Data Coding

Progress towards the creation of uniform standards for the collection, reporting, and analysis of data is being made on several fronts. Although there are many practical obstacles to overcome, the use of data standards has the potential to change the scientific landscape. To prepare for this Application Assignment, review this week’s Learning Resources about the various coding dictionaries and data standards. To complete this Application Assignment, write a 1 page paper in which you address the following: • Describe the differences between the MedDRA and WHO Drug coding dictionaries. Provide examples of how each would be used in a clinical trial and assess their respective advantages and drawbacks. • Describe CDISC and how it differs from a coding dictionary. Assess its potential use and impact on clinical trials, the obstacles to its acceptance and adoption, and how they might be overcome.

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