Advanced Post Graduate Diploma 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)
Course Contents:
1. Pharmacovigilance
2. Argus Safety Software
3. Clinical Data Management
4. Oracle Clinical Software
5. Base SAS
6. Advance SAS
7. 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
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:
This is the only Place in India where you can have practical Hands-on experience on Argus Safety database and Oracle Clinical Database
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
We also offer Instructor-Led Online Trainings
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…
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 (Established in the year of 2000)
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
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
You will be extensively involved in Argus Safety:
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
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
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
You will be extensively involved in Oracle Clinical:
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
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
Data entry in RDC and Discrepancy Management in RDC
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
SAS Clinical (Base SAS and Advance SAS)
SAS Modules:
SAS / BASE
SAS / STAT
SAS / REPORT
SAS / ODS
SAS / GRAPH
SAS / SQL
SAS / MACROS
SAS / ACCESS
SAS / CONNECT
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
You will be extensively involved in:
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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