||Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:|
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
Must possess a Graduate, Post Graduate or Ph D Degree in Statistics, Mathematics, Engineer (All), B.Com/M.Com, BBA/MBA, BCA/MCA, Life Sciences (All), Pharmacy (All), Bio Informatics, Bio Technology, MBBS/BDS
|BUSINESS STREAM INDUSTRIES:||Pharmaceutical | Pharmacovigilance | CRO | Healthcare & Hospitality | IT and ITES BPO|
|Software used for training :|| SAS 9.3|
||Following Course Content will be covered during the training:
Module 1: INTRODUCTION
- Welcome and Introduction
- Drug Development and Clinical Trial Phases
- Fundamentals of Clinical Research & Roles in a CRO
- Introduction to SAS in Clinical Data Management.
- Clinical Data Management Process & Life cycle
- Importance of CDISC SDTM in Clinical SAS
- CDISC SDTM Introduction & Standards.
- Clinical SAS Programmer Roles & Responsibilities
- Overview of good clinical practice(GCP)
- What is a protocol?
- What is informed consent?
- What is a placebo?
- What is a control or control group?
- What are the different types of clinical trials?
- Different types of reports generated by programmer in clinical trials?
Module – 2: BASE SAS:
- Introduction To SAS System & Architecture
- History and Various Modules
- Variables & SAS Syntax Rules
- SAS Data Sets
- Data Set Options
- If – Then Else Statement
- Where Statement
- Creating & Redefining Variables
- Reading Raw Data
- Infile Statement with Options
- Multiple Observations and Multiple Datasets.
- Input Styles
- SAS Functions
- Select Statement
- Do Loops
- Leave and Continue Statement s
- Output Statement & Put Statement
- Stop and Error Statement s
- Array Statement
- Modifying and Combining Data Sets
- Updating Master Data Set
- Key Board Macros & Add Abbreviations
- Display Manager Commands
BASE SAS PROCEDURES
- Proc Sort
- Proc Print
- Proc Means
- Proc Freq
- Proc Plot
- Proc Chart
- Proc Compare
- Proc Copy
- Proc Summary
- Proc Append
- Proc Datasets
- Proc Contents
- Proc Delete
- Proc Format
- Proc Printto
- Frequency Report
- One-Way Frequency Report
- Cross Tabular Frequency Report
- Summary Statistic s
- Creating A List Report
- Define Statement
- Order Usage and Group
- Printing Grand Totals
- Rbreak Statement
- Tabulate Procedure
- One-Dimensional Tables
- Two-Dimensional Tables
- Obtaining A Total
- Analysis Variables with options
- Summary Statistics
- Creating Rtf File
- Creating Html File
- Creating Pdf File
- Creating Xml File
MODULE –3: ORACLE-SQL CONCEPTS
- Sql Command Set
- Operators In Sql
- Order By Clause
- Group By Clause
- Having Clause
- Distinct Clause
- Create and Insert
- Deleting, Populating and Updating
- Introduction to SAS/SQL
- Features & Uses
- Data Types, Key Words, & Operators
- Functions, Predicate s & Functions
- Formatting Output
- Group By Clause, Order By Clause & Having Clause
- Case Expression and Conditional Logic.
- Creating, Populating & Deleting Tables
- Alter Table Statement
- Renaming a Table & Columns
- Changing Column’s Length
- Joins & Views
- Import & Export Procedure s
- Importing data from Ms-Access & Ms- Excel
- Importing data from Oracle database
- DbLoad Procedure
- Gchart Procedure
- Vertical, Horizonta l, Pie
- Gplot Procedure
- Mutliple Plots & Overlay
- Symbol Statement
- Title and Footnote Statement's
- Macro Concepts
- Macros And Macro Variables
- Creating Macro Variables
- Using Macro Variables
- Creating Modular Code With Macros
- Invoking A Macro
- Adding Parameter s To Macros
- Macros with Condition al Logic
- Using Various Procedure s In Macros
- Automatic Variables
- Macro Functions
- Including External Macros
Module – 4: SDTM STANDARDS
- Importance of CDISC SDTM in Clinical SAS
- SDTM Introduction & Standards.
- Key SDTM concepts & Understanding the SDTM Standard
- Application of SDTM Standards.
- Annotation of CRF’s
- SDTM Mapping Specification
- Brief overview of the other CDISC concepts like CDASH, ODM.
- Creation of SDTM annotated CRF.
- A detailed review of SDTM concepts.
- SDTM domain models and relationship tables.
- A discussion of common implementation issues.
- Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data.
- Create case report tabulation (CRT) data set specifications per CDISC or sponsor specified requirements.
- How to represent various types of collected data in the SDTM format.
- Implementation of standard clinical data solution best practices from CRF design through data analysis and reporting.
- COMPONENTS OF SAS
- Create TLG,
- SDTM data-sets
- ADaM data-sets
- CDISC Procedure for the CDISC SDTM 3.1 Format