12 - Leveraging Qualtrics for Post-Approval Monitoring: A Practical Approach for Small IRB and IACUC Offices with Future Automation Potential

Background: : Post-approval monitoring (PAM) is critical for regulatory compliance, yet small IRB and IACUC offices without electronic submission platforms struggle with systematic oversight. At the authors University, PAM previously relied on Excel and email check-ins. To improve monitoring, the University integrated Qualtrics to standardize investigator engagement and data collection.

Program

Description: : At the University, no electronic IRB or IACUC submission platform exists, making compliance tracking manual and resource intensive. In collaboration with the Academic Technology Advisory Committee, the Office of Research Integrity integrated Qualtrics to:

1. Standardize investigator check-ins: Using Qualtrics surveys to collect structured responses on protocol progress, deviations, and adherence. This approach streamlines administrative study closures, eliminating the need for investigators to submit separate closure forms. This pathway is utilized for exempt research and expedited studies without assigned expiration dates on the IRB side, and for yearly reporting and study closures on the IACUC side.
2. Capture & analyze metrics: Extracting survey data to identify trends and compliance risks.
3. Hybrid tracking system: While Qualtrics facilitates compliance data collection, protocol expiration dates and annual reports are still manually tracked in Excel.

Although not fully automated, this model improves oversight in a small office lacking a dedicated IRB/IACUC submission system.

Program

Assessment: : Implementing a Qualtrics-based PAM model at the institution demonstrated several qualitative improvements over prior informal methods:

• Greater investigator engagement: Structured Qualtrics check-ins led to more consistent responses compared to previous passive email follow-ups, leading to improved communication and accountability.
• Improved issue identification: The survey-based approach standardizes reporting, allowing for earlier detection of compliance concerns, reducing the risk of protocol deviations, and enhancing regulatory adherence.
• More organized data collection: Qualtrics centralizes responses, facilitating trend analysis, despite continued manual tracking for submission deadlines.

However, implementation was not without challenges:
• Institutional access & training: Obtaining Qualtrics access required institutional coordination and approvals. Additional training was needed to familiarize admins with the system.
• Investigator adjustment: Some researchers were unfamiliar with structured PAM surveys, requiring outreach and training.
• Manual reporting still needed: Because the University lacks an electronic IRB/IACUC system, key deadlines still require Excel tracking.

Despite these challenges, Qualtrics has enhanced oversight clarity and positioned the University for future automation.

Limitations:: A key limitation is that the University does not have an electronic IRB/IACUC submission platform, requiring continued manual Excel tracking for submission deadlines and report reminders. Additionally, investigator adoption was initially slow, necessitating outreach. Since no formal PAM system existed before Qualtrics, pre-intervention compliance metrics were unavailable, limiting comparative analysis. However, structured, survey-based monitoring has improved compliance oversight and provides a scalable alternative for institutions without dedicated compliance software.

Discussion: : This program demonstrates that Qualtrics can enhance PAM in small IRB/IACUC offices without electronic compliance systems. While manual tracking remains necessary, Qualtrics improves data structure, investigator engagement, and oversight efficiency.

Future directions include:
1. Exploring Qualtrics workflow automation: Setting automated alerts for reporting deadlines.
2. Reducing manual tracking: Investigating integration with compliance databases.
3. Building compliance risk dashboards: Leveraging Qualtrics analytics for real-time risk assessment.

This approach is replicable at other institutions that lack electronic compliance software and seek a cost-effective PAM solution.