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S05: Benefits of Risk-Based Monitoring of Investigator-Initiated Trials (IITs) in an Academic Setting

Poster Presenter

Tali Homsey

Regulatory Manager
University of Southern California
United States

Objectives

To evaluate the benefits of risk-based monitoring of investigator-initiated trials (IITs) within an academic setting to ensure study regulatory compliance, data integrity, and good clinical practices.

Method

Monitoring visits were conducted to review regulatory and subject binders of five IITs at the University of Southern California (USC). Each IIT was assigned a risk score to determine the percentage of study documents to be reviewed during the visits. Findings from the visits were evaluated.

Results

The data collected from monitoring visits of five IITs indicate monitoring is a necessary component of a clinical trial. Monitoring ensures principal investigators (PIs) and their study team maintain complete regulatory and subject documentation, adhere to study protocol, and mitigate risks to study integrity. IITs were selected for monitoring and classified into low-, medium-, and high-risk categories based on pre-determined factors, such as the PI’s prior experience in conducting a clinical trial, trials involving a new drug, enrollment of vulnerable populations, and study design complexity. Of the five monitored studies, two were categorized as high risk, two as medium risk, and one as low risk. The risk score determined the targeted percentage of regulatory and subject documents that were monitored during the monitoring visit. For the low risk study, 10-20% of the study documents were monitored, 20-50% for the medium risk studies, and 50-100% for the high risk studies. Findings from the monitoring visits included Health Insurance Portability and Accountability Act (HIPAA) authorization form errors (two studies), informed consent form and case report form accessibility issues (three studies), incomplete subject and regulatory binders (three studies), incomplete questionnaires or worksheets (three studies), improper correction of research data forms (two studies), incomplete or missing staff training records (two studies), unable to verify source data (two studies), and IRB reporting errors (one study). Overall, the results indicate monitoring visits help to ensure regulatory compliance and data integrity.

Conclusion

IITs typically lack the monitoring support that is available to industry-sponsored trials. Currently, there is no systematic approach for monitoring IITs in the United States (U.S.); however, the number of errors found from this study’s small sample size of 5 IITs revealed that a systematic approach would be beneficial. Monitoring visits involve an in-depth review of the study regulatory binder and subject binders. Monitoring visits should take place at the start of a study, on regular intervals during the study, and when the study is completed. These visits are vital in providing essential feedback to research staff as to whether the study is being properly conducted, regulatory and data forms are correctly completed, and if there are missing or incorrectly documented information. The feedback from these visits allows the study team to make the necessary corrections and clarifications to preserve the integrity of the study and before the study findings are published and disseminated to the public. Monitoring visits also provide valuable clinical research education to research staff. For the majority of the five monitored IITs, the research coordinators (RCs) were novices to research but were responsible for maintaining the regulatory and subject binders. Since RCs may not always be aware of relevant regulations and standards, the monitoring visits help educate RCs on various regulations involved in a research study. The findings from this study indicate that monitoring visits are beneficial and necessary for ensuring study regulatory compliance, proper IRB reporting, and data integrity. Therefore, PIs and study teams of IITs would benefit from a monitoring service within their university, like those conducted for this study.