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The best Online training for CDISC SDTM,SAS Clinical Programming,TLFs And Clinical Data Management.

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Drug development Process
Phase Trials
systems used in clinical
career and scope in clinical
ICH-GCP
21CFR 11
Applicable CFR Regulations
E6,E9,E2 Guidelines

Investigator
Monitor
CRC
Clinical Nurses
IRB
FDA
DCGI

PK,PD
Inform consent process
IB
SOP
DMP

Data Base Setup

Understanding Protocol

CRF -Designing

Visit Structure
Standard Form and TA Forms

eCRF Specification

important elements of e CRF
understanding of Data base
Add entry and log forms
Data Validation
writing edit Checks
conditionals
Derivations and calculations
simple checks
DVS Review
Data Cleaning
Data collection
Data Entry single and double
Query Management

SAE and Lab Reconciliation
Audit and inspections
CDM Qc
CDM UAT


CDISC-SDTM

understanding annotation
Writing Mapping Specification
Classification of Data
Domains
Variables

Course Content

Chapter 1: SAS Introduction
Introduction
Getting Data into SAS
A Sample SAS Program
SAS Names
SAS Data Sets and SAS Data Types

Chapter 2: Writing Your First SAS Program

A Simple Program create a dataset
Making Comment Statements

Chapter 3: Creating Permanent SAS Data Sets

SAS Libraries the LIBNAME Statement
Why Create Permanent SAS Data Sets
Listing All the SAS Data Sets in a SAS Library Using PROC CONTENTS
Using a SAS Data Set as Input to a DATA Step
Use of DATA _NULL STEP

Chapter 4: Creating Formats and Labels

Adding Labels to Your Variables
Using Formats to Enhance Your Output
Regrouping Values Using Formats
Storing Your Formats in a Format Library
Permanent Data Set Attributes
Accessing a Permanent SAS Data Set with User-Defined Formats
Displaying Your Format Definitions

Chapter 5: Reading Raw Data from External Files

Reading External data using proc import
Using In file statement

_________________________________________________________________________________

Chapter 6: Performing Conditional Processing

The IF and ELSE IF Statements
The Subsetting IF Statement
The IN Operator
Using Boolean Logic (AND, OR, and NOT Operators)
The WHERE Statement

Chapter 7: Performing Iterative Processing: Looping

DO Groups 118
The Sum Statement
The Iterative DO Loop

Chapter 8: Working with Dates

How SAS Stores Dates
Reading Date Values from Raw Data
Computing the Number of Years between Two Dates
Demonstrating a Date Constant
Computing the Current Date
Extracting the Day of the Week, Day of the Month, Month, and Year from a SAS Date
Creating a SAS Date from Month, Day, and Year Values
Using Date Interval Functions

Chapter 9: Subsetting and Combining SAS Data Sets

Subsetting a SAS Data Set
Creating More Than One Subset Data Set in One DATA Step
Adding Observations to a SAS Data Set
Combining Detail and Summary Data
Merging Two Data Sets
Omitting the BY Statement in a Merge
Controlling Observations in a Merged Data Set
More Uses for IN= Variables
When Does a DATA Step End?
Merging Two Data Sets with Different BY Variable Names
Merging Two Data Sets with Different BY Variable Data types
__________________________________________________________________________
Chapter 10: Numeric Functions
Functions That Round and Truncate Numeric Values 190
Functions That Work with Missing Values
Setting Character and Numeric Values to Missing
Descriptive Statistics Functions
Computing Sums within an Observation
Mathematical Functions
Computing Some Useful Constants
Generating Random Numbers
Special Functions
Functions That Return Values from Previous Observations

Chapter 11: Character Functions

Determining the Length of a Character Value
Changing the Case of Characters
Removing Characters from Strings
Joining Two or More Strings Together
Removing Leading or Trailing Blanks
Using the COMPRESS Function to Remove Characters from a String
Searching for Characters
Searching for Individual Characters
Searching for Words in a String
Searching for Character Classes
Using the NOT Functions for Data Cleaning
Describing a Real Blockbuster Data Cleaning Function
Extracting Part of a String
Dividing Strings into Words
Comparing Strings
Performing a Fuzzy Match
Substituting Characters or Words
Working with Multiple Observations per Subject 505



________________________________________________________________________
Chapter 12: Working with Multiple Observations per Subject
Identifying the First or Last Observation in a Group
Counting the Number of Visits Using PROC FREQ
Counting the Number of Visits Using PROC MEANS
Computing Differences between Observations
Computing Differences between the First and Last
Observation in a BY Group Using the 3LAG Function
Computing Differences between the First and Last
Observation in a BY Group Using a RETAIN Statement
Using a Retained Variable to Remember a Previous Value

Chapter 13: (PROCEDURES) Summarizing the data and counting frequencies

Proc print
Proc Freq
Proc Means
Proc Transpose
Proc Compare

Chapter 14: Introducing the Output Delivery System

Sending SAS Output to an HTML File
Creating a Table of Contents
Selecting a Different HTML Style
Choosing Other ODS Destinations
Selecting or Excluding Portions of SAS Output
Sending Output to a SAS Data Set

Chapter 15: Introduction to Proc SQL and Macros Basics

Counts by Proc SQL
Proc SQL Joins
Macro Basics (Using %Let etc.)
Project:
Performing 10 Edit Checks through DVS
Creation of 3 summary Tables (Demography, Adverse Event and Concomitant medication).
Creation of a demographic listing.
Creation of a Graph (Only Bar Chart).


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