SAS BASE/ADVANCED/CLINICAL By NIKHIL ANALYTICS Page 1

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Course Topics 1) SAS/Base 2) SAS/ODS 3) SAS/ GRAPH 4) SAS/ SQL 5) SAS/ MACROS 6) SAS/ STAT 7) SAS/ACCESS 8) SAS/CLINICAL TRIAL PROCESS 9) SAS/CLINICAL TRIAL DATA STRUCTURE DATA 10) SAS/ IMPORT AND EXPORT CLINICAL TRIALS DATA 11) SAS/ MANAGE CLINICAL TRAILS DATA 12) SAS / TRANSFORM CLINICAL TRIALS DATA 13) SAS / STATISTICAL PROCEDURES FOR CLINICAL TRIALS 14) SAS/ MACROS FOR CLINICAL TRIALS 15) SAS / REPORTS FOR CLINICAL TRIALS 16) SAS / VALIDATION OF CLINICAL TRIALS REPORT 1) SAS/BASE: I. Introduction Introduction SAS. Log File Output File Work File Permanent SAS datasets Environments where SAS runs SAS System Options Step boundaries and run-group processing II. Advanced Input Features Where is my raw data? INFILE DATALINES Input statement Column INPUT Formatted INPUT

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List INPUT MISSOVER, DLM Informats with list INPUT : (colon) and & (Ampersand) Modifiers Advanced input pointers Formatted lists with pointers Reading multiple line input Multiple INPUT statements / and # pointers Black box of SAS Programming The trailing @ The double trailing @@ III. DATA step functions Character functions (Left, Right, Tranwrd, translate ,Index,Indexw, Indexc, Find,Trim,catx, catt, cat, cats, Compress, Scan, Substr, Upcase, Lowcase , Strip etc.) Numaric functions (Int, ceil, floor, Round, abs ,Min, Max, sum, mean, lag, dif). Date Function (Today, Datetime, Time, Timepart, Datepart,Day,Month, Year, Qtr, MDY etc ). IV. SAS Structures and Flow DATA step overview LENGTH FORMATS, INFORMATS, LABELS Titles and Footnotes Reading existing SAS datasets with SET Assignment statements RENAME DROP and KEEP Subsetting observations Subsetting IF statement If, If- then, Else-if, If then Do. WHERE statement V. SAS Do-loops Syntax How to create Do loops. Conditional Do loops(DO until, DO while, by clause). Nesting DO loops. Arrays VI. SAS Executable Statements Accumulating totals RETAIN and SUM SUM statement

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SELECT statement Deleting observations Numeric-character conversion OUTPUT PUT VII. Procedures Proc Print Proc Contents Proc Sort Proc Means Proc Freq Proc Report Proc Tabulate Proc Printto Proc Dataset Proc Compare Proc Transpose Proc Format (input, put function, creating permanent format) Proc Import Proc Export Proc Append Proc Summary VIII. Merging SAS Datasets Syntax One to one merges Match merging Multiple OBS with the same BY variable Merging with identical variable names Merging without a common variable Update statement 2. SAS/ODS: ODS /Trace/Select/Exclude ODS /HTML FILE ODS/PDF FILE ODS/RTF FILE PROC PRINT WITH STYLE OPTION PROC REPORT WITH STYLE OPTION PROC TABULATE WITH STYLE OPTION 3. SAS/GRAPH: Proc PLOT

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Proc GPLOT Proc CHART Proc GCHART 4. SAS/SQL: SQL/CREATE TABLE SQL/ALTER SQL/DROP SQL/INSERT SQL/UPDATE SQL/SELECT SQL/DELETE SQL/WHERE SQL/OPERATORS SQL/JOIN SQL/UNION SQL/ORDER BY SQL/GROUP BY 5. SAS/MACROS: X. An Introduction to SAS Macros Functions of the SAS macro processor Macro processor flow Macro and macro variable Defining and using a macro Creating macro variables 3 ways Local and global macro Automatic macro variables Avoid macro errors Positional macro parameters Keyword macro parameters Call Symput and Symget System options for debugging macro 6. SAS/STATISTICS: Proc UNIVARIATE Proc MEANS Proc FREQ (Chi-Square) Proc GLM Proc RANK Proc ANOVA Proc REG

Proc LOGISTIC (logistic Regression) Proc TTEST (Paired)

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Proc CORR (correlation) 7. SAS/ACCESS: How to connect with data server Libname Code Sql Code

Clinical Trials Programming Using SAS 9

8. SAS/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).

9. 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.

10. IMPORT AND EXPORT CLINICAL TRIALS DATA: Combine SAS data sets. Efficiently import and subset SAS data sets. Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT). Create temporary and permanent SAS data sets. Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

11. MANAGE CLINICAL TRIALS DATA: Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ). Access DICTIONARY Tables using the SQL procedure. Sort observations in a SAS data set. Create and modify variable attributes using options and statements in the DATA step. Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

12. TRANSFORM CLINICAL TRIALS DATA: Process data using DO LOOPS. Process data using SAS arrays. Retain variables across observations. Use assignment statements in the DATA step.

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Apply categorization and windowing techniques to clinical trials data. Use SAS functions to convert character data to numeric and vice versa. Use SAS functions to manipulate character data, numeric data, and SAS date values. 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.

13. 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 (2x2 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.

14. 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). 15. 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.

16. 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.