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Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)

Course #: BI13626
September 17, 2019

Course Description

The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials. Practical information and a systematic approach in assessing organizational SOPs, processes and practices as well as designing modifications to assist with implementation will also be provided.

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Learning Objectives

  • Identify the changes impacting investigator responsibilities and roles
  • Explain the impact of the revisions to sites and Sponsors-Investigators
  • Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training
  • Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline

Who Should Attend

  • Quality Assurance/Compliance Personnel
  • Principal Investigators/Sub-Investigators
  • Research Site Staff (Managers, CRCs, Data Managers/Data Entry)
  • Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
  • Study Managers/Project Managers, CRAs/Monitors (Centralized, On-site)


Mary Mills, R.N., C.C.R.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.