Advanced PG Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance & SAS Clinical (Base SAS and Advance SAS) with Live Projects

BioMed Informatics Medwin Hospitals
In Hyderabad

Price on request
You can also call the Study Centre
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Important information

  • Post Graduate Diploma
  • Hyderabad
  • Duration:
    45 Days
Description


Suitable for: Life Sciences

Important information
Venues

Where and when

Starts Location
On request
Hyderabad
Medwin Hospitals B Block First Floor, Nampally, 500001, Andhra Pradesh, India
See map

Course programme

Advanced PG Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance & SAS Clinical (Base SAS and Advance SAS) with Live Projects

BioMed Informatics Medwin Hospitals

Features:

  • Certificate will be provided after successful completion of the course
  • Job experience certificate will be provided till you are getting placement, because of availability of patients data with us from time to time
  • Job experience certificate will be provided till you are going to abroad
  • This is the only place in India where you can get job experience certificate because of availability of clinical records. This job experience certificate will be very much useful in shortlisting process by companies
  • Relieving certificate will be provided after getting the job
  • Resume preparation tips / Interview guidance
  • Printed material will be provided

Medwin Hospitals, a Multi Speciality Hospital with excellence in modern health care ventures BioMed Informatics (Member of BCIL-DBT) in the field of Clinical Research by keeping in view of the tremendous applications in improving the quality of the health care.

Our candidates employed in Satyam Computers, ICMR, Global Hospitals, Apollo Hospitals, NIMS, Quintiles, Novartis, Glenmark Pharmaceuticals Ltd, Parexel International (India) Pvt Ltd, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, AstraZeneca-UK, Texas Woman’s University-USA and many more…

Interested candidates are kindly requested to fill the enquiry form in the website www.biomedlifesciences.com for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

Thanking you,

G.V.L.P. Subba Rao

Mobile: 09989684450

BioMed Informatics

Medwin Hospitals B Block First Floor,

Nampally, Hyderabad-500 001, India

Phone: 040 - 40209750 / 66821025

Website: www.biomedlifesciences.com

Course Curriculum

Clinical Research

  • Introduction to Clinical Research
  • Pharma Research/Drug Development Process
  • Pre-Clinical Research
  • Clinical Trial Phases (I - IV)
  • IND/NDA/ANDA
  • Ethics in Clinical Research
  • ICH-GCP Guidelines
  • Regulatory Affairs
  • US FDA Guidelines
  • DCGI/Schedule Y
  • EMA
  • CRO Industry
  • IRB / IEC
  • Informed Consent Process
  • Roles and Responsibilities of Clinical Trial Team
  • Site Initiation Study
  • CRF & e-CRF
  • Standard Operating Procedures (SOPs)
  • Investigator Brochure (IB)
  • Protocol Design and Format
  • Investigational Product (IP)
  • Essential Documents for a Clinical Trial
  • Submission & Publication of Clinical Study Report
  • Audits & Inspections

Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Good Pharmacovigilance Practices
  • Pharmacovigilance Plan (ICH E2E)
  • Classification & Reporting of ADRs
  • Periodic Safety Update Reports (PSURs) for Marketed Drugs (ICH E2C)
  • Safety Signal Detection
  • Safety Signal Assessment
  • Reporting of Safety Signals
  • Management of Safety Signals
  • Indian Scenario
  • Risk Management Process
  • Risk MAPs
  • Pharmacoepidemiological Studies
  • Registers
  • Surveys

Clinical Data Management

  • Introduction to Clinical Data Management
  • Guidelines for CDM
  • Roles and Responsibilities of CDM Team
  • 21 CFR Part 11
  • CRF Designing
  • Data Capture Methods
  • Data Entry
  • External Data Loading
  • Data Validation Procedures
  • Data Cleaning
  • Discrepancy Management
  • Query Management
  • Data Clarification Form (DCF)
  • Database Closure and Freezing
  • Data Storage & Archival
  • Data Coding and Medical Dictionaries
  • Safety Data Management (AEs/SAEs)
  • SAE Reconciliation
  • Quality Assurance & Quality Control
  • Auditing
  • CDISC Standards

Live Project

  • Clinical Data Management System
  • Protocol Designing
  • CRF Designing
  • CRF Tracking
  • Study Event Creation
  • Groups Creation
  • Data Entry
  • Data Validation
  • Discrepancy Management
  • Query Management
  • Database Locking
  • Data Security and Data Privacy

SAS Clinical (Base SAS and Advance SAS)

SAS Modules:

Ø SAS / BASE

Ø SAS / STAT

Ø SAS / REPORT

Ø SAS / ODS

Ø SAS / GRAPH

Ø SAS / SQL

Ø SAS / MACROS

Ø SAS / ACCESS

Ø SAS / CONNECT

Ø LIVE SAS CLINICAL PROJECT

SAS / BASE

  • Introduction to SASSystem & Architecture
  • SAS Windowing Environment
  • SAS Libraries
  • Variables & SAS Syntax Rules
  • Data Step and Proc Step
  • Titles & Footnotes
  • Proc Print Statement
  • Proc Print Options
  • Set Statement
  • Dataset Options
  • Options Statement
  • Types of Input Statements
  • Infile Statement With Options
  • Keep, Drop and Rename Statements
  • Update Statement
  • Modify Statement
  • Merging Concepts
  • Interleaving Concept
  • Logical Variables
  • Retain Statement
  • Formats and Informats
  • Conditional Statements
  • SAS Functions
  • Do Statement
  • Randomization

BASE SAS PROCEDURES

  • Proc Sort
  • Proc Append
  • Proc Transpose
  • Proc Contents
  • Proc Format
  • Proc Import
  • Proc Export
  • Proc Compare
  • Proc Copy
  • Proc Options
  • Proc Forms
  • Proc Datasets
  • Proc Printto
  • Proc Calendar

BIOSTATISTICS

  • Introduction To Biostatistics – Clinical Applications
  • Frequency Distribution Of Clinical data
  • Clinical Data Presentation
  • Measures Of Centering Constants
  • Measures Of Dispersion
  • Normal Distribution
  • Null Hypothesis / Alternate Hypothesis
  • p – Value Interpretation
  • Sampling Variation
  • Probability Concepts In Clinical Trials
  • t-Test – Pharma Applications
  • Chi Square test – Adverse Event Analysis
  • Correlation & Regression – Estimation Analysis
  • ANOVA – Efficacy Analysis

SAS / STAT (DATA ANALYSIS)

  • Proc Means (mean, median, std, n, var, cv, range, q, q3, qrange, p50)
  • Proc Univariate
  • Proc Summary
  • Proc TTest (Paired and Unpaired)
  • Proc Anova (One Way, Two Way and Manova)
  • Proc Glm
  • Proc Freq
  • Proc Chisq
  • Proc Corr
  • Proc Reg

SAS / GRAPH

  • Proc Plot
  • Proc Gplot
  • Mutliple Plots & Overlay
  • Symbol Statement
  • Title and Footnote Statements
  • Proc Chart
  • Proc Gchart
  • Vertical, Horizontal, Pie
  • Group, Subgroups
  • Proc G3D
  • Proc Gprint
  • Graph-N-Go

SAS / REPORT

  • Proc Report
  • Column Statements
  • Break/Rbreak Statements
  • Compute Statement
  • Frequency Procedure
  • Proc Tabulate
  • One-Dimensional Tables
  • Two-Dimensional Tables
  • Summary Statistics
  • Proc Summary

SAS / ODS

  • ODS Statements
  • ODS Options
  • Using ODS to Create HTML, PDF, RTF
  • Proc Template
  • Proc Report with ODS

SAS / SQL

  • Introduction to SAS/SQL
  • Proc Sql Statements
  • Proc Sql Options
  • Set Clause
  • Where Clause
  • Order by Clause
  • Group by Clause
  • Having Clause
  • Distinct Clause
  • Formatting Output
  • Case Expression and Conditional Logic
  • Sql Set Operators
  • Joins in Sql
  • Creating ,Populating & Deleting Tables
  • Alter Table Statement
  • Renaming A Table & Columns
  • Changing Column's Length
  • Aggregate Functions
  • Pass Through Facility

SAS / MACROS

  • Macro Concepts
  • Macros And Macro Variables
  • Creating Macro Variables
  • Using Macro Variables
  • Invoking A Macro
  • Passing Arguments to Macros
  • Macro Quoting Functions
  • Macro Options
  • Macro Expressions
  • Macro Character Functions
  • Macro Interface Functions

SAS / ACCESS

  • Import & Export Procedures
  • Proc Access
  • Worksheet Statement

SAS / CONNECT

  • Cimport Procedure
  • Cport Procedure
  • Using Select Statement

LIVE SAS CLINICAL PROJECT


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