\\ JOB ORIENTED COMPLETE CLINICAL SAS TRAINING \\

Trainer: Kiran
Website: http://learnsasonline.com
Contact Details : +91 9542357321(Phone and WhatsApp)

Course Duration : 90 hours

Base SAS : 30 hours
Advanced SAS : 10 hours
Clinical SAS : 30 hours
Clinical Project : 20 hours

Specialities
 Latest 9.4 version of SAS Software and all the related softwares will be
installed in the students system.
 Daily tasks will be given after each session.
 30 e-Books, SAS Certification guidance and sample questions, All the
programming files, pdf’s, Datasets etc., will be provided.
 Resume preparation, Interview Preparation, Mock Interviews and Job-
Assistance will be provided.

DETAILED SYLLABUS OF ALL THE MODULES

SAS 9.4 Base Programming

 Create temporary and permanent SAS data sets.

 Use a DATA step to create a SAS data set from an existing SAS data set.
 Investigate SAS data libraries using base SAS utility procedures.
 Use a LIBNAME statement to assign a library reference name to a SAS
library.
 Investigate a library programmatically using the CONTENTS procedure.
 Access data.
 Access SAS data sets with the SET statement.
 Use PROC IMPORT to access non-SAS data sources.
 Read delimited and Microsoft Excel (.xlsx) files with PROC IMPORT.
 Use PROC IMPORT statement options (OUT=, DBMS=, REPLACE)
 Use the GUESSINGROWS statement
 Use the SAS/ACCESS XLSX engine to read a Microsoft Excel
workbook.xlsx file.
 Combine SAS data sets.
 Concatenate data sets.
 Merge data sets one-to-one.
 Merge data sets one-to-many.
 Create and manipulate SAS date values.
 Explain how SAS stores date and time values.
 Use SAS informats to read common date and time expressions.
 Use SAS date and time formats to specify how the values are displayed.
 Control which observations and variables in a SAS data set are
processed and output.
 Use the WHERE statement in the DATA step to select observations to be
processed.
 Subset variables to be output by using the DROP and KEEP statements.
 Use the DROP= and KEEP= data set options to specify columns to be
processed and/or output.
 Sort observations in a SAS data set.
 Use the SORT Procedure to re-order observations in place or output to a
new dataset with the OUT= option.
 Remove duplicate observations with the SORT Procedure.
 Conditionally execute SAS statements.
 Use IF-THEN/ELSE statements to process data conditionally.
 Use DO and END statements to execute multiple statements
conditionally.
 Use assignment statements in the DATA step.
 Create new variables and assign a value.
 Assign a new value to an existing variable.
 Assign the value of an expression to a variable.
 Assign a constant date value to a variable.
 Modify variable attributes using options and statements in the DATA step.
 Change the names of variables by using the RENAME= data set option.
 Use LABEL and FORMAT statements to modify attributes in a DATA
step.
 Define the length of a variable using the LENGTH statement.
 Accumulate sub-totals and totals using DATA step statements.
 Use the BY statement to aggregate by subgroups.
 Use first. and last. processing to identify where groups begin and end.
 Use the RETAIN and SUM statements.
 Use SAS functions to manipulate character data, numeric data, and
SAS date values.
 Use SAS functions such as SCAN, SUBSTR, TRIM, UPCASE, and
LOWCASE to perform tasks such as the tasks shown below.
 Replace the contents of a character value.
 Trim trailing blanks from a character value.
 Search a character value and extract a portion of the value.
 Convert a character value to upper or lowercase.
 Use SAS numeric functions such as SUM, MEAN, RAND, SMALLEST,
LARGEST, ROUND, and INT.
 Create SAS date values by using the functions MDY, TODAY, DATE, and
TIME.
 Extract the month, year, and interval from a SAS date value by using the
functions YEAR, QTR, MONTH, and DAY.
 Perform calculations with date and datetime values and time intervals by
using the functions INTCK, INTNX, DATDIF and YRDIF.
 Use SAS functions to convert character data to numeric and vice versa.
 Explain the automatic conversion that SAS uses to convert values
between data types.
 Use the INPUT function to explicitly convert character data values to
numeric values.
 Use the PUT function to explicitly convert numeric data values to
character values.
 Process data using DO LOOPS.
 Explain how iterative DO loops function.
 Use DO loops to eliminate redundant code and to perform repetitive
calculations.
 Use conditional DO loops.
 Use nested DO loops.
 Restructure SAS data sets with PROC TRANSPOSE.
 Select variables to transpose with the VAR statement.
 Rename transposed variables with the ID statement.
 Process data within groups using the BY statement.
 Use PROC TRANSPOSE options (OUT=, PREFIX= and NAME=).
 Use macro variables to simplify program maintenance.
 Create macro variables with the %LET statement
 Use macro variables within SAS programs.
 Identify and resolve programming logic errors.
 Use the PUTLOG Statement in the Data Step to help identify logic errors.
 Use PUTLOG to write the value of a variable, formatted values, or to write
values of all variables.
 Use PUTLOG with Conditional logic.
 Use temporary variables N and ERROR to debug a DATA step.
 Recognize and correct syntax errors.
 Identify the characteristics of SAS statements.
 Define SAS syntax rules including the typical types of syntax errors such
as misspelled keywords, unmatched quotation marks, missing
semicolons, and invalid options.
 Use the log to help diagnose syntax errors in a given program.
 Generate list reports using the PRINT procedure.
 Modify the default behavior of PROC PRINT by adding statements and
options such as
 use the VAR statement to select and order variables.
 calculate totals with a SUM statement.
 select observations with a WHERE statement.
 use the ID statement to identify observations.
 use the BY statement to process groups.
 Generate summary reports and frequency tables using base SAS
 procedures.
 Produce one-way and two-way frequency tables with the FREQ
procedure.
 Enhance frequency tables with options (NLEVELS, ORDER=).
 Use PROC FREQ to validate data in a SAS data set.
 Calculate summary statistics and multilevel summaries using the MEANS
procedure
 Enhance summary tables with options.
 Identify extreme and missing values with the UNIVARIATE procedure.
 Enhance reports system user-defined formats, titles, footnotes and SAS
System reporting options.
 Use PROC FORMAT to define custom formats.
 VALUE statement
 CNTLIN= option
 Use the LABEL statement to define descriptive column headings.
 Control the use of column headings with the LABEL and SPLIT=options in
PROC PRINT output.
 Generate reports using ODS statements.
 Identify the Output Delivery System destinations.
 Create HTML, PDF, RTF, and files with ODS statements.
 Use the STYLE=option to specify a style template.
 Create files that can be viewed in Microsoft Excel.
 Export data
 Create a simple raw data file by using the EXPORT procedure as an
alternative to the DATA step.
 Export data to Microsoft Excel using the SAS/ACCESS XLSX engine.

SAS 9.4 Advanced Programming

 Generate detail reports by working with a single table, joining tables, or

using set operators in SQL
 Use PROC SQL to perform SQL queries.
 Select columns in a table with a SELECT statement and FROM clause.
 Create a table from a query result set.
 Create new calculated columns.
 Assign an alias with the AS keyword.
 Use case logic to select values for a column.
 Retrieve rows that satisfy a condition with a WHERE clause.
 Subset data by calculated columns.
 Join tables - inner joins, full joins (coalesce function), right joins, left joins.
 Combine tables using set operators - union, outer union, except,
intersect.
 Sort data with an ORDER BY clause.
 Assign labels and formats to columns.
 Generate summary reports by working with a single table, joining tables,
or using set operators in the SQL.
 Summarize data across and down columns using summary functions
(AVG, COUNT, MAX, MIN, SUM).
 Group data using GROUP BY clause.
 Filter grouped data using HAVING clause.
 Eliminate duplicate values with the DISTINCT keyword.
 Construct sub-queries and in-line views within an SQL procedure step.
 Subset data by using non-correlated subqueries.
 Reference an in-line view with other views or tables (multiple tables).
 Use SAS SQL procedure enhancements.
 Use SAS data set options with PROC SQL (KEEP=, DROP=, RENAME=,
OBS=).
 Use PROC SQL invocation options (INOBS=, OUTOBS=. NOPRINT,
NUMBER)
 Use SAS functions (SCAN, SUBSTR, LENGTH).
 Access SAS system information by using DICTIONARY tables (members,
tables, columns)
 Create and use user-defined and automatic macro variables within the
SAS Macro Language.
 Define and use macro variables.
 Use macro variable name delimiter. (.)
 Use INTO clause of the SELECT statement in SQL to create a single
variable or a list of variables.
 Use the SYMPUTX routine in a DATA Step to create a single variable or
a list of variables.
 Control variable scope with:
 %GLOBAL statement
 %LOCAL statement
 SYMPUTX scope parameter
 Automate programs by defining and calling macros using the SAS Macro
Language.
 Define a macro using the %MACRO and %MEND statements.
 Calling a macro with and without parameters.
 Document macro functionality with comments
 Generate SAS Code conditionally by using the %IF-%THEN-%ELSE
macro statements or iterative %DO statements.
 Use the SAS AUTOCALL facility to permanently store and call macros.
 Use macro functions.
 Use macro functions. (%SCAN, %SUBSTR, %UPCASE)
 Use macro quoting functions. (%NRSTR, %STR)
 Use macro evaluation functions. (%SYSEVALF)
 Use %SYSFUNC to execute DATA step functions within the SAS Macro
Language.
 Debug macros.
 Trace the flow of execution with the MLOGIC option.
 Examine the generated SAS statements with the MPRINT option.
 Examine macro variable resolution with the SYMBOLGEN option.
 Use the %PUT statement to print information to the log.
 Create data-driven programs using SAS Macro Language.
 Create a series of macro variables.
 Use indirect reference to macro variables. (&&, etc.)
 Incorporate DICTONARY tables in data driven macros.
 Generate repetitive macro calls.
 Process data using 1 and 2 dimensional arrays.
 Define and use character arrays.
 Define and use numeric arrays.
 Create variables with arrays.
 Reference arrays within a DO loop.
 Specify the array dimension with the DIM function.
 Define arrays as temporary arrays.
 Load initial values for an array from a SAS data set.

Clinical Trials Programming

 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 (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.
 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.

Clinical Project
Understanding the Industry
 Drug Development Process
 World Medical Association guidelines
 ICH-GCP guidelines E3,E6,E8,E9
 Protocol Reviews
 Final clinical study report /ISS/ISE/Final clinical report/CSR
 Statistical analysis plan Interpretation
 21 CFR Part 11
 Statistical Programmer Work Process
 Drug Approval Process
 Clinical Trial Study Designs
CDISC Standard Data Structures
 Important Documents Summary(ADRG, SDRG, eCTD etc.,)
 Getting Started from the Case Report Form
 eCRF Portal
 Electronic CRFs (eCRFs)
 Demographics
 Disposition
 Adverse Events
 Exposure
 Concomitant Medications
 Electrocardiogram
 Lab
 Annotating the eCRF
 Annotating Unique eCRF Pages
 Appearance of Annotations
 Annotated CRF Practices

Study Data Tabulation Model (SDTM)

 Variable “Roles”
 SDTM Standard Domains
 SDTM Core Variables
 Clinical Trial Schedule of Assessments

Model for SDTM Generation

 Demographics (DM)
 Disposition (DS)
 Adverse Events (AE)
 Exposure (EX)
 Concomitant Medications (CM)
 Electrocardiogram Test Results (EG)
 Laboratory Test Results (LB)
 Trial Design Domains
 Trial Summary Data Set (TS)
 Trial Arm Data Set (TA)
 Trial Element Data Set (TE)
 Trial Visit Data Set (TV)
 Trial Inclusion/Exclusion Data Set (TI)
 Trial Disease Assessment (TD)

SDTM Metadata Creation

 Table of Contents of Metadata
 Define Header Metadata
 Variable-Level Metadata
 Value-Level Metadata
  Codelist Metadata
 Computational Method Metadata

Analysis Data Model (ADaM)

 ADaM Standard Structures
 Variable “Roles”
 Standard ADaM Structure and Domains
 Standard ADaM Variables
 Subject-Level Analysis Data Set (ADSL)
 Structure of ADSL
 ADSL Specification
 ADSL Programming
 Basic Data Structure (BDS)
 ECG Test Results Analysis Data Sets (ADEG)
 Lab Test Results Analysis Data Sets (ADLB)
 Occurrence Data Structure (OCCDS)
 Adverse Event Analysis Data Set (ADAE)
 Concomitant Medication Analysis Data Set (ADCM)

ADaM Metadata Creation

 Define Header Metadata
 Table of Contents Metadata
 Variable-Level Metadata
 Parameter-Level Metadata
 Computational Method Metadata
 Codelist Metadata
 Analysis Results Metadata
 External Links Metadata
 Case Report Tabulation Data Definition (Define-XML)
 Structure of Define-XML
 The Process of Creating Define-XML
 Create Metadata Spreadsheet and Create Define-XML Components
 Create XPT Files
 Link for External Documents
 Construct Define.XML

Programming
 Validation, Edit check
 Import and export – sql-pass through, accessing the data from an excel,
access using libname statement, proc cport, proc cimport for creating
xport transport files.
 Defining variables once
 Defining baseline obs.
 Imputation Methods-LOCF –Last observation carried forward, BOCF,
 WOCF
 Windowing data
 Transposing
 Time to event data set
 Change from baseline dataset
 Critical variables datasets
 Categorizing
 Study day calculation

CDISC Validation Using Pinnacle 21 Community

 Getting Started with Pinnacle 21 Community
 Running Pinnacle 21 Community (Graphical User Interface)
 Evaluating the Report
 Modifying the Configuration Files
 A Note about Controlled Terminology
 Running Pinnacle 21 Community (Command-Line Mode)
 ADaM Validation with Pinnacle 21 Community
 ADaM Traceability Checks with SAS
 Define.xml Validation with Pinnacle 21 Community

Preparation of TLF's/TLG's viz.,

 Demographic table
 Adverse event table
 Lab shift table
 Listings
 Graphs