Course Description

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

In this web seminar, we will explore the data quality definitions, processes involved in determination of quality, and the rationale utilized in ensuring data quality. It’s not about the individual data point anymore.

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Learning Objectives

• Describe a quality system approach for assuring appropriate data quality
• Identify data discrepancies, errors, outliers and bias and how to assess their importance
• Describe how poor data quality may or may not impact study operations or analysis
• Compare and contrast common approaches to discrepancy identification and resolution

Who Should Attend

• Clinical Data Managers
• Quality Assurance 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.