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Nov 22, 2009
Clinical Trials Terminology for SAS Programmers
The drug development process is a clinical process that has its own language. It is not required that SAS programmers function as a MD or a regulatory expert, but working knowledge of the terminology is important to be effective. This paper will walk through the drug development process from discovery to Phase IV. It will explain a wide range of acronyms such as IND, NDA, GCP and MedDRA. It will also describe some of the terminologies used within the process of clinical trials as a drug is developed and submitted to the FDA. This will give SAS programmers a larger perspective and context to their work during the analysis and reporting of clinical trials data.