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 Pharmacovigilance
In Hyderabad

Rs 35,000
VAT incl.
You can also call the Study Centre
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Important information

  • Workshop
  • Advanced
  • Hyderabad
  • Duration:
    6 Weeks
  • When:
    Flexible
Description

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)


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

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…

Important information Venues

Where and when

Starts Location Timetable
Flexible
Hyderabad
BioMed Informatics, Medwin Hospitals B Block First Floor, Nampally, Hyderabad, 500001, Andhra Pradesh, India
See map

What you'll learn on the course

Drug Research
Clinical Research
Database

Teachers and trainers (1)

Jyothy Kanakala
Jyothy Kanakala
Researcher

Expert in Pharmacovigilance, Clinical Data Management, Argus Safety, Oracle Clinical & SAS Clinical. Involved in • 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

Course programme

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:

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

Additional information




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