SAS Clinical Online Training Course Content:

SAS Clinical  Course Content:

Duration:4-5 weeks

Clinical Trials Process

Describe the clinical research process (phases, key roles, key organizations). Interpret a Statistical Analysis Plan.

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).

Clinical Trials Data Structures

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.

Import and Export Clinical Trials Data

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

Manage Clinical Trials Data

Access DICTIONARY Tables using the SQL procedure.

Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

Transform Clinical Trials Data

Apply categorization and windowing techniques to clinical trials data. Transpose SAS data sets.

Apply ‘observation carry forward’ techniques to clinical trials data (LOCF, BOCF, WOCF). Calculate ‘change from baseline’ results.

Obtain counts of events in clinical trials.

Apply Statistical Procedures for Clinical Trials

Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).

Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association).

Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests). Create output data sets from statistical procedures.

Macro Programming for Clinical Trials

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).

Report Clinical Trials Results

Use PROC REPORT to produce tables and listings for clinical trials reports.

Use ODS and global statements to produce and augment clinical trials reports.

Validate Clinical Trial Data Reporting

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, MSGLEVEL). Identify and Resolve data, syntax and logic errors.

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