Protocol Deviation Management Excellence

Course Description

The Protocol Deviation Management Excellence (ProDevME) training program is designed to equip clinical research professionals with the knowledge and skills necessary to effectively identify, assess, manage, and report protocol deviations in clinical trials. This comprehensive training will empower participants to navigate the challenges of protocol deviations while ensuring patient safety, data integrity, and regulatory compliance. Below is the course outline: - Understanding Protocol Deviations: Introduction to protocol deviations and their significance. - Classification of protocol deviations: major vs. minor deviations. - Regulatory guidelines and industry standards related to protocol deviations. - Impact of protocol deviations on trial integrity and patient safety. - Protocol Deviation Management and Reporting. - Identifying common causes of protocol deviations. - Developing a proactive approach to preventing protocol deviations. - Investigating and assessing protocol deviations. - Implementing corrective and preventive actions (CAPAs). - Real-Life Case Studies: Analyzing real-world scenarios involving protocol deviations. - Group discussions and problem-solving exercises. - Practical strategies for addressing various types of deviations. - Reporting and Documentation. - Creating an effective protocol deviation reporting process. - Communication strategies with sponsors, ethics committees, and regulators. - In-class discussions and Q&A sessions to reinforce understanding. Group exercises and case study analysis for practical application