Preview to Lessons on Clinical Research - 21 Essential Topics

Biomedical Research

  • Introduction to Biomedical research
  • Objective of Biomedical research
  • Importance/Contribution of Biomedical Research in Healthcare System
  • Brief discussion on elements of Biomedical Research:
  •                            Basic Research
                               Pre-Clinical Research
                               Clinical Research
                               Translational Research

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Central Laboratory 

  • Introduction to Central laboratory
  • Need of Central laboratory
  • Importance of Central laboratory
  • How does Central laboratory work
  • Benefits of Central laboratory


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Clinical Trial Lifecycle

  • Introduction to Clinical Trial
  • Basic overview of the Clinical Trial Process
  • Stages of Clinical Trial explained:
  •                       Trial/Study Initiation
                          Trial/Study conduct
                          Trial/Study close-out


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CRC Vs CRA

  • Introduction to CRC
  • Introduction to CRA
  • CRC functions, roles and responsibilities
  • CRA functions, roles and responsibilities
  • Comparative study of CRC and CRA


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Drug Regulatory Authority of India

  • Introduction to Drug Regulatory Authority
  • Objectives of Drug Regulatory Authority
  • Responsibilities of Drug Regulatory Authority
  • Structure and function of National Drug Regulatory Authority (CDSCO)
  • Structure and function of State Drug Regulatory Authorities
  • Other statutory bodies and advisory committee (who helps Drug Regulatory Authorities in functioning)

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World Health Organization (WHO)

  • Introduction to WHO 
  • Objectives of WHO
  • Core functions of WHO
  • Main bodies of WHO
  • World Health Assembly
  • Executive Board
  • Secretariat
  • WHO Structure
  • How does WHO function
  • WHO collaborating centers
  • Contribution of WHO to Health Care systems

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Types of Clinical Trial

  • Introduction to Clinical Trial
  • Types of Clinical Trial with examples:
  •                     Prevention trial
                          Treatment trial
                          Screening trial
                          Diagnostic trial

                        Behavioral trial
  • Quality of life trial (Supportive care trial)

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Research Idea to Research Protocol   

  • Introduction to Research protocol
  • Need/Importance of Research protocol
  • Origin/generation of Research Idea with examples
  • Creation of research topic
  • Review of research topic for significance and feasibility 
  • Creation of hypothesis and research question
  • Characteristics of a good research question - FINER Criteria
  • Discussion on research objective, variables, research design, outcomes and other research elements which are required for protocol drafting

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Bioavailability & Bioequivalence

  • Introduction to Bioavailability (BA)  
  • Example of Bioavailability 
  • Application of Bioavailability 
  • Benefits of Bioavailability Studies 
  • Introduction to Bioequivalence (BE) 
  • Application of Bioequivalence 
  • Benefits of Bioequivalence 
  • Importance of Bioavailability & Bioequivalence Studies


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CRO Vs SMO 

  • Introduction of CRO
  • Definition of CRO
  • Introduction of SMO
  • Definition of SMO
  • Responsibilities of CRO & SMO
  • Relation between CRO & SMO
  • Comparative study of CRO & SMO

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Endpoints in Clinical Trial 

  • Introduction to Endpoints
  • Examples of Endpoints
  • Introduction to Outcomes
  • Brief discussion on different kinds of Endpoints used in Clinical Trial
  • Primary Endpoint
  • Secondary Endpoint
  • Clinical/Direct Endpoint
  • Surrogate Endpoint
  • Hard Endpoint
  • Soft Endpoint
  • Composite/Combined Endpoint

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Informed Consent Process 

  • Introduction to Informed Consent Process
  • Definition of Informed Consent Process 
  • Importance of Informed Consent
  • Need of Informed Consent 
  • Elements of Informed Consent 
  • Content of Informed Consent Form
  • Details of Informed Consent Process

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Local Lab Vs Central Lab 

  • Introduction to Local laboratory
  • Functions of Local laboratory
  • Advantages and disadvantages of Local laboratory
  • Introduction to Central laboratory
  • Functions of Central laboratory
  • Advantages and disadvantages of Central laboratory
  • Comparative study of Local laboratory and Central laboratory

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Product Complaint 

  • Introduction to product complaint
  • Example of product complaint
  • Categorization of product complaint
  • Sources of product complaint
  • Complaint management
  • Complaint handling process-Overview

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Research Protocol 

  • Introduction to Research Protocol
  • Definition of Research Protocol
  • Need of Research Protocol
  • Importance of Research Protocol
  • Preparation of Research Protocol
  • Content of Research Protocol
  • Points to consider while creating Research Protocol
  • Research Protocol amendment
  • Protocol Exception, Deviations & Violations

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Source Document & Source Data 

  • Importance of proper and efficient documentation
  • Introduction to Source document
  • Example of Source document
  • Types of Source document
  • Purpose of Source document
  • Introduction to Source data
  • ALCOA - explained

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Trial Master File 

  • Introduction to TMF
  • Need of TMF
  • Importance of TMF
  • When to prepare TMF
  • Points to consider while preparing TMF
  • TMF content
  • Documents included in TMF
  • Maintenance of TMF

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Site Management Organization 

  • Introduction to SMO
  • Scope of SMO
  • Need of SMO
  • SMO Services
  • Benefits of SMO
  • Points to remember to be a good SMO

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Principal Investigator (PI) 

  • Principal Investigator -Introduction
  • Responsibilities of Principal Investigator
  • Selection of Principal Investigator/ Requirements to become Principal Investigator
  • Qualities of a good Principal Investigator

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Contract Research Organization (CRO) 

  • Introduction to CRO
  • CRO-Definition
  • Importance of CRO
  • Services provided by CROs 
  • Selection of CRO
  • Points to keep in mind while outsourcing the trial to CRO

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Sponsor 


  • Introduction to Sponsor
  • Roles and responsibilities of Sponsor


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Good Clinical Practice (GCP) Guidelines 

  • Good Clinical Practice (GCP) Guidelines -introduction
  • Origin of GCP
  • Objective of GCP
  • Benefits of GCP
  • GCP Guidelines- Development
  • Importance of GCP Training
  • ICH-GCP Guidelines

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Data Safety Monitoring Board (DSMB) 

  • Introduction to  DSMB
  • Formation of DSMB
  • Role of DSMB
  • How does DSMB work
  • Characteristics of DSMB
  • Need of DSMB

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Clinical Trial – Phases 

  • Introduction of Clinical trials
  • Phases of Clinical trials:
    • Phase 0
    • Phase I
    • Phase II
    • Phase III
    • Phase IV

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Testimonials

Comments from the students/learners who have benefitted from our learning content

your videos helped me to get a job as a case handler two years ago! Now, I love the field and am being trained as a Domain specialist for IT teams! thank you!


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Mam, it was really difficult to understand by own but your video makes very easy to understand and remembering about GVP and other topic that are you discussed. Thankyou so much mam for making videos and request for making more ... Its truly appreciable efforts from your side.

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OMG this is one of the best videos i have seen on trial overview. I am not a medical or research person but working for a pharmaceutical company and wanted an overview. You explained it very well. Thanks a bunch


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