Preview to Lessons on Clinical Research - 25 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
Central Laboratory
- Introduction to Central laboratory
- Need of Central laboratory
- Importance of Central laboratory
- How does Central laboratory work
- Benefits of Central laboratory
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
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
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)
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
Types of Clinical Trial
- Introduction to Clinical Trial
- Types of Clinical Trial with examples: Prevention trial
- Quality of life trial (Supportive care trial)
Treatment trial
Screening trial
Diagnostic trial
Behavioral trial
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
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
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
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
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
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
Product Complaint
- Introduction to product complaint
- Example of product complaint
- Categorization of product complaint
- Sources of product complaint
- Complaint management
- Complaint handling process-Overview
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
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
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
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
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
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
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
Data Safety Monitoring Board (DSMB)
- Introduction to DSMB
- Formation of DSMB
- Role of DSMB
- How does DSMB work
- Characteristics of DSMB
- Need of DSMB
Clinical Trial – Phases
- Introduction of Clinical trials
- Phases of Clinical trials:
- Phase 0
- Phase I
- Phase II
- Phase III
- Phase IV
Clinical Research Coordinator (CRC)
- Origin of GCP
- CRC - Introduction
- Roles and responsibilities of CRC
- Educational requirements to become a CRC
- Required skills to become a CRC
- Organizations where CRC can work
Role of Ethics committee in Clinical Research
- Introduction to Ethics Committee
- Structure of Ethics Committees
- Institutional Ethics Committee (Institutional Review Board)
- Independent Ethics Committee
- Constitution of Ethics Committee
- Objective of Ethics Committee
- Role of Ethics Committees in Clinical Research
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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