Preparing and Classifying Clinical Trial Data

Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40 

This chapter describes the key clinical data preparation issues and the different classes of clinical data found in clinical trials. Each class of data brings with it a different set of challenges and special handling issues. Sample case report form (CRF) pages are provided with each type of data to aid you in visualizing what the data look like. The key data preparation issues presented are concepts that apply universally across the various classes of clinical trial data. 

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Chapter 2 Preparing and Classifying Clinical Trial Data 21... 

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