Course Description

Clinical Data Management (CDM) plays a pivotal role in the success of clinical trials, ensuring data accuracy, integrity, and compliance with regulatory requirements. The ICH GCP E6(R3) update refines the approach to CDM by incorporating a risk-based framework for managing data and enhancing oversight mechanisms. This web seminar will explore the updated guidelines, focusing on the evolving requirements for electronic systems, data integrity, and the integration of quality management principles throughout the trial lifecycle. Participants will gain insights into the role of risk management in clinical data collection and analysis, now positioned as a standard practice rather than an optional strategy. The session will also cover best practices, industry standards, and practical approaches to achieving compliance with the revised guidelines. Additionally, the seminar will highlight the implications of the R3 updates and how they reshape CDM processes, ensuring data quality and regulatory adherence.

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Learning Objectives

• Define the recommended SOPs for electronic systems used to collect and manage clinical trial data under ICH GCP E6(R3)
• Discuss data integrity considerations and their critical role in clinical trials, as outlined in the revised guidelines
• Identify risk management principles in clinical trial conduct and their direct connection to Clinical Data Management practices
• Review quality management principles and tools to implement a risk-based quality approach in clinical trials

Who Should Attend

• Clinical Data Managers
• Clinical Data Scientists
• Clinical Quality Assurance Professionals
• Clinical Compliance Personnel

Instructor

Denise G. Redkar-Brown, MT

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Hold this course at your company! For more information, contact Naila Ganatra at +1