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Clinical Data Management培训
课程介绍：
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最新时间：定制课程(内训)，人满开班(公开课)
课程大纲：
Class Description
• Protocol review
• CRF design and completion guidelines
• Developing a Data Management Plan
• Data validation/edit checks
• Data capture techniques – paper and electronic
• Data coding dictionary
• Database structures
• Database lock
• Storage and recreation of clinical data
• Introduction to regulatory requirements: ICH and FDA guidance
• Introduction to CDISC Standards Relevant to e-Clinical Trials
• Protocol review
• CRF design and completion guidelines
• Developing a Data Management Plan
• Data validation/edit checks
• Data capture techniques – paper and electronic
• Data coding dictionary
• Database structures
• Database lock
• Storage and recreation of clinical data
• Introduction to regulatory requirements: ICH and FDA guidance
• Introduction to CDISC Standards Relevant to e-Clinical Trials
