clinical trial site training, quality risk management, active learning methods, adult learning principles
Objective: The objective of this poster presentation is to help sponsors, monitors and clinical research site managers design and conduct more meaningful and effective site staff training activities in order to enhance the implementation of study protocols in accordance with the investigational plan and thus improve quality risk management.
Content: The U.S. Food and Drug Administration (FDA), the International Council on Harmonization (ICH) and the European Medicines Agency (EMA) emphasize that sponsors should choose investigators, clinical research site staff and monitors that are qualified by education, training and experience. In addition, these entities have taken a more risk-based approach to managing and monitoring risks in recent years. This approach consists of focusing oversight on the risks related to human subjects protection, data integrity and investigation quality. All processes used to prevent and mitigate risks should be in direct proportion to the seriousness and likelihood of these risks. The ICH E6 (R2) noted that effective training in processes and procedures is one of the risk reduction activities that sponsors should employ. FDA’s 2013 guidance on risk-based monitoring noted that investigators and clinical research site staff need “meaningful training” prior to and during the conduct of a study in order to execute it correctly. In FY 2017, the most frequent finding on FDA Form 483 that was issued from inspections by FDA’s Bioresearch Monitoring Program was failure to conduct the investigation in accordance with the investigational plan. A common citation noted in warning letters to sponsors and investigators was the failure to have effective training and retraining activities. The challenge, therefore, is to design and conduct training activities that are meaningful and effective in order to correctly execute study protocols and reduce risks to human subjects protection, data integrity and investigation quality. Educational research has shown that active learning methods are much more effective at enhancing knowledge transfer and retention than passive learning methods such as reading, listening or watching a webcast. In this poster presentation, I will discuss various active learning methods that can be used to design and conduct meaningful and effective site training activities. I will discuss how these methods can be combined with adult learning principles and risk identification/assessment tools to design a site staff training plan that will identify the Critical to Quality (CTQ) factors, enhance the prevention and mitigation of risks that matter, and help staff to execute the study protocol in accordance with the investigational plan.