T-27: Key Aspects and Lessons Learnt for Maintaining a Robust and Efficient Global 24/7 Medical Emergency Coverage Service
Medical Director, Medical Affairs
ICON, plc. United States
Analysis of key elements and process requirements to maintain and continuously optimize a fully robust and efficient global 24/7 medical emergency coverage system within a global Contract Research Organization (CRO).
Continuous review and process optimization of a global 24/7 medical emergency service for fatal or life-threatening events, intoxications with an investigational product, or urgent safety issues. Analysis is based upon results and outcome of real emergency calls, test calls, audits and inspections.
A ‘follow-the-Sun’ principle has been applied to this global 24/7 service. Four 24/7 physicians globally are on-call each week with one physician on-call per region (APAC, Europe, LATAM, North America). A single HelpDesk (HD) call centre acts as central point of contact for the sites. Depending on the time of the day, 24/7 calls will be transferred by the HD Operations Support Analyst (OSA) to a 24/7 physician who is currently during his/her day time. Transfer of the call does not depend on the region of the caller.
• Dedicated 24/7 medical administrative team (MAT)
• 24/7 accessible, central document repository
• Quarterly test calls by the 24/7 MAT
• Periodic calls between 24/7 MAT and HD oversight team.
• Periodic motivational/background calls to the OSAs
• Regular email refreshers to all OSAs on key 24/7 aspects
• Case scenarios with active feed-back request to the OSAs. Refresher training as needed
• Confirmation to the 24/7 MAT on upload of new on-call physicians rota plans or study lists.
Language line at the HD:
• Ability to immediately conference-in a translator
• Menu prompt options for language support.
Study integration and document management:
• Confirmation from each 24/7 physician that he/she is not assigned as unblinded Medical Monitor (MM) or has otherwise access to unblinded data for that drug
• Study lead MMs must send all 24/7 documents to the 24/7 MAT prior to service start. Pro-active document up-dates once available.
• Documented provision of 24/7 contact details to sites in monitoring trip reports.
Quarterly up-dates checks:
• Requesting all study lead MMs to confirm that all 24/7 documents are complete and still valid or if new documents are available for their study/ies
• Check for new studies to be integrated.
• Detailed tracking of all calls including internal and external test calls
• CAPA for each call not handled in line with the process flow.
• During business days, the 24/7 physician can directly check with an assigned study MM if he/she is not involved in that study
• Should prevent answering of calls during the night
• Each physician on-call must be available 24/7 to act as back-up, if the HD OSA cannot reach the 24/7 physician who should be contacted as per time of the day.
Within a global CRO, study MMs are assigned to multiple projects. Pro-active support needs to be provided to the MMs to ensure that the 24/7 MAT has all the latest documents and is informed of any new study integration. Quarterly up-date checks have been implemented asking for active feed-back on current document versions and new studies for integration. For each study, all 24/7 physicians must actively confirm their blinding status to avoid having unblinded MMs working on the 24/7 rotation.
Menu prompt options for language support need to be available when using a single HD call centre (English as default language). Conferencing-in of a translator must be possible within minutes.
24/7 medical emergency calls are rare. It is challenging for the HD OSAs and 24/7 physicians to develop a routine. Periodic test calls are mandatory. In addition for the HD, at least monthly refreshers and case scenarios for the OSAs requesting active feed-back significantly helped keeping the process flow fresh and on everyone’s mind.
Several back-up layers and constant re-evaluation are required for a robust 24/7 medical emergency service ensuring 24/7 availability of a qualified physician and fully up-to-date 24/7 study documents. Scope of such robust system could be expanded to not only cover for medical emergencies. Other options include e.g. 24/7 availability of trained MMs for eligibility checks in studies with time-critical enrolment or 24/7 support for specific adverse event handling procedures and algorithms in e.g. Oncology studies.
Co-author: Michael Marx, MD