Those in clinical research who most strongly believe the old saying about how “the best offense is a good defense” may often be the same people who have good reason to understand that a regulatory inspection, sponsor audit, or period of institutional review board (IRB) scrutiny could descend upon their study site at any time, announced or unannounced, so the best tactic is ongoing vigilance.
“Because of the unknowns about inspections and audits of in-progress or completed clinical trials, it is important to make sure that all study materials are always kept accurate, current, and explanative of the study activities to date,” says Ann-Marie Jacobson, CCRP, Senior Research Affairs Specialist at Tufts University School of Dental Medicine. “You always need to be asking yourself, ‘If the Food and Drug Administration (FDA), sponsor, or IRB came in right now and selected a current or recently closed study for examination, would everything be ready?’”
Her experiences with such visitations by observers who are external to research teams, but whose judgements about their work can have serious consequences for study sites, led to her recent presentation of a poster on “How to Be Your Own Internal Monitor: A Guide to Monitoring Your Own Studies” at the ACRP 2025 conference in New Orleans earlier this year.
At her institution, study coordinators “regularly conduct audits of regulatory binders, subject folders, case report forms (CRFs), payment logs, and enrollment/screening logs,” Jacobson says. “These are coordinators who are separate from the clinical team, to ensure that fresh perspectives are always present.”
Preparedness of such trial-related materials for inspections and audits needs to begin prior to study start-up, Jacobson adds, for instance by following guidance on Essential Regulatory Documents that is specific to different National Institutes of Health institutes and centers, and guidance from FDA and the International Council for Harmonization about documents used to show compliance with Good Clinical Practice and applicable regulations. One goal is to enable inspectors or auditors to see that all IRB-approved informed consent forms, CRFs, and other documents on file are complete, accurate, and the correct versions.
After an inspection or audit visit has been held, a report on how it went should be shared with the site staff and other key stakeholders, Jacobson says. “This is to notify the research team of any changes to their practices that are required, and the report should be stored in the regulatory binder,” she adds. “You’ll want to review your IRB’s requirements about what is considered reportable new information from inspections and audits, to see what needs to be shared with others in your institution and with study sponsors.”
After any changes have been made to subject files or the regulatory binder as a result of an inspection or audit, the files should be re-reviewed for accuracy and completion, Jacobson says. “You should also be thinking about your current process in terms of long-term storage of regulatory binders and subject files after study closure,” she notes. “This should be made consistent across study team personnel and protected from impacts by staff turnover.”
Site staff should keep thinking, as well, about the last time they reviewed any of the kinds of documents prepared by others that inspectors and auditors tend to focus on and ask themselves, “What would I have done differently?” Jacobson advises. “A little reflection about whether your site currently has a solid procedure in place to be ready for these visits can go a long way.”
Reported by Gary Cramer