SCORE Half-Day Seminar: A Minds-On Practice

The Study Coordinators Organization for Research & Education (SCORE) recently held its 8th annual Half-Day Seminar. This year, the seminar included lectures on self-determination theory, standard operating procedures, and mindful practice, and also focused on root cause analysis, a method of reviewing adverse events that occur in clinical research in order to prevent recurrence.

SCORE, which is part of the Clinical and Translational Science Institute, provides support and networking opportunities for research coordinators and staff across the University of Rochester. With recent changes in Food and Drug Administration guidelines for investigation of adverse events in clinical trials, some of the burden of root cause analysis has fallen to study coordinators and research nurses.

Multi-Cultural Office Staff Sitting Having Meeting TogetherThat is why the Seminar Planning Committee, according to Nancy Needler, Manager, CTSI Research Coordinator Program decided to include a hands-on and “minds-on” root cause analysis practice in breakout sessions this year – a first for the SCORE Half-Day Seminar.

The hands-on practice was kicked off with a lecture on root cause analysis by Michael Leonard M.D. M.S., associate professor of Pediatrics and associate chief quality officer for UR Medicine. During his lecture, Leonard and a group of actors introduced a hypothetical scenario of an adverse event in clinical research. In the scenario, a teenaged participant in a clinical trial for a depression medication was sent to the emergency department after overdosing on the study drug.

According to Needler, key information was purposefully left out of the scenario introduction, “because you never have all of the information from an event in normal life situations.”

Seminar participants had the opportunity to gather more information by asking the actors questions prior to breaking into groups for discussions with trained facilitators. The seminar participants divided into six groups to review the facts and find areas or policies that could be changed to prevent this adverse event from happening again.

“What I thought was wonderful from all of the teams,” says Needler, “was that none said ‘it was so-and-so’s fault’. They all examined the process; not the person.”

That is key in root cause analysis. The goal is to identify the sources of error in a systematic process and to develop approaches that address the root of the issue.  The seminar’s scenario reflects the reality that research teams plan and manage study activities with the utmost focus on ensuring participant safety and maintaining data integrity.

The presentation that followed the root cause analysis activity was an orientation to the development of Standard Operating Procedures (SOPs), which are a set detailed instructions for each process used in a clinical study. Root cause analysis often leads to development or modification of SOPs in order to prevent future adverse effects or breaches of protocol.

Closing the Half-Day, attendees participated in a mindful exercise guided by Ronald Epstein MD, professor of Family Medicine, Psychiatry and Oncology at URMC.   Attendees were introduced to the concepts of mindfulness, to promote resilience and well-being in the workplace.

The seminar was well-attended with 123 participants from 9 institutions, with over 30 University of Rochester departments represented.

Practice Root Cause Analysis at SCORE Half Day Seminar

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The registration deadline to attend the 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half Day Seminar is quickly approaching.  This year’s seminar will feature a simulation of root cause analysis, a methodology to review adverse events, identify key causes and contributing factors and implement system-based solutions. Recent changes to guidelines for investigation and prevention of non-compliance in clinical trials require sponsors and often research teams (study coordinators and research nurses) to be able to perform root cause analysis.

Clinical trial protocols are designed to examine specific scientific questions while minimizing risks to patient safety and maintaining data integrity.  Clinical trials have become increasingly large and complex over the past few decades. It is not uncommon for a trial to have many sites that span the nation or the globe and study teams that may change in personnel during the trial. This increased complexity leads to greater risk of errors and non-compliance, resulting in deviations from the protocol.

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, has set expectations that all sponsor or clinical research organization (CRO) personnel should review the monitoring plan and be prepared to perform a root cause analysis, and to implement appropriate corrective and preventative actions when deviations occur.

When things go awry in clinical research, it is essential to understand the underlying cause(s) of the error or protocol failure. Root cause analysis gets to the core of the issues, which are often related to system defects in communication, policies and processes, environment, information management and/or human resources. Depending on the root cause identified, system-based solutions are designed to reduce or eliminate the risk of the event recurring.

One thing to keep in mind is that, by their very nature, root cause analyses are not one-size-fits-all. The nature of issues and the optimal intervention will vary from site to site and from study to study. This is why it is important to do a thorough assessment of each critical issue as it arises and devise targeted solutions to prevent future issues.

To learn more about root cause analysis and the expectations for study coordinators and research nurses, register for the SCORE Half Day Seminar.

The seminar will be held on Tuesday, June 7th in the Ryan Case Method room in the URMC with live streaming available at an overflow site. Parking will be available for non-UR attendees for $6 fee.

For more information, please contact SCORE@urmc.rochester.edu.