Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’


Problem Statement
Our research program consists of approximately 900 active studies. Formerly, PAM activities were conducted by the HRPP director, and the majority of such visits were “for cause.” This became increasingly difficult with program growth and the director’s increasing responsibilities. The institution recognized the need for dedicated PAM and education. However, routine monitoring through the HRPP office is an unfamiliar concept to most investigators. Concern arose about how best to introduce this new program in a way that fosters cooperation and reduces fear. 

We introduced our program through a soft rollout to enhance acceptance. This was followed with system wide education and discussion of preliminary findings. Nine regulatory attributes/topics were selected, comprising 82 variables for review (“Attributes Legend”). A self-assessment tool was created for investigators based on the attributes legend. Investigators were then selected for the soft rollout based on experience level, study volume, experience with routine monitoring, and cooperation. Investigators or research teams were chosen on familiarity, and they decided which study would be monitored. Ten investigators agreed to participate and one declined. Research staff were asked to complete the self-assessment tool prior to the monitoring visit. These visits included a review of the regulatory binder, the consent process, and a review of approximately two to 10% of the subject charts. All monitoring visits culminated with a review of the findings from the attributes legend with the investigator and/or research team. The research team received a follow-up monitoring report outlining findings and corrective actions, including a compliance score for each attribute and overall. Staff were given approximately four weeks to respond to any corrective actions.

Conclusion/Next Steps
Attributes with poorest compliance revealed: 1) lack of regulatory documentation, including updated personnel lists, CVs, and training; 2) lack of oversight; 3) misunderstanding about reporting; and 4) misconceptions about data security. After completion of the soft rollout, system wide education was provided to research teams about PAM: what to expect, how to prepare, and preliminary findings from the soft-rollout. Sharing the findings and providing tools on how to prepare should facilitate ease of transition into a monitoring program. Support from the Institutional Official (IO) was imperative for acceptance of the program; the IO invited staff to present preliminary findings to executives and held meetings which resulted in discussions to engage investigators. A database was created to track compliance ratings by attribute, investigator, and department. The next step will be to compare compliance outcomes over time and track continuing noncompliance.