Advanced Diploma in Clinical Research
 

INTRODUCTION :Clinical research in industry world over is growing at an unprecedented rate. It has opened up new vistces ofemployment opportunities for a large number of trained professionals.The advanced diploma in clinical research targets the requirements of both CROS & SMOs unlike the class room course here the emphasis is provided on, the hands on training.

Module 1 Introduction to Clinical Research

Module 2 The Drug Development Process

What is a Drug?

Pharmacokinetics and Pharmacodynamics
Drug Development
      The components of an IND
      Clinical Development Plan
      Phases of clinical Research

Regulatory Requirements & Guidelines

   Declaration of Helsinki
  Role of FDA
  ICH Guidelines
  HIPAA
  Good Clinical Practice

Roles & Responsibilities

  Sponsor's staff
  Study Site Staff

Required Study Site infrastructure

  Equipment
  Study staff
  Structure & role of IRB/IEC
  Informed Consent process
  Standard Operating Procedures

Module 3 STUDY INITIATION ACTIVITIES

Study Site Staff's Evaluation of Study

  Investigator Brochure
  Protocol
  Existing site facilities

Sponsor Evaluation of the Study Site

  The Pre-study Visit
  Study Site Documentation
  Investigator's Essential Document File

Documents required for Study Initiation

  Signed Protocol
  Form FDA 1572
  CVs
  Financial Disclosure
  IRB/IEC approval
  Lab documentation
  Study Document Review Stimulation
  Preparing the Study Budget
  Managing Clinical Study Supplies
The Study Initiation Visit

Module 4 ONGOING STUDY ACTIVITIES
 
  Case Report Forms & Source Documents
  Enrolling & Retaining Subjects
  Performing Evaluations
  Adverse Events
  Sponsor Monitor Visits
  Ongoing Reports
  Drug Accountability

Module 5 STUDY CLOSE-OUT ACTIVITIES

  Subject Completion/Termination
  Sponsor Closeout Visit
  Final Drug Accountability
  Required Final Reports
  Archiving the Master File
  Sponsor & Regulatory Audits

Module 6: BA and BE studies-A brief Discussion

Upon Completion of the course you will understand:
● How new drugs are discovered, developed and approved for marketing
● Regulatory requirements for conducting studies
● The various phases of clinical drug development and types of clinical trials
● The roles and responsibilities of the Sponsor, Study Site Staff and     
   Regulatory Agencies
● What equipment and staffing are required
● How to evaluate a study protocol
● The IRB requirements and their study approval process
● The requirements for Informed Consent and the consent process
● The impact of HIPAA on clinical trials
● The requirements for advertising for subjects and subject reimbursement
● What a sponsor looks for in selecting a study site
● The requirements for Study Documentation and how to set-up an
   Investigator's Master File
● The requirements for records retention
● The required documentation for initiating a clinical study
● FDA Form 1572
● How to complete a study budget
● How to manage investigational study drug supplies
● The Study Initiation Visit
● Drug supply records and how to do drug accountability
● How to interact with the sponsor
● How to record, review and correct clinical study data
● How to evaluate, classify and report adverse events
● What to do to formerly close-out a study
● Reporting requirements to IRB and sponsor

MODULE 7 REGULATORY AFFAIRS

MODULE 8 PRINCIPLES OF ICH & GCP GUIDELINES

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation bythe regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA

INTRODUCTION
GLOSSARY
THE PRINCIPLES OF ICH & GCP
INSTITUTIONAL REVIEW BOARD / INDEPENDENT

MODULE 9 ETHICS COMMITTEE (IRB/IEC)

Responsibilities
Composition, Functions and Operations
Procedures
Records

MODULE 10 INVESTIGATOR

Investigator's Qualifications and Agreements
Adequate Resources
Medical Care of Trial Subjects
Communication with IRB/IEC
Compliance with Protocol
Investigational Product(s)
Randomization Procedures and Unblinding
Informed Consent of Trial Subjects
Records and Reports
Progress Reports
Safety Reporting
Premature Termination or Suspension of a Trial
Final Report(s) by Investigator

MODULE 11 SPONSOR

Quality Assurance and Quality Control
Contract Research Organization (CRO)
Medical Expertise

MODULE 12 TRIAL DESIGN

Trial Management, Data Handling, and Record Keeping
Investigator Selection
Allocation of Responsibilities
Compensation to Subjects and Investigators
Financing
Notification/Submission to Regulatory Authority(ies)
Confirmation of Review by IRB/IEC
Information on Investigational Product(s)
Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
Supplying and Handling Investigational Product(s)
Record Access
Safety Information
Adverse Drug Reaction Reporting

MODULE 13 MONITORING

Purpose
Selection and Qualifications of Monitors
Extent and Nature of Monitoring
Monitor's Responsibilities
Monitoring Procedures
Monitoring Report

MODULE 14 AUDIT

Purpose
Selection and Qualification of Auditors
Auditing Procedures
Noncompliance
Premature Termination of a Trial
Clinical Trial/Study Reports
Multicentre Trials

Module 15 CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)

General Information
Background Information
Trial Objectives and Purpose
Trial Design
Selection and Withdrawal of Subjects
Treatment of Subjects
Assessment of Efficacy
Assessment of Safety
Statistics
Direct Access to Source Data/Documents
Quality Control and Quality Assurance Procedures
Ethics
Data Handling and Record Keeping
Financing and Insurance
Publication Policy
Supplements

Duration : 6 Months

Eligibility : B.Sc. / M.sc. (all Streams of Life Sciences) B.E. /B.Tech. (Chemical / Biotech/ Computer Science) M.C.A.,B.Pharma, M.Pharma, M.B.B.S. / M.D. / B.D.S. / M.D.S. /B.P.T.

 

DIPLOMA IS SAS PROGRAMMING

Course contents

Getting Started with SAS
· overview of the SAS Systems
· introduction to SAS programs
· running SAS programs
· mastering fundamental concepts
· diagnosing and correcting syntax errors
· exploring the SAS environment (self-study)

Getting Familiar with SAS Data Sets
· explaining the concept of a SAS data library
· Producing List Reports
· Enhancing Output
· Creating SAS Data Sets
· Programming with the DATA step
· Combining SAS Data sets
· Producing summary Reports
· Introduction to Graphics using SAS/GRAPH Software (Self-Study)
· Additional Resources Using SAS Enterprise Guide
· Introduction to Graphics Using SAS Enterprise Guide
· Manipulating Data with the data setup

Advanced Techniques and Efficiencies

Duration : 1 Month

Eligibility : B.Sc. / M.sc. (all Streams of Life Sciences) B.E. /B.Tech. (Chemical / Biotech/ Computer Science) M.C.A.,B.Pharma, M.Pharma, M.B.B.S. / M.D. / B.D.S. / M.D.S. /B.P.T.

 

ADVANCED DIPLOMA IN SAS PROGRAMMING

COURSE CONTENTS

Introduction
· measuring efficiencies
· SAS processing
· controlling memory and I/O resources

Accessing Observations
· creating a sample data set
· creating and using an index

Combining Data Horizontally

Combining Data Vertically

BY-Group Processing and Sorting

Using Lookup Tables to Match Data

Controlling Data Storage Space

Utilizing Best Practices to Improve Efficiency

Using the Scalable Performance Data Engine

SQL Processing using SAS

SAS Macro Language

Using SAS Data Integration Studio to Build Data Marts from Enterprises
Data sources

Creating and Exploiting OLAP using SAS System

Using the SAS Data Quality solution to cleanse your data

Server-Side Web application Development using web AF

Duration : 2 Months

Eligibility : B.Sc. / M.sc. (all Streams of Life Sciences) B.E. /B.Tech. (Chemical / Biotech/ Computer Science) M.C.A.,B.Pharma, M.Pharma, M.B.B.S. / M.D. / B.D.S. / M.D.S. /B.P.T.