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

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