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Clinical Research Overview

GCP

​1. FOUNDATIONS OF CLINICAL RESEARCH & GCP:

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This course will provide an overview of the drug development process and a background of clinical research with emphasis on the Good Clinical Practice Guidelines and Schedule Y, through highly interactive with many exercises and discussions

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Topics to be covered:  

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  • Overview of Drug Development & Clinical Trial Process

  • ICH-GCP & Indian GCP Regulations

  • Schedule Y

  • Role of IEC or IRB in Clinical Research

  • Informed Consent Process

  • Sponsor Responsibilities

  • Investigator Responsibilities

  • Safety Reporting

  • Monitoring a Clinical Study

  • Supply and Handling of Investigational Product

  • Audit and Inspections

  • Data Management & Statistics in Clinical Research

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Ethics Comittee

​2. ETHICS COMMITTEE- COMPOSITION AND FUNCTION:

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This course will provide you with a background of the evolution of ethics committees and help you understand the structure and functioning of the Independent Ethics committee (IEC) or Institutional Review Board (IRB). It will also focus on the GCP requirements for clinical trials that pertain to ethics, from the perspective of sponsors and investigators. An outline of the course covering different topics is as follows –

  • Origin of concept of ethical review and the need for it.

  • Independent Ethics Committees (IECs) –composition and function

  • Sponsor Responsibilities

  • Investigator Responsibilities

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Protocol Design

​3. ADVANCED MODULE ON PROTOCOL DESIGN:

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​This course will help you understand different components of protocol and appreciate interrelationships between components. It will also help you in comprehend design of case report form (CRF) and practice preparation of protocol & CRF. An outline of the course covering different topics is as follows –

  • Overview of protocol writing-

  • Background and Objectives

  • Study Designs

  • Criteria of Selection & Withdrawal

  • Drug Treatments and Placebo

  • End-points and Variables

  • Statistical Issues

  • Case Report form (CRF) design 

  • Ethical considerations

  • Protocol for Bioequivalence study

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Overview

4. OVERVIEW OF CLINICAL RESEARCH AND GCP FOR INVESTIGATORS:

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​This course will provide an overview of clinical research and Good Clinical Practice (GCP) guidelines requirements. An outline of the course covering different topics is as follows –

  • Why clinical research?

  • GCP for investigators

  • Shaping a research proposal

  • Ethical considerations

  • Statistical considerations in protocol writing

  • How to write a publication?

Regulations

5. REGULATIONS IN CLINICAL RESEARCH:

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This course will provide an overview of Regulatory requirements for new drug applications and marketing approvals. It will also touch upon US, European and Indian regulatory system framework. An outline of the course covering different topics is as follows –

  • Regulation in Clinical Research-Evolution and History

  • US Regulatory Structure

  • Investigational New Drug ,New Drug Application and Generics

  • Post Drug Approval Activities

  • Safety Reporting requirements

  • Patents

  • EMEA Organization and Function

  • EU Licensing system

  • EC Directive on Clinical trials

  • Indian Regulatory System

  • Schedule Y, Rules and regulations

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CRFs

​6. DESIGNING CASE REPORT FORMS:

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This course will help you the understand important elements of CRF, comprehend design of case report form and a brief look at e-CRF. An outline of the course covering different topics is as follows –

  • CRF-A Bridge between protocol and study report

  • Benefits of a well designed CRF

  • Structure of CRF

  • Modules in a CRF

  • Electronic CRFs- the way ahead

  • eCRFs- structure and methodology

  • Softwares for eCRFs

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Advanc CR

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7. CLINICAL RESEARCH - FROM THEORY TO PRACTICE:

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The objectives of the workshop are:

  • Clear understanding of clinical research process from planning to execution

  • Hands on training in various workflows and tools used in clinical study management and monitoring

  • Apply conceptual understanding through exercises and case studies. 

  • Topics to be covered:

  • Overview of GCP and Indian GCP

  • Study Placement and Plan

  • Study Start-up

  • Study Management

  • Study Conduct

  • Publication Issues in a clinical study

  • Premature termination of a clinical study

  • Integrating the clinical study activities

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