51 - Creating a Comprehensive Quality Assurance and Monitoring Program at an Academic Medical Center

Background: As an academic institution, it is important to create a dedicated, structured Quality Assurance and Monitoring program to provide monitoring services as a key part of research on human subjects to ensure conducted research is compliant with institutional policies, state and federal regulations, and best practices for protecting human subjects.

Program

Description: The Quality Assurance and Monitoring Program was started to address issues and questions brought to HRPP’s attention regarding protocol non-compliance, the need for structured guidance and staff with the required skill set and training to address/resolve such instances. This is currently done by a comprehensive review of study documentation and real-time observations of essential study procedures to ensure protocol compliance and protection of human subjects. The QAM team started by conducting routine not-for-cause (NFC) and for cause reviews, but it soon became evident, based on common findings that it was important to build a stronger QAM Program. In addition to the NFC and for-cause reviews, we have added reviews of the consenting process, internal quality reviews of the IRB and HRPP activities, study site initiation reviews (SIR’s), FDA audit support and Sponsor Investigator (SI) monitoring services for Principal Investigators who hold the IND/IDE.

Program

Assessment: The QAM program was established in 2019 for all investigator-initiated research studies, with a plan to conduct both NFC and for-cause reviews to ensure study oversight. However, the COVID pandemic severely hampered the program’s efforts in FY20-21, where all work was transitioned to remote. From FY21-22 we observed a sharp rise (391%) in the number of studies that underwent review due to both in person reviews resuming and the QAM teams growth from 2 full-time Regulatory Monitoring Analysts to 4.
The QAM team saw an increase of 24.9% based on the number of reviews per full time RMA (N=3.5) from FY22-23. Additional services were added such as SIR’s, Consent Observation Reviews, and SI monitoring services and the scope of the reviews were expanded from investigator-initiated studies to include both minimal risk and greater than minimal risk federally funded, and industry sponsored as well as reliance and sIRB studies. For FY24, we plan to include Follow-up Reviews (FUR’s) which will be performed on studies found to have significant deficiencies, upon initial review within 6 to 12 months to confirm that short-term as well as long-term corrective action plans were followed appropriately and Pre-Closeout Reviews. We also strive to enhance the focus of reviews in FY24 to ensure quality over quantity.
The QAM program created/implemented a “HRPP Quality Assurance and Monitoring Satisfaction Survey” for study teams to complete via REDCap once reviews are closed out, which has shown positive feedback thus far.

Limitations: The program's initial creation slowed down significantly due to COVID-19, the inability to conduct in person reviews and the initial apprehension of study teams upon reaching out to them to conduct reviews. However, since being able to return to campus, the increase in productivity is evident. Due to the research community's increased awareness of our program, the struggle is more with the availability of staff and time needed to handle the increasing numbers.

Discussion: There is a need to let study teams know to reach out and ask questions to Quality Assurance and Monitoring and that guidance documentation that is available to all study personnel because prevention is better than cure. We hope our program can serve as a model for other institutions to look to as they begin to develop or improve their own comprehensive research compliance programs.