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This document presents DataSetBuilder, an application designed to assist non-programmers in creating edit check test cases for clinical data validation within SAS datasets, utilizing an Excel interface
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How to fill out PharmaSUG 2013 - Paper AD06

01
Gather all necessary data that will be included in the analysis.
02
Ensure you have the latest version of SAS and any required libraries installed.
03
Review the paper for specific examples of code and data formats used.
04
Start by creating a project directory to organize your files.
05
Write the SAS program as outlined in the paper AD06, ensuring to modify any examples to fit your dataset.
06
Run the SAS program and validate the output against the examples provided.
07
Document any changes made to the original example for future reference.

Who needs PharmaSUG 2013 - Paper AD06?

01
Statisticians and data analysts working in the biopharmaceutical industry.
02
Regulatory professionals who need to comply with submission guidelines.
03
Researchers involved in clinical trials who need to present data analysis.
04
Students learning how to prepare and analyze clinical trial data.
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PharmaSUG 2013 - Paper AD06 is a paper presented at the Pharmaceutical Industry SAS Users Group annual conference, focusing on the topics related to the usage of SAS in clinical research and regulatory submissions.
Professionals in the pharmaceutical industry, including statisticians, regulatory professionals, and data analysts, who are involved in clinical trials and need to submit regulatory documents are required to reference and follow guidelines from PharmaSUG 2013 - Paper AD06.
To fill out PharmaSUG 2013 - Paper AD06, individuals should follow the templates and guidelines provided in the paper, ensuring that all necessary data and statistical analyses are compliant with regulatory standards.
The purpose of PharmaSUG 2013 - Paper AD06 is to provide guidance and best practices for the use of SAS in clinical trial data analysis and reporting, facilitating effective communication of results to regulatory authorities.
The information that must be reported includes statistical methodologies, analysis results, and any relevant findings from clinical trials, as well as compliance with regulatory requirements for submission.
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