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cAbstract
The privacy of any subject who participates in a clinical study must be protected for ethical and legal reasons. Clinical data management professionals must be familiar with privacy laws that exist for the regions in which clinical studies are occurring and ensure all reasonable and appropriate precautions are taken. This chapter discusses strategies and considerations that data managers must understand and follow, including the varying types of personal data in clinical studies, best practices for securing and protecting data (both paper and electronic), methods of data collection, and strategies for ensuring that personnel, both internal and external (e.g., vendors), follow applicable data privacy standards.
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