May 2025

A single protocol, or any protocols currently being conducted by an investigator may be selected for a “directed audit” (also referred to as a “For Cause” audit) by any of the JHM IRBs that oversees the protocol(s), the Vice Dean for Clinical Investigation, or by referral from other entities across the Johns Hopkins Medicine Human Research Protection Program (HRPP). These audits may be conducted for a variety of reasons, ranging from repeated incidence of non-compliance to complaints received from participants or JHU employees. Depending on the impetus for the audit, all regulatory and subject records are subject to review. Occasionally, the audit may require confidential interviews with the principal investigator, study personnel, or complainants. If the scope of the audit is broad, designated members of the Compliance Monitoring Program (CMP) team will be assigned to lead and conduct the audit. Most audits involve remote reviews of relevant study documentation and materials, with meetings with the PI and others accomplished via Zoom or MS-Teams.

Before the Audit:

When the JHM IRB directs an audit, the Principal Investigator (PI) will be notified by the IRB via eIRB. At this time, the CMP Director and Associate Director will also be contacted, who will develop an audit plan to be approved by the Vice Dean for Clinical Investigation and Associate Dean, Human Subjects Protection. The CMP representative (or “lead auditor”) will contact the PI by email to inform the PI of the audit process and what research materials will be needed. In preparation for an audit, study teams should review their regulatory information (IRB, FDA documentation, if applicable, SOPs, etc.), and ensure that all study information is complete and available.in a logical order. Research participants materials, as requested, should also be made accessible to the CMP representative as requested.

As part of the notification to the PI, the CMP auditor will formally request the relevant documentation be forwarded electronically to the CMP auditor via a secure file share system. Based on the nature of the directed audit, requested documentation may include signed consent forms for each enrolled subject; documentation of eligibility, along with source documentation to verify eligibility and for verification of the completion of protocol procedures; participants’ research data (e.g., case report forms); and logs of all adverse events and protocol deviations.

During the Audit (the Records Review (and interviews, if applicable):

The CMP auditor will review the received requested materials to check for information related to the issue(s) or event(s) that precipitated the directed audit. The PI and/or a designee from the study team should be available (by email or telephone) in the event the CMP auditor has any questions or needs additional information. If interviews are part of the audit, the CMP auditor and selected individual(s) from the study-team will meet via Zoom or MS-Teams. This discussion will remain confidential, with the CMP auditor compiling all responses to be entered into the audit report.

After the Audit (the Audit Report):

Following the audit, the CMP auditor will write up a report. The report will contain a summary or background of the directed audit, along with a detailed account of the auditor’s findings. The findings, where necessary, will include follow-up corrective actions. This report will be sent to the Vice Dean for Clinical Investigation and the Associate Dean for Human Research Protections for review. Where indicated, the finalized report will be sent to the chair of JHM IRB of Record for their review or may be referred to the Executive IRB for review. The CMP auditor will communicate any immediate required corrective action(s) noted in the report (e.g. if prompt reporting to the IRB of an identified issue is required). The reviewing IRB may issue other additional corrective actions, where applicable which may include additional retraining by the CMP team.   

 

Please contact any member of the Compliance Monitoring Program with any questions or to receive more information: https://www.hopkinsmedicine.org/institutional-review-board/about/compliance-monitoring/contact