Expanding a Post-Approval Monitoring Program: Building on Success


Program Description
A successful PAM program begins with focusing on one goal and one measurable outcome. Our institution initiated a PAM program in order to build a collaborative, mutually educational platform to promote compliance and best practices. Since issues relating to informed consent are common in audit findings, the initial focus of our program involved reviewing the process and documentation of informed consent. Targeted and global education and policy revisions were implemented as a result of the initial phase of this program, which was later expanded to address additional opportunities for process improvement. 

After approximately one year of data collection, a systematic review was conducted which included: 1) the primary and secondary findings; 2) the impact of education and direct mentoring regarding common findings, including direct feedback from research personnel via online survey; and 3) commonly asked questions and/or areas of concern brought to the attention of the IRB/compliance office during PAM reviews. 

Of the first 26 studies monitored in this program, inadequacies relating to the documentation of the consent process occurred in 20 (77%) and inconsistencies in properly obtaining signatures occurred in 17 (65%). In response to these findings, both targeted and global education was provided. Policies and procedures were revised to provide further clarification and guidance. 

Since the initial review period, the focus of the PAM has been expanded to address other areas of concern (i.e., review of participant eligibility and maintenance of regulatory documents). Subsequently, 16 additional studies have been monitored. Inadequacies in documentation of the consent process were found in 7 (44%) and errors relating to signatures occurred in 9 (56%) of these studies. These results reveal that while errors relating to informed consent are still common, there has been a significant overall reduction in the occurrence of errors (p=0.05). 

The data presented illustrates that a simple, collaborative PAM program with clear objectives can directly impact the number of inadequacies being noted. Further, this program offers a platform from which to evaluate other areas of concern. Starting from the initial focus of consent process monitoring has allowed us to identify areas needing additional review, and ongoing analysis of data will continue to measure the impact and help determine future goals and objectives.