We will provide Clinical Data Management - certification course at our institute by 6.5 years experienced person on Clinical research in top multinational companies. Clinical Data Management classes are starting on May 7th 2011 At 10.00 am. For enrolling for the course(weekend batch), please call us at 9480917252.Course duration is 3 months (Saturday -10.00 am to 1 pm & sunday - 10.00 am to 1.00 pm). We will also bring guest lecturers from top MNC's to train our students.

FACULTY PROFILE:

1. Member of  Indian Society for Clinical Research
2. Certified Clinical Data Manager-certified from the Society for Clinical Data Management. USA.
3. Six Sigma Green belt Certified.
4. Member of Drug Information Association
5. 6.5  years of expertise in Clinical Research in top multinational companies.

100% JOB Placement Assistance.

COURSE FEE : Rs. 18000/- Only

Introduction to Pharmaceutical Industry

• The Drug Development Process
• Features of Clinical Trials
• Clinical Development
• Essential Clinical Trial Documents
• Clinical Trials Terminology(Glossary)
• Clinical trial Statistics
• Bioavailability Studies
• Design of Experiments
• Clinical trial delivery model
• Clinical trial business environment
• Audit of Clinical trials

                                                                                                      5hrs

Good Clinical Practice (GCP) Foundations

• History of GCP - milestones in the evolution of GCP
• Principles of GCP
• Applicable GCP Guidelines
• Declaration of Helsinki
• Belmont Report
• Clinical Study Process
• Ethics in Clinical Research
• Informed Consent
• Serious Adverse Event (SAE) Reporting
• Compliance, Auditing & Quality Control in Clinical Research
• ICH- Guidelines

15hrs

Pharma Regulatory Affairs (Clinical Trials)

• Objects & Issues
• Drug Regulatory Authorities
• Regulation of Pharmaceutical Devices
• Regulations on Alternative system of Medicine
• Drug policy in India
• Overview of Regulatory Environment in USA, Australia, Europe & India 
• Clinical Trial Application Requirements in India
• IND/ANDA/NDA- Drug Application
• Regulatory Affairs Profession

                                                                                                                   5 hrs

Clinical Trials Project Planning & Management

• Protocol
• Site feasibility
• Site Start up Activities
• Investigator/Patient Recruitment
• Monitoring
• Auditing
• Compliance
• Site Close-out

Clinical Data Management

Introduction to Clinical Data Management

Data Management Plan

Ø  Definition

Ø  DMP development

Ø  DMP Standard attributes

Ø  DMP Function

CRF Design

Ø  Elements of CRF

Ø  CRF Design team

Ø  CRF design guidelines

Ø  Data points to be captured in CRF

Ø  CRF completion guidelines

Ø  CRF version control

Ø  Best practices

Ø  Activity/Exercise

CDISC- standards

Ø  Introduction

Ø  STDM- standards

Ø  CDASH- Standards

Database Design

Ø  Introduction

Ø  CRF annotation

Ø  Annotation Guidelines

Ø  Database Basics

Ø  Database Validation(UAT)

Ø  Best practices

Validation procedures(Edit Specifications)

Ø  Introduction

Ø  Nature of errors

Ø  Importance of specification

Ø  eCRF specification

Ø  Specification writing

Ø  Edit specification- front end & backend

Ø  Test script writing/ testing

Ø  Case study/ Exercise

Computer system Validation

Ø  Introduction

Ø  21 CFR part 11

Clinical Data Entry

Ø  Introduction

Ø  CRF forecast/tracking

Ø  Entry guidelines

Ø  Types of Data entry

Ø  Best practices

Clinical Data Validation

Ø  Data validation principles/Guidelines

Ø  Importance of cleaning data

Ø  Types of discrepancies

Ø  Manual data Review

Ø  Query processing

Ø  Discrepancy Management

Ø  Medical Coding

Ø  SAE Reconciliation

Ø  External Data Reconciliation/Handling

Ø  Best practices

Electronic Data Management

Ø  Introduction

Ø  Advantages of EDC over traditional system

Ø  Principles & Guidance

Ø  Best practices

Data base lock

Ø  Introduction

Ø  Pre-data base lock activities

Ø  Role of check list

Ø  Authorization for lock

Ø  Perform post lock changes

Ø  Freezing the database

Ø  Best practices

Quality control in CDM

Ø  Terminologies & definitions

Ø  QC process

Ø  Data errors and quality measures

Ø  Quality system approach

Ø  Six Sigma- DMAIC Model

Ø  Best practices