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TekSlateSAS Clinical Online TrainingIntroduction to SAS Clinical TrainingSAS Clinical Data Integration is a new product offering from SAS that focuses on pharmaceutical industry needs for managing, verifying and transforming the creation of industry mandated data standards such as the Clinical Data Interchange Standards Consortium (CDISC). The product relies on SAS Data Integration to provide centralized metadata management using the SAS Metadata Server and the tools to visually transform data. SAS Clinical Training enhances usability by adding new metadata types, wizards and plug-ins that assist with clinically oriented tasks.Course CurriculumUnit 1: Clinical Trials Process

Topics-Describe the clinical research process (phases, key roles, key organizations),Derive programming requirements from an SAP and an annotated Case Report Form,Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).

Unit 2: Clinical Trials Data Structures

Topics- Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.),Identify key CDISC principals and terms,Describe the structure and purpose of the CDISC SDTM data model,Describe the structure and purpose of the CDISC ADaM data model,Describe the contents and purpose of define.xml.

Unit 3: Import and Export Clinical Trials Data

Topics- Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Unit 4: Manage Clinical Trials Data

Topics- Access DICTIONARY Tables using the SQL procedure.Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

Unit 5: Macro Programming for Clinical Trials

Topics- Create and use user-defined and automatic macro variables.Automate programs by defining and calling macros,Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).

Unit 6: Report Clinical Trials Results

Topics- Use PROC REPORT to produce tables and listings for clinical trials reports.Use ODS and global statements to produce and augment clinical trials reports.

Unit 7: Validate Clinical Trial Data Reporting

Topics- Explain the principles of programming validation in the clinical trial industry,Utilize the log file to validate clinical trial data reporting,Use programming techniques to validate clinical trial data reporting (PROC COMPARE),Identify and Resolve data, syntax and logic errors.

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