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Here are the topics of Clinical Trials Programming Using SAS 9 Accelerated Version (A00-281) Exam
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Clinical Trials Process
- Interpret a Statistical Analysis Plan.
- Derive programming requirements from an SAP and an annotated Case Report Form.
- Automate programs by defining and calling macros.
- Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
- Obtain counts of events in clinical trials. Apply Statistical Procedures for Clinical Trials
- Calculate ‘change from baseline' results.
- Describe the clinical research process (phases, key roles, key organizations).
- Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices). Clinical Trials Data Structures
- Identify and Resolve data, syntax and logic errors.
- Create and use user-defined and automatic macro variables.
- Describe the structure and purpose of the CDISC ADaM data model.
- Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
- Apply regulatory requirements to exported SAS data sets (SAS V5 requirements). Manage Clinical Trials Data
- Identify key CDISC principals and terms.
- Describe the contents and purpose of define.xml. Import and Export Clinical Trials Data
- Use PROC REPORT to produce tables and listings for clinical trials reports.
- Apply ‘observation carry forward' techniques to clinical trials data (LOCF, BOCF, WOCF).
- Create output data sets from statistical procedures. Macro Programming for Clinical Trials
- Use ODS and global statements to produce and augment clinical trials reports. Validate Clinical Trial Data Reporting
- Transpose SAS data sets.
- Use PROC FREQ to obtain p-values for categorical data (2x2 and NxP test for association).
- Describe the structure and purpose of the CDISC SDTM data model.
- Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc). Transform Clinical Trials Data
- Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
- Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN). Report Clinical Trials Results
- Access DICTIONARY Tables using the SQL procedure.
- Explain the principles of programming validation in the clinical trial industry.
- Utilize the log file to validate clinical trial data reporting.
- Apply categorization and windowing techniques to clinical trials data.
- Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
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Duration, language, and format of Clinical Trials Programming Using SAS 9 Accelerated Version (A00-281) Exam
Format: Multiple choices, multiple answers
- Length of Examination: 2 hours
- Language: English
- Passing score: 70%
- Number of questions: 70-75
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