Register for SCDM’s upcoming Online Course November 27 – December 17

Influence of Randomization and the Statistical Analysis Plan (SAP) on Data Collection

Overview

This three-week course will focus on understanding the Randomization process and the Statistical Analysis Plan (SAP), as well as how they affect data management activities, such as collection/validation and data quality/integrity. Participants will explore how the SAP affects data collection and data validation. Together with the instructor, they will solve the randomization mystery through an overview of what randomization schemes are all about and how they effect the work of the Data Manager. Lastly, the course will review how EDC/CTMS databases can be integrated with Randomization systems. Throughout the course, the emphasis will be put on ensuring regulatory compliance, particularly by working with example situations that were not planned for.

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