BioMed Informatics Medwin Hospitals Advanced PG Diploma in Pharmacovigilance (Argus Safety), Clinical Research, Clinical Data Management (Oracle Clinical) & SAS Clinical (Base SAS and Advance SAS) with Live Projects

Advanced PG Diploma in Pharmacovigilance(Argus Safety), Clinical Research, Clinical Data Management(Oracle Clinical), & 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 

·         Project experience certificate will also be provided

·         Placement Support will be provided 

·         Resume preparation tips / Interview guidance  

·         Printed material will be provided

·         Practical Hands-on training on Databases

·         Argus Safety Database & Oracle Clinical Database

     

BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering trainings since the year of 2000 that are helpful for Life Sciences/Pharmacy students to enter into IT Companies and Pharma, Biotech, CRO industries.

Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd, MakroCare, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, 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. 

Contact:

G.V.L.P. Subba Rao

BioMed Informatics

Medwin Hospitals B Block First Floor,

Nampally, Hyderabad-500 001, India

Phone: 040 - 40209750

Website: www.biomedlifesciences.com

Course Curriculum

Pharmacovigilance

• Clinical Development process
• Different phases of Clinical Trials
• History and overview of Pharmacovigilance
• Introduction and responsibilities of USFDA, EMA and CDSCO
• Pharmacovigilance in India
• Adverse Events and its types
• Drug Safety in clinical trials and post marketed drugs
• Different sources of Adverse Events reporting
• Different types of AE Reporting Forms
• Expedited reporting and its timelines
• Different departments working on Pharmacovigilance
• Roles and responsibilities of case receipt unit
• Roles and responsibilities of Triage unit
• Four factors for the reportable case
• Seriousness criteria of adverse event
• Expectedness or Listedness of adverse event
• Causality assessment of the adverse event
• Importance and procedure of duplicate check
• Data Entry
• Case booking or initiation
• Case processing
• MedDRA and WHODD coding
• SAE narrative writing
• Case quality check, Medical review and its submission
• PSUR and its submission timelines

Oracle Argus Safety Database (Optional)

Argus Console:

• PV Overview
• PV Business process
• Introduction to Oracle Argus Safety Database
• Family, Product and License creation
• Study creation
• Sites, users and Groups creation
• Workflow Configuration
• Expedited Report Configuration
• Case priority Configuration
• Case Numbering
• Field Validation
• Code list Configuration
• LAM (Local Affiliate Module) Configuration

Argus Safety:

• Different icons used during the case processing and their purpose.
• Different tabs used in case processing
• Minimum requirements for a case bookin
• Case Bookin and Data entry
• Case Processing
• Case Routing Based on workflow
• Case Quality check, Medical review
• Duplicate case check or verification
• Report Generation for Regulatory Submission
• Expedited Reports and Aggregate Reports
• Case Bookin in LAM and Routing to Central Safety database
• MedDRA coding and WHO DD coding
• Narrative Writing
• Different Case Studies

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

    Clinical Data Management

·                     Introduction to Clinical Research

·                     Introduction to Clinical Data Management

·                     Guidelines for CDM

·                     Roles and Responsibilities of CDM Team

·                     Clinical Data Management Process and Life cycle

·                     Data Management Plan

·                     21 CFR Part 11

·                     CRF Designing

·                     CRF Annotation

·                     Data Capture Methods

·                     Data Entry

·                     Edit Checks

·                     Data Validation Procedures

·                     Discrepancy Management

·                     Data Clarification Forms (DCFs)

·                     Database Locking and Freezing

·                     Data Storage & Archival

·                     Data Coding and Medical Dictionaries

·                     SAE Reconciliation

·                     Quality Assurance & Quality Control

·                     Auditing

·                     CDISC Standards

   Oracle Clinical OC/RDC (Optional)

INTRODUCTION:

• Introduction to OC window
• Subsystems in OC

STUDY PLAN:

• Defining Programs and Projects
• Defining Organization Units
• Defining Regions
• Defining Planned Studies

 STUDY DESIGN:

• Easy Study Design
• Creating Intervals
• Creating Events
• Creating treatment patterns
• Creating Investigator, Site Records and Assignments
• Creating Patient Positions and Assignments

GLIB:

• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Copy Groups

STUDY DEFINITION:

• Creating DCM's, DCI's & DCI Books
• Validation Procedures
• Derivation Procedures
• Test a Study
• Test Data Entry

DATA ENTRY:

• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Missing DCMs

STUDY CONDUCT:

• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Data Extract and SAS Extract
• Making Mass Changes
• Locking and Freezing

LAB:

• Labs
• Lab Ranges
• Lab Units
• Lab test questions
• Lab Assignment Criteria

RDC (Remote Data Capture):

• Data entry in RDC
• Discrepancy Management in RDC

·         Study and Site Security

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 SAS System & 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