Training
sas-cro

SAS Programming in Life Science Industry

$500.00 Including TaxesEnroll

This is a Live Course where the classes will be conducted on a specific timing, by an instructor, on web meeting. The details of the course will be sent you  sent to your registered email ID. For any other specific questions, you can reach us at training@pvrtech.com.

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Program Description

Topics covered in this program.

Understanding Clinical Trial Process

– Terminologies used in Clinical Trials
– Population Sample
– Flow of data from a SAS programmer’s perspective
– QC Process
– Folder Structure

 

Introduction to Study Data Tabulation Model (SDTM)

– Why are there standards ?
– SDTM and ADAM standards
– Define.xml
– SDTM related documents
– SDTM Core variables
– SDTM Variable roles, Identifying variable roles, SDTM Classes, SDTM Domains, SDTM IG,
– Controlled terminology Document

Derivations needed in SDTM

– Attrib Statement
– Retain Statement
– BY Statement and First. and Last.
– Transposing using Data step and PROC TRANSPOSE
– Study Day and Age Calculation
– Creating XPT files
– LOCF
– Baseline Derivation
– EPOCH Derivation
– MedDRA and WHODrug Dictionaries
– Split Text into 200 characters
– CTCAE
– Visit Slotting Derivation
– ISO date

Implementing Finding Class Domains

– Creating and Updating Specification Sheet
– IE domain
XPT file Creation
– VS domain
Baseline Derivation
– LB domain
CTCAE
Supplemental Domain

Implementing Special Purpose Domains

– DM
RFSTDTC RFENDTC variable derivation
Multiple RACE
ARM and ARMCD
SUPPDM derivation
– SV
Visit Slotting
Using SV in LB
– CO
Understanding and Implementing CO.

Generating Table, Listing and Graphs (TLG)

– Documents needed for Table, Listing and Figure programming
– Understanding TLG Shell
– Types of TLG
– Type of Quality Checks for TLG
– Listing Programming
– Graph Programming
– Intro to Table Programming (details in next chapter)

 

Static Tables Programming

– Identifying Dataset, Variables and Subsetting criteria by looking at Table Shell
– Calculating Frequencies and macrotize the code
– Calculating Summary Statistics and macrotize the code
– Invoking Autocall facility
– Generating Report using PROC REPORT

 

Static Tables Programming_Production and QC Program

– Understanding QC process
– Understanding how to write Production Program
– Understanding how to write QC program

 

Programming Implementation_Dynamic and Combination Tables_Production and QC

– Understanding Data Driven Tables
– Production Program for Data Driven Table
– QC Program for Data Driven Tables

 

Understanding Combination Table

– Production Program for Combination Table
– QC Program for Combination Table
– Alternate QC Using %readrtf

 

Annotating CRF with SDTM variables

– Finding the documents needed to implement SDTM
– Flow chart for Annotating CRF
– Understanding CDISC guidelines for Annotating CRF
– Understanding different ways of Annotating CRF
– Annotating Supplemental dataset
– Practical Demonstration of Annotating AG102 CRF

 

ADaM Theory

– Analysis Data Model Introduction
– Flow of Data in Clinical Trial
– SDTM vs ADaM
– Fundamentals of ADaM
– Analysis Dataset Subject Level
– Basic Data Structure

 

Derivations in ADaM

– Windowing Logic
– Last Observation Carry Forward (LOCF) and Worst Observation Carry Forward (WOCF)
– Impute Dates
– Treatment Emergent Flag
– PARAMTYP and DTYPE variable

 

ADaM Programming

– Programming following analysis datasets
– Analysis Dataset Subject Level (ADSL)
– Analysis Dataset Adverse Event (ADAE)
– Analysis Dataset Pain Score (ADXP)
– Analysis Dataset Laboratory Results (ADLB)
– Analysis Dataset Efficacy Dataset (ADEFF)
– Analysis Dataset Time to Event Dataset (ADTTE)

 

Submission Readiness

– Understanding Metadata
– Updating Metadata
– Understanding Define.xml
– Creating Define.xml
– Validating Define.xml using OPEN CDISC
– Validating SDTM using OPEN CDISC
– Correcting Error and Warnings from Open CDISC Report
– Supporting Documents that go in submission

 

FDA

– Why is it important?
– Guidelines and Process
– Limitations
– Supporting Documents that go in submission

 

First Day of Work

– What to expect on First Day?
– What to ask and what not to ask?
– Connecting to Unix Server and Navigating in it
– Mapping and Navigating folder Structure
– Adding things in Favorite for faster retrieval

 

Start Date End Date Days Time Batch Name
2-Sep-2016 30-Oct-2016 Monday, Wednesday and Friday 9:30 am EST to 11:00 am EST SAS Programming – Morning – Batch 24
2-Sep-2016 30-Oct-2016 Monday, Wednesday and Friday 3:30 pm EST to 5:00 pm EST SAS Programming – Morning – Batch 25
2-Sep-2016 30-Oct-2016 Monday, Wednesday and Friday 6:30 pm EST to 8:00 pm EST SAS Programming – Morning – Batch 26
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