Illuminating the Way to Better Business and ComplianceTM Expect the Unexpected: Monitoring Template Tips Most programs stay within their allotted time and budget, and most HCP’s who RSVP show up. However, your monitoring plan may not have been designed to capture the times when the unexpected happens. Perhaps a speaker uses his personal case notes to highlight a specific “patient type”, or a representative uses the program as a forum to solicit off-label use information from the speaker or the attendees, or you discover the venue has created their own special product-branded menu for attendees. Thinking ahead about some of these unanticipated surprises may enable you to design a more robust monitoring template that will help capture what happens in real time during a program. • Try to limit your monitoring template to two pages. Brevity is the soul of wit. • Capture basic logistical information about the speaker, location, topic, company representatives and HCP’s in attendance, and program duration. • Include questions on whether materials distributed or shared were PRC approved or if they were “homemade” by the speaker, representatives or the venue. • Provide some space for additional commentary by the reviewer about the general makeup of the attendee group, the tenor of the discussion, the types of questions asked, and any untoward or unexpected events that occurred during the event. • Focus on your most important risk areas by including questions that highlight how the speaker presented the material, if offlabel discussions or questions occurred, how speaker or representatives responded to or took action on attendee inquires or statements, etc. Once you have designed your template, pilot it during a few subsequent events to see if it allows your monitors to capture all relevant details about each program. Make any necessary adjustments you see. Regular teleconferences or in-person meetings with your monitors to discuss the previous week’s monitoring activities will help you gather feedback and identify potential areas for further exploration or improvement, including changes to company policies or procedures that will help speakers and representatives respond appropriately. For a free consultation, call 435-213-5622 or email us at clabarge@searchlightcompliance.com searchlightcompliance.com
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