8 - From Anxious to Prepared: How an Interactive Educational Session About FDA Audits Helped a Research Community

Background: Anticipating a FDA audit can be nerve-wracking. Researchers are often concerned about having a governmental agency scrutinize their work and are unsure of how to best prepare. We designed a workshop to arm the community with information about what to expect during these audits.

Program

Description: An interactive/hands-on educational session was implemented to support team members involved with research. A pre-session survey was sent to registrants to establish a knowledge and preparedness baseline level. The session commenced with a presentation by our health network’s designated research auditor, who provided an overview of what an audit entails, including the logistics of executing the audit and the documents that will likely be reviewed. For the second portion of the event, participants were divided into small groups and provided with mock regulatory binders with planted “mistakes” in the documents. Attendees were encouraged to identify the mistakes, just as an auditor would. Next, the attendees rejoined the main session which was focused on the discussion and “debriefing”. Finally, the research auditor presented tips and ideas for staying “audit ready.” A post-session survey was sent to all attendees to re-evaluate knowledge and preparedness right after the educational session.

Program

Assessment: The primary focus of the survey was the level of preparedness before and after the session. Participants were asked to self-assess their preparedness using a 5-point Likert scale ranging from “I feel completely unprepared” to “very well prepared.” A significantly higher proportion of respondents reported feeling prepared after the educational session (p=0.007). After collapsing “preparedness” to positive, neutral, or negative, a Chi-Square Test of Independence was performed to assess the relationship between time and preparedness. A marked increase in attendees’ “preparedness” rating following the educational session was noted [X2(2) = 12.337, p = 0.002, n=69]. The noted change suggests that the program was successful in boosting researchers’ perspectives regarding audit preparedness with many of them feeling better understanding the expectations and process followed during an FDA audit. Future research could focus on sustainability of preparedness and whether such interactive sessions have an impact on overall compliance.

Limitations: The original intention of the project was not research and, as a result, a thorough statistical analysis plan was not designed from the onset. Ideally, the pre and post data should have been paired to allow for a more sophisticated analysis.

Discussion: This session will be offered again for those who were unable to attend the first time around. We anticipate that this type of session may help to promote compliance in our institution and in others. We believe that offering an educational session that was both instructional and hands-on enabled researchers to better grasp what audits entail and what measures need to be taken to prepare for them. When researchers have the tools to prepare, they can do so more effectively.