Syllabus – Clinical Research

Clinical Research
  • Introduction of clinical researchClinical Trial Phases
    Pharmacological Principal Of Clinical Research
    Drug Development And Launch
  • Indian Regulation (domestic regulation)ICH GCP
    Schedule Y
    ICMR
    Indian GCP
  • Key Stakeholders In Clinical ResearchEthics Committees And Institutional Review Board
    Responsibilities Of Sponsor
    Responsibilities Of Investigator
    Responsibilities Of Sponsor – Investigator
    Responsibilities Of Sponsor – Vendor
  • Clinical Trial Design And Project ManagementsClinical Trial Design
    Vendor Selection And Managements
    Project Planning
    Project Managements
  • Principles of good clinical practicesProtocol Design
    CRF Design
  • Essential documents in clinical research and regulatory requirementsEssential Documents
    IND Application
    Clinical Study Report
    NDA Application
    Informed Consent process And Documentation
  • Study setup processSite Selection And Pre- Study VIsits
    Site Initiation
    Subject Recruitment And Retention Planning
    Site Contract And Budgeting
Quality Assurance GCP Audits & Inspections
  • QC & QA, Compliance & Auditing & Inspections21 CRF Part 11
    Site Auditing
    Sponsor Compliance And Auditing
    SOP For Clinical Research
Roles & Responsibility Lead & Principle investigator
  • Clinical Monitoring ActivitiesCRF Review & Source Data Verification
    Drug Safety Reporting
    Drug Accountability Work
    Routine Site Monitoring
    Site Close Out Visit
GCP Audits & Inspection