, travel, or other time constraints can work with the Auditor to identify a time that is mutually convenient. Once a time has been agreed to by both parties, the Auditor will send a formal notification letter detailing the dates of the audit and the documents to be reviewed.

Throughout the audit the Auditor will discuss any problems or questions that arise with the investigator and research team. Investigators are given the opportunity to resolve issues and locate missing documents before the audit report is written. The investigator may work with the Auditor to make corrections to documents and reports to the IRB, and to make changes in workflow that are necessary to bring study conduct into compliance with GCP.

A report detailing the issues identified during the audit is drafted, and reviewed by the Clinical Research Officer before being sent to the investigator. Typically the report cites the relevant regulations and guidelines, along with recommendations for a Corrective Action Plan. The research team implements and documents the completed corrections before an Audit Closure Report is finalized. Occasionally the Corrective Action Plan calls for a specific training session for the research team (usually provided by the CRSO staff) or additional auditing or monitoring after a short interval to be sure the team has mastered the necessary tools to move forward successfully. 

In our next installment: Common Audit Findings at Rockefeller University, Frequently Asked Questions, and "Is Your Research Audit-Ready?”