Final ICH GCP E6 R2: Impact on Clinical Data Management January 2019

Jan 30, 2019
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Course Description

Clinical Data Management plays a significant role in the performance of clinical trials. ICH GCP E6 R2 reinforces the requirements in regards to electronic systems and the Standard Operating Procedures (SOPs) that govern processes specific to these systems. In this web seminar, a review of these requirements as well as an examination of the components of quality management are covered. Further, the role that risk has on the overall conduct of clinical trials will be discussed, particularly since this concept will be the standard way forward (rather than an option). We will also review recommended approaches, industry standards/best practices to achieve compliance with the requirements.

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Learning Objectives

  • Define the recommended SOPs associated with electronic systems used to collect clinical trial data
  • Discuss data integrity issues described in the final guideline
  • List the considerations of risk associated in clinical trial conduct and its connection to Clinical Data Management
  • Review the principles of quality management as related to clinical trials and the tools utilized to implement a quality approach

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 +1 215.413.2471.