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Using SAS software to fulfil an FDA request for database documentation Pantaleo Nacci, Adam Crisp Glaxo Wellcome R&D, UK Introduction Historically, a regulatory submission to seek approval for a new drug (or for a new indication of an already marketed one) consists of a huge amount of paper; lately various regulatory authorities, and particularly the Food and Drug Administration (FDA), have begun to allow the presentation of Clinical Report Forms (CRF) and Clinical Report Tabulations (CRT) in
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Step 1: Open SAS software on your computer.
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Step 2: Create a new program by selecting 'File' > 'New Program'.
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Step 3: Input your data either by importing a dataset or by writing data steps in the program editor.
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Step 4: Use PROC procedures to analyze your data, for example, 'PROC MEANS' to summarize the dataset.
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Step 5: Customize any graphs or tables using SAS graphics procedures if needed.
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Step 6: Run the code by clicking on the 'Run' button or pressing F3.
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Step 7: Review the output displayed in the Output window to interpret your results.

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Data analysts who need to analyze large datasets.
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SAS software is used for advanced analytics, business intelligence, data management, and predictive analytics.
Organizations and professionals who need to analyze large sets of data or generate statistical reports are typically required to file using SAS software.
To fill out using SAS software, you need to input your data into the software, choose the appropriate procedures for analysis, and follow the steps to generate your reports or outputs.
The purpose of using SAS software is to facilitate data analysis, improve decision-making capabilities, and enhance business processes by turning raw data into meaningful insights.
Information that must be reported using SAS software typically includes data analysis results, statistical outputs, trends, and insights relevant to the project or research being conducted.
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