Dear Student,
Advanced PG Diploma with Placement Support in
Pharmacovigilance - Argus Safety Software, Clinical Data
Management – Oracle Clinical Software & SAS Clinical (Base
SAS and Advance SAS) with Live Projects
BioMed Informatics Medwin Hospitals
(Established in the year of 2000)
Total Fee: Rs.35,000/- (This includes all the following course contents)
Course Contents:
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Pharmacovigilance
Argus Safety Software
Clinical Data Management
Oracle Clinical Software
Base SAS
Advance SAS
Live Project
After completion of PG Diploma:
This is the only place in India where you can learn all the softwares
Argus Safety, Oracle Clinical and SAS Clinical in single program by
which you are eligible to apply in the domains of Pharmacovigilance,
Clinical Data Management, Argus Safety, Oracle Clinical & SAS
Clinical in Novartis, Quintiles, TCS, Parexel, MakroCare, Synowledge,
HCL, Tech Mahindra, Wipro, Accenture and many more….
You are eligible for Pharmacovigilance Jobs
You are eligible for Argus safety Jobs in IT Companies
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You are eligible for Clinical data management Jobs
You are eligible for Oracle Clinical Jobs in IT Companies
You are eligible for SAS Jobs in IT Companies
You are also eligible for any healthcare Jobs because of the availability
of the patient data in Medwin Hospitals
Features:
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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
Certificate will be provided after successful completion of the course
Relieving certificate will be provided after getting the job
Resume preparation tips / Interview guidance
Placement Support will be provided
Printed material will be provided
Practical Hands-on training on Databases
Direct access will be provided to 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 Pharmacy/Life Sciences students to enter into
IT Companies and Pharma, Biotech, CRO industries.
Our candidates employed in Novartis, Quintiles, TCS, Parexel International (India) Pvt Ltd,
MakroCare, Synowledge, 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…
We would like to inform you that the tentative schedule for the next batch is 02-09-2015.
Duration is six weeks and the fee is Rs 35,000/-. To reserve the seat immediately, you need to pay
Rs.5,000/-.
Payment methods:
- Do the Cash payment at BioMed Informatics, Hyderabad
- Bank Transfer:
Account Name
: BIOMED INFORMATICS
Current A/C Number
: 345011004722
Name of the Bank
: ING VYSYA (Now Kotak Mahindra)
Branch
: CHIKKADAPALLY
IFSC Code
: VYSA0003450
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Thanking you,
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G.V.L.P.Subba Rao
Mobile: 09989684450
BioMed Informatics (Established in the year of 2000)
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad – 500 001
Phone: 040 – 40209750
Website: www.biomedlifesciences.com
Course Curriculum
Pharmacovigilance
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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
Argus Safety Database
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
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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
You will be extensively involved in Argus Safety:
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Data entry of Individual Case Safety Reports (ICSRs) in to the Argus Safety database
Processing of all incoming cases in order to meet timelines
Writing a detailed medically oriented description of the events in the form of safety narrative.
Perform the duplicate search in Argus safety database
Assessment of seriousness, expectedness/listedness of Adverse Events
Evaluate the entered cases as per quality review checklist in terms of quality, accuracy, and
completeness against the source documents provided
 Performing QC review of the cases to meet case processing timelines
 Coding of adverse events with the help of MedDRA and labeling the events
 Coding of suspect and concomitant drugs using company and WHO-DRUG dictionaries.
 Meeting the timelines and supporting global regulatory submissions in expedited reporting of
ICSRs
 Preparation of PSURs for regulatory submissions
 Entry of Adverse events in Local Affiliate Module (LAM) and Routing Local events to
central Argus safety
 Codelist Configuration in Argus console
 Creating Sites, Users, User groups
 Creating Products, Licenses, Studies and Expedited Reporting Rules
 Configuring Workflow States and rules
 Knowledge of Advanced conditions; Setting up of field validation to ensure consistency of
data
Clinical Data Management
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Introduction to Clinical Research
Introduction to Clinical Data Management
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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
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:
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 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
You will be extensively involved in Oracle Clinical:
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Designing of electronic Case Report Forms (eCRFs) in Oracle Clinical
Creation and maintenance of global library objects like DVGs Questions, Question groups,
DCMs and DCIs
Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry
Generating and Testing data entry screens and validate the range, format, date, missing fields
Conduct study start up activities, like Study design and Defining Sites, investigators and
patients
Creating, generating and testing Data Validation and Derivation procedures
Writing edit checks or validation procedures using ranges provided or in accordance with the
protocol
Performing User Acceptance Testing (UAT)
Data Entry like Initial Login, Key Changes, First Pass and Second Pass Data Entry, Comparison
Reconciliation and Update
Test and execute validation procedures (Both single and batch validation)
Discrepancy management and Query management
Generating queries based on validation checks to clarify and improve the quality of the data
Creating DCFs and maintaining Discrepancies
Resolving queries and updating the database.
Review of un-resolved discrepancies, raise manual discrepancies wherever required and close
where appropriate.
Improving the quality of the data to ensure an error free, accurate data with no open queries
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Establishing and coordinating the timely completion of the database lock procedures.
Reviewing clinical data as per SOP, protocol, and study specific guidelines
Knowledge of Data Extract and SAS extract views
Maintaining Lab ranges, Lab units, Lab test questions
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Data entry in RDC and Discrepancy Management in RDC
Clinical Research
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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
SAS Clinical (Base SAS and Advance SAS)
SAS Modules:
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SAS / BASE
SAS / STAT
SAS / REPORT
SAS / ODS
SAS / GRAPH
SAS / SQL
SAS / MACROS
SAS / ACCESS
SAS / CONNECT
LIVE SAS CLINICAL PROJECT
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SAS / BASE
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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
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Introduction To Biostatistics – Clinical Applications
Frequency Distribution Of Clinical data
Clinical Data Presentation
Measures Of Centering Constants
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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
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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
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Proc Report
Column Statements
Break/Rbreak Statements
Compute Statement
Frequency Procedure
Proc Tabulate
One-Dimensional Tables
Two-Dimensional Tables
Summary Statistics
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Proc Summary
SAS / ODS
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ODS Statements
ODS Options
Using ODS to Create HTML, PDF, RTF
Proc Template
Proc Report with ODS
SAS / SQL
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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
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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
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Import & Export Procedures
Proc Access
Worksheet Statement
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SAS / CONNECT
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Cimport Procedure
Cport Procedure
Using Select Statement
LIVE SAS CLINICAL PROJECT
You will be extensively involved in SAS Clinical:
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Extracting the data from various internal and external databases (Oracle, MS Access, Excel
spreadsheets) using SAS/ACCESS, SAS/INPUT
Developing programs for converting the Oracle data into SAS datasets using SQL Pass
Through Facility
Clinical trial data analysis with different Statistical Procedures
Using various statistical procedures to find out the efficiency of the drug as per 21 CFR
USFDA Guidelines
Interpretation of p-value and drawing conclusions
Assigning subjects to different treatment arms with SAS Randomization Programs
Creating the reports using the SAS procedures and using ODS statements to generate different
output formats like HTML, PDF, RTF and excel to view them in the web browser
Creating the statistical reports using Proc Report, Proc Tabulate and SAS Macro
Thorough understanding of Protocol, Statistical Analysis Plan (SAP)
Analyzing the data and creating tables according to the Statistical Analysis Plan (SAP)
Generating the demographic tables, adverse events and serious adverse events reports
Using the SAS procedures (MEANS, FREQ, SUMMARY, TRANSPOSE, TABULATE,
REPORT etc) and SAS/STAT procedures (REG, CORR, GLM, ANOVA and UNIVARIATE
etc.) for summarization, cross-tabulations and statistical analysis
Manipulation of SAS datasets using SET, MERGE, UPDATE, MODIFY and Conditional
statements
Generating Graphs and Figures using PROC CHART, PROC GCHART, PROC PLOT,
PROC GPLOT and Graph-N-Go
Validation and QC of the efficacy and safety tables
Using PROC EXPORT and Export wizard to Transfer SAS data to external data sources
Providing programming support for the creation and maintenance of programs used in Data
Management, Data Validation, Data Cleaning and Statistical Report Generation
Extensive Applications in SAS/SQL, SAS/ACCESS, SAS/CONNECT and SAS Macros
Generating Tables, Listings, Figures/Graphs (TLFs or TLGs)
Working with datasets such as DM (Demographics), LB (Laboratory), MH (Medical History),
AE (Adverse Events), VS (Vital Signs), CM (Concomitant Medication)
Manipulation and Reporting of clinical data using PROC SQL
Extensive programming in writing and debugging the Macro routines and applying Macro
variables in SAS program
CDISC Standards (SDTM, ADaM, LAB, ODM)
Live SAS Clinical Projects
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