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.